<ichicsr lang="en">
  <ichicsrmessageheader>
    <messagetype>ICSR</messagetype>
    <messageformatversion>2.1</messageformatversion>
    <messageformatrelease>1.0</messageformatrelease>
    <messagenumb>2010-12</messagenumb>
    <messagesenderidentifier>FDA CDER ODS</messagesenderidentifier>
    <messagereceiveridentifier>Public Use</messagereceiveridentifier>
    <messagedateformat>204</messagedateformat>
    <messagedate>2011041106:18:05</messagedate>
  </ichicsrmessageheader>
  <safetyreport>
    <safetyreportid>7129978-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-US371024</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070302</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>5 MG TWO TABLETS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-CODAMOL</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-CODAMOL</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDRONEL</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDRONEL</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAMORPH SR</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAMORPH SR</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL CITRATE</medicinalproduct>
        <drugdosagetext>100 MG (FREQUENCY UNKNOWN)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL CITRATE</medicinalproduct>
        <drugdosagetext>100 MG (FREQUENCY UNKNOWN)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7129979-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2006BI015200</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>72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAESTHETIC COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER IN SITU</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER STAGE I</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMANTADINE HCL</medicinalproduct>
        <drugindication>FATIGUE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>HIATUS HERNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7129980-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2007BI007515</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>
      <patientweight>88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLON CANCER</reactionmeddrapt>
      </reaction>
      <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>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7129981-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI011655</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>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE LEIOMYOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7129982-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI032150</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>BREAST CANCER</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>20000411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7129983-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI035357</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>OVARIAN ADENOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7129984-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI036611</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>OBESITY SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7129985-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI038751</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>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030118</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7129986-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI039125</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>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</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>20070106</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7129987-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI039151</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>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080627</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7129988-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI039362</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>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UROSEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990715</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7129989-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI039574</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>108</patientweight>
      <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>20100923</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7129990-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI039734</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GOITRE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32125</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7129991-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041099</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>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081010</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7129992-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041108</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>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7129993-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041445</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>MALIGNANT MELANOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091009</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070823</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7129994-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041446</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>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000811</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7129995-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041514</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7129996-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041516</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100407</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7129997-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041518</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</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>20001122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7129998-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2009BI031164</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>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF REPAIR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070102</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7129999-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI006412</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>74</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR VENOUS ACCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100921</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130000-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI006679</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>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090311</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTYNIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130001-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI006787</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <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>20071129</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130002-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI007165</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>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGRAPHIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100419</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130003-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI015710</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>62</patientweight>
      <patientsex>2</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>20100409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100409</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100228</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130004-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BIOGENIDEC-2010BI023818</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>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100412</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100707</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HRT (NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUMATRIPTAN SUCCINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130005-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI032193</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>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</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>20100324</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130006-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI032927</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>CARDIAC FAILURE CONGESTIVE</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>20100518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100518</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130007-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI033599</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>LUNG CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130008-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI034591</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC VARICES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PORTAL VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENIC INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090305</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NADOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
        <drugdosagetext>DOSE UNIT:2</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130009-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI040495</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>GASTRIC BANDING</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>7130010-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI040504</companynumb>
    <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 STONE REMOVAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090914</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130011-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI040668</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>LOWER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UMBILICAL HERNIA, OBSTRUCTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130012-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI040681</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>HIP ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130013-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI040848</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>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081223</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130014-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-BIOGENIDEC-2010BI041066</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</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>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130015-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-BIOGENIDEC-2010BI041353</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>LENTIGO MALIGNA STAGE UNSPECIFIED</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>20100922</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130016-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BIOGENIDEC-2010BI041368</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>CHRONIC LYMPHOCYTIC LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugbatchnumb>100086A</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED IMMUNOSUPRESSANT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130017-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041453</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>NUCLEAR MAGNETIC RESONANCE IMAGING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091012</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130018-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-BIOGENIDEC-2010BI041520</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130019-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>172900</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>83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGEN</medicinalproduct>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugindication>ROUTINE HEALTH MAINTENANCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
        <drugindication>VERTIGO</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKELAXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130020-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ACTELION-A-CH2010-40025</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</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>TRACLEER</medicinalproduct>
        <drugbatchnumb>AP 066A0318</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>31.25 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130021-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI039351</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>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130022-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041532</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>DRUG TOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32135</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100813</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130023-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041538</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>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32124</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060421</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130024-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI008403</companynumb>
    <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>FATIGUE</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>20100215</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130025-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI016234</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR VENOUS ACCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100106</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130026-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI016594</companynumb>
    <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>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080710</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130027-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI017035</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>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130028-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI018614</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>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</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>20061108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100811</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130029-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI019510</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100512</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130030-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI019925</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>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPIDERMOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLISTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100927</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130031-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI020724</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010514</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130032-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI021522</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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR VENOUS ACCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VEIN DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100826</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040126</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130033-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI021763</companynumb>
    <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>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEARING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL FIELD DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS (NOS)</medicinalproduct>
        <drugindication>PROPHYLAXIS URINARY TRACT INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130034-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI022527</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>DRUG SPECIFIC ANTIBODY PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL HYPOTENSION</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>20091116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100716</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130035-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI022754</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>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGRAPHIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100114</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130036-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI028634</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>EPSTEIN-BARR VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</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>20070205</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130037-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI028979</companynumb>
    <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>MUSCLE SPASTICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070411</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130038-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI029363</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>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOCAL CORD PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081218</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugindication>DIZZINESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugindication>ANGER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS RELAPSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugindication>HEMIPARESIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugindication>VERTIGO</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugindication>APHONIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130039-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI029959</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091008</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130040-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI031724</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>POOR VENOUS ACCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VEIN DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070705</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130041-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI032070</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>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080605</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130042-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI033811</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</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>20070116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080703</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130043-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI033975</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>BACK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGAMENT RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE STRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080320</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130044-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI034356</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 PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</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>7130045-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI034809</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>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130046-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI035840</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</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>20100506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130047-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI036258</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 PAIN UPPER</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>20101001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130048-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI040208</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>JC VIRUS TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130049-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI040501</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>HERPES ZOSTER</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>20090501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130050-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI040693</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>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090825</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130051-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI040894</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>BLEPHAROSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONTROL OF LEGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS FLOATERS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100928</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130052-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI040896</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>URINARY TRACT INFECTION</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>7130053-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041075</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130054-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041084</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>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAND FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090423</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080918</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130055-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041107</companynumb>
    <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>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130056-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041128</companynumb>
    <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>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130057-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041143</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>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130058-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041436</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>H1N1 INFLUENZA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080425</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130059-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041444</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130060-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041473</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130061-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041475</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>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071221</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130062-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041486</companynumb>
    <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>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130063-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041488</companynumb>
    <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 DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090213</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130064-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041489</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>20101025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPASM PILLS (NOS)</medicinalproduct>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130065-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041491</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>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101028</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130066-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041493</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>INFUSION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR VENOUS ACCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100625</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130067-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041495</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>NEURALGIA</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>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130068-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041499</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</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>20090319</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071220</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130069-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041504</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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101109</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130070-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041505</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>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080827</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130071-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041507</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100810</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130072-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041508</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>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101111</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130073-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041509</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>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100308</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130074-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041510</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>FATIGUE</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>20101112</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130075-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041512</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>CHILLS</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>20101122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100914</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130076-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041513</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>INFLUENZA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100518</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130077-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041515</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>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080407</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130078-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041517</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>OCULAR DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091007</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130079-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041519</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>BALANCE DISORDER</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>20090128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130080-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041521</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>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130081-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041522</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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL MYCOTIC INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101005</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130082-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041523</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>GASTROINTESTINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090609</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130083-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041526</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>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080319</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130084-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041527</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>
      <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>20090929</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130085-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041540</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>GASTROENTERITIS VIRAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070112</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130086-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041545</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>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080707</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130087-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041546</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>CONTUSION</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>20100320</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130088-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041557</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>JC VIRUS TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090107</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130089-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041558</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>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100407</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130090-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041559</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>ASTHENIA</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>20100923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100904</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090807</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130091-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041561</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101103</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130092-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041563</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>1</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>20070723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090518</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100216</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130093-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041564</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>JOINT RANGE OF MOTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080705</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130094-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041575</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>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130095-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041576</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>DRUG SPECIFIC ANTIBODY PRESENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080925</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130096-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041578</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>NAUSEA</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>20100303</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130097-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041584</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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100628</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130098-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041591</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>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130099-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041593</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>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130100-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041598</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>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130101-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041615</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>PROCTITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061205</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130102-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041627</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>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</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>20101020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100408</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130103-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041631</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>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081203</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130104-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041633</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>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <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>20080121</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130105-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041636</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070321</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130106-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041642</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>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>YELLOW SKIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100420</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130107-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041651</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101028</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130108-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041653</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>CONSTIPATION</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>7130109-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041654</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>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101026</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130110-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041658</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>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100816</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130111-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041660</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>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100518</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130112-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041662</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>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101111</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130113-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041667</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</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>20100810</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130114-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041668</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>JC VIRUS TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070809</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130115-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041669</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130116-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041671</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>BLOOD COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130117-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041684</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>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</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>20101110</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130118-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041691</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>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080903</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130119-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041704</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>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100713</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130120-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090603</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2009BI016965</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>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGRAPHIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR OF FALLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</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>20081007</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130121-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091028</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2009BI035112</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>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</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>20090922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091020</drugenddate>
      </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>7130122-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2009BI039905</companynumb>
    <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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</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>20071009</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130123-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-AMGEN-COLCT2010002666</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HIP ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130124-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028944</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HAEMOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD LIQUID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130125-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20081001</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-CELGENEUS-056-21880-08100204</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOPRAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOCTRAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130126-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10040800</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>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FULL BLOOD COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION VIRAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090429</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130127-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10112175</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>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR ASSOCIATED FEVER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100821</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130128-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10102675</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>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100621</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130129-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-09090772</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>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELOFIBROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091209</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130130-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10112789</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>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FULL BLOOD COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130131-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-CELGENEUS-020-20785-10112289</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPIDERMOLYSIS BULLOSA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>020785</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPIDERMOLYSIS BULLOSA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EPIDERMOLYSIS BULLOSA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EPIDERMOLYSIS BULLOSA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAPSONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EPIDERMOLYSIS BULLOSA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130132-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-CELGENEUS-062-21880-10102097</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>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOPULMONARY ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091201</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100827</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100827</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130133-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-CELGENEUS-083-21880-10100707</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</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>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100310</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100310</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100310</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100930</drugenddate>
        <drugtreatmentduration>203</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100930</drugenddate>
        <drugtreatmentduration>203</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130134-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-CELGENEUS-083-21880-10101266</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>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130135-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-CELGENEUS-056-21880-10072397</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>DENGUE FEVER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130136-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101015</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-RANBAXY-2010RR-39799</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIPOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugauthorizationnumb>075944</drugauthorizationnumb>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130137-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-RANBAXY-2010RR-39674</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>DERMATITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugauthorizationnumb>078849</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100713</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELONTRIL</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100708</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130138-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-RANBAXY-2010RR-37596</companynumb>
    <primarysource>
      <reportercountry>INDIA</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>CROSS SENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>077977</drugauthorizationnumb>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugindication>PANIC ATTACK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>077977</drugauthorizationnumb>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugdosagetext>12.5 MG, UNK</drugdosagetext>
        <drugindication>PANIC ATTACK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>1.5 MG, UNK</drugdosagetext>
        <drugindication>PANIC ATTACK</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130139-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2010R1-39702</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugauthorizationnumb>076445</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREGABALIN</medicinalproduct>
        <drugdosagetext>75 MG, BID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TRIGEMINAL NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugtreatmentduration>61</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugtreatmentduration>61</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130140-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2010R1-39739</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>
      <patientweight>122.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugauthorizationnumb>077974</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXENATIDE</medicinalproduct>
        <drugdosagetext>UNK, BID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRUSEMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugdosagetext>UNK, 1 DAYS</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugdosagetext>UNK, 1 DAYS</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>UNK, TID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130141-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2009RR-25444</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugbatchnumb>7320</drugbatchnumb>
        <drugauthorizationnumb>065382</drugauthorizationnumb>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugdosagetext>80 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN</medicinalproduct>
        <drugdosagetext>15 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO DYDRAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130142-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-RANBAXY-2010RR-39677</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</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>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEXUAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugauthorizationnumb>077977</drugauthorizationnumb>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE</medicinalproduct>
        <drugdosagetext>37.5 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DULOXETINE</medicinalproduct>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMIPRAMINE</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOMIPRAMINE</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINOXIDE</medicinalproduct>
        <drugdosagetext>180 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPROPION</medicinalproduct>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOCLOBEMIDE</medicinalproduct>
        <drugdosagetext>600 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBOXETINE</medicinalproduct>
        <drugdosagetext>8 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPIPRAMOL</medicinalproduct>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANYLCYPROMINE SULFATE</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130143-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2009RR-25165</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOROIDAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL DETACHMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugauthorizationnumb>076327</drugauthorizationnumb>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130144-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RANBAXY-2010RR-39709</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugauthorizationnumb>075944</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugdosagetext>0.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COGENTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130145-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10101494</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130146-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-CELGENEUS-013-21880-10112784</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100914</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIFROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130147-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RANBAXY-2010US-39640</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>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
        <drugauthorizationnumb>065007</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130148-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RANBAXY-2010US-39505</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>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugauthorizationnumb>019152</drugauthorizationnumb>
        <drugdosagetext>240 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>25 MG, BID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130149-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RANBAXY-2010US-36354</companynumb>
    <primarysource>
      <reportercountry>ALGERIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMAGNESAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugauthorizationnumb>019152</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAZOSIN</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANITUMUMAB</medicinalproduct>
        <drugdosagetext>UNK, 1 EVERY 2 WEEK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRINOTECAN</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130150-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RANBAXY-2010US-39578</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugauthorizationnumb>077327</drugauthorizationnumb>
        <drugdosagetext>2 MG/KG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130151-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-CELGENEUS-286-21880-10112706</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130152-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-CELGENEUS-144-21880-10112886</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>ANAEMIA HAEMOLYTIC AUTOIMMUNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELOFIBROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130153-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-CELGENEUS-082-21880-10112871</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</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>CUTANEOUS VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130154-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-JNJFOC-20101106234</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GOLIMUMAB</medicinalproduct>
        <drugadministrationroute>058</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>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130155-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RU-JNJFOC-20101107030</companynumb>
    <primarysource>
      <reportercountry>RUSSIAN FEDERATION</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALIGNANT MELANOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GOLIMUMAB</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GOLIMUMAB</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </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>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICHEW D3</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130156-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101105662</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>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130157-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101107090</companynumb>
    <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>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130158-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101100717</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>129.28</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>USTEKINUMAB</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>USTEKINUMAB</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130159-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20100906521</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100825</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130160-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10113047</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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130161-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-CELGENEUS-087-21880-10111728</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>BACTERIAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101113</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LENADEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUROTEP</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101113</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101113</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130162-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-CELGENEUS-008-21880-10112916</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>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090210</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130169-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KP-PAR PHARMACEUTICAL, INC-2010SCPR002307</companynumb>
    <primarysource>
      <reportercountry>KOREA, DEMOCRATIC PEOPLE'S REPUBLIC OF</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TOXIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugauthorizationnumb>018845</drugauthorizationnumb>
        <drugdosagetext>2 G, DAILY DOSAGE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BRAIN ABSCESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE</medicinalproduct>
        <drugdosagetext>8 G, DAILY DOSAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BRAIN ABSCESS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130176-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101120</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101108547</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>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130177-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101121</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20100209122</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE BEFORE PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL RESECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130178-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-US-EMD SERONO, INC.-7022850</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>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALLOPIAN TUBE ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101008</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130181-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101108237</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MULTIPLE CONGENITAL ABNORMALITIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEMASOLE</medicinalproduct>
        <drugauthorizationnumb>017481</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRON SUPPLEMENTS</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130182-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20090406716</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugauthorizationnumb>021346</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130183-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-JNJFOC-20101107600</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugdosagetext>HALF A PATCH APPLIED</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130184-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20101107925</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACQUIRED DIAPHRAGMATIC EVENTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIAPHRAGMATIC PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALLORY-WEISS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE STIMULATION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ CODEINE</medicinalproduct>
        <drugauthorizationnumb>085055</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130185-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13225BP</companynumb>
    <primarysource>
      <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>SPIRIVA</medicinalproduct>
        <drugbatchnumb>003817A,0D1002</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130186-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13212BP</companynumb>
    <primarysource>
      <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>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130187-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-KINGPHARMUSA00001-K201001390</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>65.76</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMBEDA</medicinalproduct>
        <drugauthorizationnumb>022321</drugauthorizationnumb>
        <drugdosagetext>20 MG, EVERY 12 HOURS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NECK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130188-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-GBRCT2010001963</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CERVIX CARCINOMA STAGE 0</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040515</drugenddate>
        <drugtreatmentduration>122</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130189-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20101108820</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130190-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20101108838</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC TAMPONADE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130191-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GENZYME-THYM-1002119</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugbatchnumb>C9054ND</drugbatchnumb>
        <drugdosagetext>137.5 MG, QD</drugdosagetext>
        <drugadministrationroute>042</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>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>APLASTIC ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100617</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODIOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHOLELITHOTOMY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100521</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECOBALAMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100520</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100617</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FILGRASTIM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>APLASTIC ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100613</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE SODIUM SUCCINATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <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>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100612</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100617</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED CELLS MAP</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLATELETS, CONCENTRATED</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100617</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130195-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-GBRCT2010001964</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>ETANERCEPT</medicinalproduct>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050314</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE SULFATE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETODOLAC</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130196-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-GBRCT2010001966</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>ETANERCEPT</medicinalproduct>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130197-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-GENZYME-THYM-1002115</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFOTAXIME SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROPOIETIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130199-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GENZYME-THYM-1002109</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>ACUTE HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS ASSOCIATED LYMPHOPROLIFERATIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STENOTROPHOMONAS SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>3.75 MG/KG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>APLASTIC ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100919</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE SODIUM SUCCINATE</medicinalproduct>
        <drugdosagetext>125 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101030</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSCARNET SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130200-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-CEPHALON-2010006178</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>APLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM DIFFICILE COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TREANDA</medicinalproduct>
        <drugauthorizationnumb>022249</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101011</drugenddate>
        <drugtreatmentduration>391</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130203-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENZYME-LEUP-1000008</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>COLON CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>075721</drugauthorizationnumb>
        <drugdosagetext>250 MCG, BID</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OVULATION INDUCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERGONAL</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OVULATION INDUCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHORIONIC GONADOTROPIN</medicinalproduct>
        <drugdosagetext>10000 U, UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>OVULATION INDUCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130204-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENZYME-FABR-1001671</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>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FABRAZYME</medicinalproduct>
        <drugbatchnumb>A0017A01,A0025A01</drugbatchnumb>
        <drugdosagetext>90 MG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FABRY'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101025</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130205-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GENZYME-CLOF-1001303</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR LYSIS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVOLTRA</medicinalproduct>
        <drugauthorizationnumb>021673</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101025</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130208-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AMGEN INC.-FRACT2010000653</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARBEPOETIN ALFA</medicinalproduct>
        <drugdosagetext>UNK UNK, Q2WK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090420</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCALTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KAYEXALATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENOTONORM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENAGEL                            /01459901/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENOFER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130210-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101108817</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPENDICECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130213-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-SOLVAY-00210007004</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 1.2 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100319</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 1.2 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 6 INTERNATIONAL UNIT(S)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 6 DOSAGE FORM</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 2 GRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100804</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAMICRON NOS</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERINDOPRIL</medicinalproduct>
        <drugauthorizationnumb>020184</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE: 8 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100804</drugenddate>
        <drugtreatmentduration>507</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100804</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130214-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SOLVAY-00210005817</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>15</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL TUBE INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL PH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT FLUCTUATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CREON</medicinalproduct>
        <drugbatchnumb>45792</drugbatchnumb>
        <drugauthorizationnumb>020725</drugauthorizationnumb>
        <drugdosagetext>CREON; DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CYSTIC FIBROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CREON</medicinalproduct>
        <drugauthorizationnumb>020725</drugauthorizationnumb>
        <drugdosagetext>CREON D.R,DAILY DOSE:15DOSAGE FORM,UNIT DOSE:12000LIPASE UNITS,3 CAPSULES WITH MEALS 3 TIMES/DAY, 2C</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMAX</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 2 MILLILITRE(S), FREQUENCY: DAILY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CYSTIC FIBROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMOZYME</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 1 VIAL</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CYSTIC FIBROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPERTONIC SALINE</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 1 VIAL</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CYSTIC FIBROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULFATE</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 1 VIAL</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CYSTIC FIBROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130216-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SOLVAY-00210006970</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>122.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANDRODERM</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN,</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANDROGEL</medicinalproduct>
        <drugauthorizationnumb>021015</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130218-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SOLVAY-00210007027</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>BRAIN NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANDROGEL</medicinalproduct>
        <drugauthorizationnumb>021015</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130222-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-JNJFOC-20101107630</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF INJURIOUS BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLUGGISHNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAVOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130223-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20100108245</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>202</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>202</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYSLEE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEAVY MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEAVY MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFOPERAZONE SODIUM AND SULBACTAM SODIUM</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLDEM 1</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130224-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101107924</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>61.24</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGAMENT RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130225-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101104826</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>MUSCLE RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENOSYNOVITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130226-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101108265</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53.52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130227-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20100804720</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>EPICONDYLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WHITE BLOOD CELL COUNT INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020635</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130228-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20101006402</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130229-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-JNJFOC-20101107625</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>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACCIDENTAL EXPOSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130230-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20101101345</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEVICE MALFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugbatchnumb>AFS5F;ACZXL00;ACSK000</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugbatchnumb>AFS5F;ACZXL00;ACSK000</drugbatchnumb>
        <drugauthorizationnumb>021346</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130231-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101107663</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>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYRINGE ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021346</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUPHENAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130232-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-JNJFOC-20101106838</companynumb>
    <primarysource>
      <reportercountry>FINLAND</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>BLOOD PROLACTIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALACTORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDIPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130233-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA78742</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRIGEMINAL NEURALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugdosagetext>9.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101114</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130234-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US79250</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL BONES FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUTURE INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5MG/YEAR</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130235-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2009CA51142</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080820</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130236-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2009US66772</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.492</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>500 MG, TID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091124</drugenddate>
        <drugtreatmentduration>57</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130237-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP15176</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>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND TREATMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugtreatmentduration>730</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI-CANCER DRUG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130238-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2009US00730</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>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS DRAINAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADRENAL NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANEURYSM REPAIR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOVENOUS FISTULA OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLEPHARITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON ADENOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDODONTIC PROCEDURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOCAL SEGMENTAL GLOMERULOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYRINGOTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ODYNOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS MEDIA CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FUNCTION TEST DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY NEUROPATHY HEREDITARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EROSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINE OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL LAMINECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBCUTANEOUS ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URGE INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR PSEUDOANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991130</drugenddate>
        <drugtreatmentduration>120</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>LIGHT CHAIN ANALYSIS INCREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPEUTICS NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN XL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENSIPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTOXIFYLLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLORINEF</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRENTAL ^ALBERT-ROUSSEL^</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MACROBID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDODRINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL PM, EXTRA STRENGTH</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDROCORTISONE ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORHEXIDINE GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130239-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR39834</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>BLOOD PROLACTIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DARK CIRCLES UNDER EYES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARLODEL</medicinalproduct>
        <drugauthorizationnumb>017962</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130240-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP76676</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DISODIUM INCADRONATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130241-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA81017</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100219</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130242-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP03518</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130243-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101120</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PAR PHARMACEUTICAL, INC-2010SCPR002310</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMODYNAMIC INSTABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPASE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugauthorizationnumb>075072</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHANOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE AND ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130246-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20101107684</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AGITATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugauthorizationnumb>015923</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTAZOLAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130247-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20101100316</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67</patientweight>
      <reaction>
        <reactionmeddrapt>CONTINUOUS HAEMODIAFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugdosagetext>350 DF</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZALIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130248-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101108039</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>EXPOSURE TO CONTAMINATED DEVICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY ASSOCIATED WITH DEVICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYRINGE ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugbatchnumb>181138;181138</drugbatchnumb>
        <drugauthorizationnumb>021346</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACCIDENTAL EXPOSURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130249-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20101108513</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHIATRIC SYMPTOM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020588</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130250-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-JNJFOC-20101100648</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugauthorizationnumb>020588</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE PSYCHOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAMYR</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130251-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006588</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>NPLATE</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNE GLOBULIN NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130252-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010FI78602</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED TENDENCY TO BRUISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRAUMATIC HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>020823</drugauthorizationnumb>
        <drugdosagetext>1 DF, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
        <drugtreatmentduration>1380</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICHEW-D3</medicinalproduct>
        <drugdosagetext>1 DF BID, (CALCIUM CARBONATE 500MG, CHOLECALCIFEROL 10 MICROGRAMS)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OBSIDAN FE++</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugdosagetext>1 DF, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEMANTINE HCL</medicinalproduct>
        <drugdosagetext>1 DF, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>1.5 DF DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVACOL</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFORMIN RETARD</medicinalproduct>
        <drugdosagetext>1 DF, BID</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130253-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US49292</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>EXTAVIA</medicinalproduct>
        <drugdosagetext>0.25 MG, QOD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100520</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130254-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US66462</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOBI</medicinalproduct>
        <drugauthorizationnumb>050753</drugauthorizationnumb>
        <drugdosagetext>300 MG, BID</drugdosagetext>
        <drugindication>CYSTIC FIBROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugdosagetext>3 TIMES A WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYCLINE</medicinalproduct>
        <drugdosagetext>100 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMOZYME</medicinalproduct>
        <drugindication>CYSTIC FIBROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130256-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20100706687</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>TENOSYNOVITIS STENOSANS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130257-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20100105523</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>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130258-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20100706834</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>EPICONDYLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130259-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101106070</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>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130260-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-JNJFOC-20101107949</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>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130261-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101108654</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53.52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENOPAUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT ADHESION ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>1003191P1</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FLUID RETENTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugdosagetext>7.5-325MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAKTHROUGH PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICYCLOMINE</medicinalproduct>
        <drugdosagetext>1 OR 2 CAPSULES A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130262-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101100804</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.31</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYASTHENIA GRAVIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT ADHESION ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>1003191P1</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130263-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101108048</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>ABNORMAL LOSS OF WEIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DIVERSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT PACKAGING QUANTITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOZ FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugdosagetext>100 UG/HR X 2</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOZ FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugbatchnumb>1000862</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugdosagetext>100 UG/HR X 2; NDC#: 0781-7244-55</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL AND ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>10/325</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIFUNGAL PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOL AND TRIMETHOPRIM</medicinalproduct>
        <drugdosagetext>800/160</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN SODIUM CAP</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130264-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010PL80247</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTAVIA</medicinalproduct>
        <drugdosagetext>250 UG/ML, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130265-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010FR80387</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>LIBIDO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE THOUGHTS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STALEVO 100</medicinalproduct>
        <drugauthorizationnumb>021485</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130267-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010004714</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EMBOLISM ARTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130268-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-ELI_LILLY_AND_COMPANY-PL201011005767</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NECITUMUMAB (11F8) (LY3012211)</medicinalproduct>
        <drugdosagetext>800 MG, UNK</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugdosagetext>2125 MG, UNK</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>128 MG, UNK</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVONOR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLONAMINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130269-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13199BP</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CATAPRES-TTS-1</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>018891</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130271-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101108607</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130272-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101108619</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>LUPUS-LIKE SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugdosagetext>THERAPY FOR 2 MONTHS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130274-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BE58256</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</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>HEMICEPHALALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG,</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130275-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US80874</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>RECLAST</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG, YEARLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130277-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR80653</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugbatchnumb>UNK.</drugbatchnumb>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG/100 ML, YEARLY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130278-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA64559</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL GRAFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091126</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130279-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA43363</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA EVACUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090710</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130280-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BE78630</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS TOXIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CURCUMA LONGA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100529</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERLAIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUROBION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN DETEMIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130281-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA65641</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091029</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130282-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US78351</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>40.816</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STUPOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugdosagetext>1 PATCH ON EVERY WEEK OR EVERY 6 DAYS</drugdosagetext>
        <drugindication>DEMENTIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIDEPRESSANTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130283-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR80652</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>ACLASTA</medicinalproduct>
        <drugbatchnumb>UNK.</drugbatchnumb>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG/100 ML, YEARLY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130285-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PE-PFIZER INC-2010156889</companynumb>
    <primarysource>
      <reportercountry>PERU</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>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DETRUSITOL</medicinalproduct>
        <drugauthorizationnumb>020771</drugauthorizationnumb>
        <drugdosagetext>2 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTONIC BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101118</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130286-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2010161020</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GESTATIONAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugauthorizationnumb>011459</drugauthorizationnumb>
        <drugdosagetext>25 MG, AT EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130287-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010063169</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>1.729</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugbatchnumb>OA1SU; OA4UD; OA5P8</drugbatchnumb>
        <drugauthorizationnumb>020246</drugauthorizationnumb>
        <drugdosagetext>150 MG, EVERY 11-13 WEEKS</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100420</drugenddate>
        <drugtreatmentduration>169</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130288-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2010156607</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>80 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101024</drugenddate>
        <drugtreatmentduration>68</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL</medicinalproduct>
        <drugdosagetext>1.25 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL</medicinalproduct>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>80 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugdosagetext>90 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130289-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010063148</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY WITH INJECTABLE CONTRACEPTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE LABOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE RUPTURE OF MEMBRANES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNINTENDED PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugbatchnumb>OA1SU; OA4UD; OA5P8</drugbatchnumb>
        <drugauthorizationnumb>020246</drugauthorizationnumb>
        <drugdosagetext>150 MG, EVERY 11-13 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100420</drugenddate>
        <drugtreatmentduration>169</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>020246</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091103</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130290-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006615</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>PROCRIT</medicinalproduct>
        <drugdosagetext>20000 IU, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130293-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010DE60855</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL TUBE INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND TREATMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>ONCE MONTHLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>QUARTERLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100927</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130294-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA80732</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100224</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130295-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010FR80285</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHTHOUS STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONCOMITANT DISEASE AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIASCLEDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130296-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA79874</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130297-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA80697</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100208</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130298-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2009CA21398</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>BLOOD GLUCOSE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JUGULAR VEIN DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEPTIC ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>NEUROENDOCRINE CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>30 MG, EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CARCINOID SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080115</drugstartdate>
      </drug>
      <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>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>30 MG, BIW</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130299-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010MX80326</companynumb>
    <primarysource>
      <reportercountry>MEXICO</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>HEPATIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG/100 ML, ONCE YEARLY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130300-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-AMGEN-CANSP2010006268</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130301-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060227</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2006NL02717</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130302-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-TYCO HEALTHCARE/MALLINCKRODT-T201002228</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>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIRAY 350</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019710</drugauthorizationnumb>
        <drugdosagetext>75 ML, SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>UROGRAM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130303-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-TYCO HEALTHCARE/MALLINCKRODT-T201002325</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>100</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIRAY 350</medicinalproduct>
        <drugbatchnumb>V103C</drugbatchnumb>
        <drugauthorizationnumb>019710</drugauthorizationnumb>
        <drugdosagetext>100 ML, SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COMPUTERISED TOMOGRAM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130304-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-TYCO HEALTHCARE/MALLINCKRODT-T201002190</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIMARK</medicinalproduct>
        <drugbatchnumb>V149D</drugbatchnumb>
        <drugauthorizationnumb>020937</drugauthorizationnumb>
        <drugdosagetext>10 ML, SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101011</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130309-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010NL77635</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FACIAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugbatchnumb>S0240</drugbatchnumb>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4MG/5ML PER 28 DAYS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090526</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugbatchnumb>S0240</drugbatchnumb>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4MG/5ML PER 28 DAYS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugbatchnumb>S0240</drugbatchnumb>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4MG/5ML PER 28 DAYS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130311-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20101004354</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NON STEROIDAL ANTI-INFLAMMATORY DRUGS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130312-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SHIRE-SPV1-2010-01589</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSRENOL</medicinalproduct>
        <drugauthorizationnumb>021468</drugauthorizationnumb>
        <drugdosagetext>UNK, TOTAL DAILY DOSE OF 1500 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100831</drugenddate>
        <drugtreatmentduration>194</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRINAZIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTCILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOVIRAX                            /00587301/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTIST</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONIEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEROFF</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLARAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILLIS</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOSENN                            /00476901/</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDE                          /00571901/</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINORIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITANEURIN                         /00056102/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RINDERON                           /00008501/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130313-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ASTRAZENECA-2010SE54052</companynumb>
    <primarysource>
      <reportercountry>CHINA</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>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101111</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101111</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130314-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2010SE56195</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>98</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAT ILLNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ECARD COMBINATION TABLETS HD</medicinalproduct>
        <drugauthorizationnumb>021093</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100727</drugenddate>
        <drugtreatmentduration>94</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100727</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEZATATE SR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100727</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPIDIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100727</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100727</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID FLEXPEN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130315-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HU-AMGEN-HUNSP2010003489</companynumb>
    <primarysource>
      <reportercountry>HUNGARY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>APLASIA PURE RED CELL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>1022211</drugbatchnumb>
        <drugdosagetext>50 A?G, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100408</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERRLECIT                          /01099901/</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>3 MG, QWK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100408</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMID                          /00032601/</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OLIGURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100408</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONTROLOC                          /01263201/</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAPREL MR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130316-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13318BP</companynumb>
    <primarysource>
      <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>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130317-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010IL16347</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>46.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CENTRAL NERVOUS SYSTEM LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBELLAR SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLOUR BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSMETROPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIANOPIA HOMONYMOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METAMORPHOPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASTICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYRAMIDAL TRACT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE BITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONIC CLONIC MOVEMENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FTY 720 FTY+CAP+MSC</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>DOSE BLINDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100308</drugenddate>
        <drugtreatmentduration>252</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FTY 720 FTY+CAP+MSC</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101026</drugenddate>
        <drugtreatmentduration>232</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MUSCLE SPASTICITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101026</drugenddate>
        <drugtreatmentduration>645</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101025</drugenddate>
        <drugtreatmentduration>487</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRALEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MODAFINIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>FATIGUE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090324</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090311</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130318-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ABBOTT-10P-114-0687351-00</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL RESECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVONORGESTREL + ETHINYL ESTRADIOL</medicinalproduct>
        <drugdosagetext>100MCG/20</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130319-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-10P-062-0687199-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100712</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130320-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-10P-020-0687680-00</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR GRAFT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130323-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060301</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2006NL02718</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130325-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060418</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2006NL02720</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130326-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2010SE56201</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9041</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPRIVAN</medicinalproduct>
        <drugauthorizationnumb>019627</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUFENTA PRESERVATIVE FREE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFAZOLIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100629</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130327-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BAXTER-2010BH025317</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD LIQUID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OPPORTUNISTIC INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100416</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD LIQUID</medicinalproduct>
        <drugbatchnumb>LE12J236AJ</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD LIQUID</medicinalproduct>
        <drugbatchnumb>LE12J360AG</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD LIQUID</medicinalproduct>
        <drugbatchnumb>LE12J225AP</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAVELBINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HODGKIN'S DISEASE STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAVELBINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OFF LABEL USE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HODGKIN'S DISEASE STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLUPRED</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100518</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMEND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPHREN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORACILLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130328-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA064290</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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100520</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100923</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED THERAPY</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130332-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-GBRCT2010001967</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUAZIDE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN WITH PROPOXYPHENE HCL TAB</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAVISCON</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPROMELLOSE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS GLUCONATE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130333-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-PAR PHARMACEUTICAL, INC-2010SCPR002306</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPRANOLOL HCL</medicinalproduct>
        <drugauthorizationnumb>071288</drugauthorizationnumb>
        <drugdosagetext>80 MG, SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130334-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101013</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010EC77939</companynumb>
    <primarysource>
      <reportercountry>ECUADOR</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLON CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130335-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2009JP38506</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEM CELL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR LYSIS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090902</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSAID'S</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERNELIN</medicinalproduct>
        <drugdosagetext>3 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDE</medicinalproduct>
        <drugdosagetext>24 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXINORM</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugdosagetext>990 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVAMIN</medicinalproduct>
        <drugdosagetext>15 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090924</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130340-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2010143365</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</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>CEREBRAL HAEMORRHAGE</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>7130341-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2010143317</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>INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>80 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130342-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010132223</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>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY SLEEP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130343-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2010143342</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</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>INFARCTION</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>20090807</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130344-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010085970</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>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <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>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DITROPAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTONIC BLADDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>EYE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPTIVE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>EYE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONTELUKAST</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>81 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugdosagetext>100 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>1 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUMIGAN</medicinalproduct>
        <drugdosagetext>3.5 MG, UNK</drugdosagetext>
        <drugindication>EYE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>300 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDODRINE</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugdosagetext>70 MG, WEEKLY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>UNK, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugdosagetext>500 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITRUCEL</medicinalproduct>
        <drugdosagetext>8 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130345-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2008US11463</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOVENOUS FISTULA OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER PLACEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRANIOTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE RELATED SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS EROSIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOSPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPARATHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPHOSPHATAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERCOSTAL NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBOSACRAL PLEXUS LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELOMA RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOFASCIAL PAIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHYSICAL DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIATION INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIATION NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOULDER DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH IMPACTED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URETERAL STENT INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTEBROPLASTY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>90 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050518</drugenddate>
        <drugtreatmentduration>113</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT                            /00909301/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENSIPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN ^LAPPE^</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANZEMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOXI</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KENALOG</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugdosagetext>10 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
        <drugdosagetext>4 MG, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL AND ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>10/325 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
        <drugdosagetext>3 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFEPIME</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORADOL</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENA-VITE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMINYL</medicinalproduct>
        <drugdosagetext>800 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>PRN AT NIGHT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130346-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US78723</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>GLEEVEC</medicinalproduct>
        <drugbatchnumb>F0119</drugbatchnumb>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE</medicinalproduct>
        <drugdosagetext>100 MG, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM GLUTAMATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</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>LOVASTATIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130347-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010ZA24281</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>EYE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100415</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130348-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2009US09113</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLEPHARITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY BYPASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTATIC MALIGNANT MELANOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE STRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOLOGICAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIODONTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN NEOPLASM EXCISION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TROPONIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 1 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAPTOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130349-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-AVENTIS-2010SA012042</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HISTIOCYTOSIS HAEMATOPHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROTISING OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugbatchnumb>U</drugbatchnumb>
        <drugauthorizationnumb>020905</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090415</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APRANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090415</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ PROPOXYPHENE HCL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOPRAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRETERAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130351-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-GBRCT2010002408</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>TONGUE CARCINOMA STAGE I</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050819</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130352-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-GBRCT2010002613</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE PHOSPHATE/PARACETAMOL</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE SULFATE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130353-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-GBRCT2010002098</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-DYDRAMOL</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130354-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AMGEN-QUU433964</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <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>20051228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>15MG (FREQUENCY UNKNOWN)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOCORTICOIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130355-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US70368</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>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>Q 3 MONTHS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>POST GASTRIC SURGERY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE</medicinalproduct>
        <drugdosagetext>30 MG Q6W PM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE</medicinalproduct>
        <drugdosagetext>100 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugdosagetext>PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIVALPROEX SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>1 MG, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAIULLIDUE</medicinalproduct>
        <drugdosagetext>150 MG, BID</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130356-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CO80733</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</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>RASILEZ</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>300 MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEBIVOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINTREPID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVAS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130357-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010MX80935</companynumb>
    <primarysource>
      <reportercountry>MEXICO</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>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>320 MG, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXFORGE</medicinalproduct>
        <drugdosagetext>160/5 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130358-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US79023</companynumb>
    <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>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130359-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010DE80435</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>
      <patientweight>89</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXFORGE HCT</medicinalproduct>
        <drugauthorizationnumb>022314</drugauthorizationnumb>
        <drugdosagetext>ONE TABLET DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100929</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XENETIX</medicinalproduct>
        <drugdosagetext>100 ML (76780 MG)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ARTERIOGRAM CORONARY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100924</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130360-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA80716</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091215</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130361-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP78216</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>ACUTE CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>160MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTIST</medicinalproduct>
        <drugdosagetext>10MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugdosagetext>200MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGLAX</medicinalproduct>
        <drugdosagetext>660MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>2.5MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPADEL</medicinalproduct>
        <drugdosagetext>1200MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130362-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-SANOFI-AVENTIS-2010SA066316</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFLIBERCEPT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFLIBERCEPT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETADINE ^PURDUE^</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TANTUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100625</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGESTROL ACETATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100816</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100927</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130363-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101120</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101108542</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BEHCET'S SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLU-CORTEF</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STATEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130364-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-10P-028-0687355-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL RESECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>80MG AT WEEK 2</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130367-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AMGEN-QUU444443</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NASAL POLYPS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100806</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUTHYROX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130372-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-SANOFI-AVENTIS-2010SA071362</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFLIBERCEPT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFLIBERCEPT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETADINE ^PURDUE^</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TANTUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGESTROL ACETATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100816</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100927</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130373-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-GENZYME-CAMP-1001154</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAMPATH</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>12 MG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101015</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130377-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011005599</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>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130379-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200906003150</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A546083C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130380-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011005230</companynumb>
    <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>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A591127C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130381-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011004365</companynumb>
    <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>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A670122C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLESTYRAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130382-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201010005656</companynumb>
    <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 INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130383-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201010003979</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</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>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A638543C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101008</drugenddate>
        <drugtreatmentduration>61</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RELAFIN</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>CALCIUM</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZILACTIN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVENTIL /00139502/</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130384-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201007005846</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>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE FORMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ITCHING SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIITH NERVE PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A709637C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100505</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A713107C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A560797C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A728052C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>200 MG, 3/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugdosagetext>150 MG, 3/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugdosagetext>UNK, 3/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>500 MG, 4/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>800 MG, 4/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>150 MG, EACH MORNING (3 AT ONES)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
        <drugdosagetext>10/650MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN                                /SCH/</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130385-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100928</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2009US11130</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>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE FRACTURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK, ONCE/SINGLE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK, ONCE/SINGLE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100813</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130386-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BAXTER-2010BH026761</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>ANTI-ERYTHROCYTE ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD LIQUID</medicinalproduct>
        <drugbatchnumb>LE12K060AM</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>POLYNEUROPATHY CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD LIQUID</medicinalproduct>
        <drugbatchnumb>LE12K060AM</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OFF LABEL USE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD LIQUID</medicinalproduct>
        <drugbatchnumb>LE12K011AC</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD LIQUID</medicinalproduct>
        <drugbatchnumb>LE12K011AC</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD LIQUID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD LIQUID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130387-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP62346</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUTRITIONAL CONDITION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>80 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
        <drugdosagetext>2 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM ANTAGONIST</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130388-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010DE79776</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CGS 20267 T30748+</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugdosagetext>2.5 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>25 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOTUM</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130389-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2010GB05457</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>ABNORMAL BEHAVIOUR</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>20100217</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130390-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US78219</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INADEQUATELY CONTROLLED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugbatchnumb>F0884</drugbatchnumb>
        <drugdosagetext>160 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKELAXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130391-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2010IE05043</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LAPAROSCOPY</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>20080220</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130392-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13306BP</companynumb>
    <primarysource>
      <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>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METACAM ORAL SUSPENSION</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021530</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101117</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130393-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13342BP</companynumb>
    <primarysource>
      <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>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130394-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA75875</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCORIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLIATIVE CARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TERMINAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>30 MG ONCE A MONTH</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SUBILEUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100521</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130395-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP75659</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugauthorizationnumb>017963</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>060</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130396-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR78688</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>DIOVAN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>160 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130397-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2009CA42878</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>50 MG EVERY 3 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>VIPOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>50 MG EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>50 MG, TIW</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130398-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA58862</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <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>20031001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130403-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010FR13677</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>34.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR EXCISION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONATE T29581+SOLINJ+BM</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091016</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100628</drugenddate>
        <drugtreatmentduration>260</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VP-16</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100419</drugenddate>
        <drugtreatmentduration>169</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100531</drugenddate>
        <drugtreatmentduration>211</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091017</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090415</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PARAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARDEGIC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100209</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130404-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA00660</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED INTRAABDOMINAL FLUID COLLECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARACENTESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROIDECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>40 MG ONCE A MONTH</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>NEUROENDOCRINE TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091203</drugstartdate>
      </drug>
      <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>60 MG, UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100726</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130405-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2008CA25639</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>AORTIC ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC PACEMAKER INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOSCOPY UPPER GASTROINTESTINAL TRACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED UPPER AIRWAY SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENIERE'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN ENLARGEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>10 MG EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>GASTRIC MUCOSAL HYPERTROPHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100304</drugenddate>
        <drugtreatmentduration>584</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <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>10 MG EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>10 MG, QMO</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugdosagetext>35 MG, QW</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>1.5 TABS, 7.5 MG DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>1.5 DF DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130406-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA71523</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAL FISSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>60 MG EVERY 2 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CARCINOID TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040909</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130407-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2010143371</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</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>DIABETIC COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130409-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2010143390</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</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>LEUKAEMIA</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>7130410-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2010144623</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>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130411-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2010144293</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130412-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-AVENTIS-2010SA071766</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>CELL DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA MUCOSAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFADIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>050420</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SEPTIC ARTHRITIS STAPHYLOCOCCAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091104</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SEPTIC ARTHRITIS STAPHYLOCOCCAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091104</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130413-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NAPPMUNDI-USA-2010-0055668</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INADEQUATE ANALGESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>WAD31</drugbatchnumb>
        <drugauthorizationnumb>022272</drugauthorizationnumb>
        <drugdosagetext>80 MG, Q12H</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130414-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2010SE45631</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28028</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100920</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100920</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100920</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100920</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT B12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAX SEED</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GINKO BALOBA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE</medicinalproduct>
        <drugdosagetext>1-2 TABS HS</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130415-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA-2010-0047018</companynumb>
    <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>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022272</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130416-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA042253</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>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNDERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTAQ</medicinalproduct>
        <drugbatchnumb>AJ62</drugbatchnumb>
        <drugauthorizationnumb>022425</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTAQ</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022425</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130417-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101108591</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130418-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20100907768</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>ORMA63201</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>ORMA63201</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130423-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NAPPMUNDI-USA-2010-0047071</companynumb>
    <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>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022272</drugauthorizationnumb>
        <drugdosagetext>160 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130424-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2010SE56232</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>VANISHING BILE DUCT SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAL</medicinalproduct>
        <drugauthorizationnumb>019810</drugauthorizationnumb>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080327</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAXOBERON</medicinalproduct>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080327</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAURINE</medicinalproduct>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080327</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130425-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2010SE56115</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31726</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYTACAND</medicinalproduct>
        <drugauthorizationnumb>021093</drugauthorizationnumb>
        <drugdosagetext>8/12.5MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100722</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MONO TILDIEM CR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100505</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MONO TILDIEM CR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASTAREL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100722</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OGASTRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130426-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100423</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ASTRAZENECA-2010SE16670</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>019810</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100326</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>EALES' DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUSOPT</medicinalproduct>
        <drugdosagetext>ONCE A DAY</drugdosagetext>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOLOL MALEATE</medicinalproduct>
        <drugdosagetext>ONCE DAILY</drugdosagetext>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LATANOPROST</medicinalproduct>
        <drugdosagetext>ONCE DAILY</drugdosagetext>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICHEW D3</medicinalproduct>
        <drugdosagetext>ONCE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130427-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA-2010-0052579</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 GRAFT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>120 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130428-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-FRASP2010004880</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPARATHYROIDISM SECONDARY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130429-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ABBOTT-10P-083-0682948-00</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLACID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOOTH EXTRACTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADONE HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG DEPENDENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FIDATO</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>TOOTH EXTRACTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101026</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130430-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA064574</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>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROSACEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTAQ</medicinalproduct>
        <drugbatchnumb>BF19</drugbatchnumb>
        <drugauthorizationnumb>022425</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTAQ</medicinalproduct>
        <drugbatchnumb>BF19</drugbatchnumb>
        <drugauthorizationnumb>022425</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130431-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-MPIJNJ-2010-05936</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIAC ENZYMES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021602</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130432-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MPIJNJ-2010-05913</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR LYSIS SYNDROME</reactionmeddrapt>
      </reaction>
      <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>20101108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101108</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130433-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NAPPMUNDI-USA-2010-0055179</companynumb>
    <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>SPINAL CORD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>WAD01</drugbatchnumb>
        <drugauthorizationnumb>022272</drugauthorizationnumb>
        <drugdosagetext>80 MG, TWICE</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100915</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130436-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-FRASP2010004884</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPARATHYROIDISM SECONDARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130438-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-FRASP2010004885</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPARATHYROIDISM SECONDARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130439-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-AVENTIS-2010SA052031</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OESOPHAGEAL CARCINOMA RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEDAPLATIN</medicinalproduct>
        <drugindication>OESOPHAGEAL CARCINOMA RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130440-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA071481</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>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIPRASIDONE MESILATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE STOPPED IN JULYL (YEAR NOT PROVIDED)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETYL SALICYLIC ACID USP BAT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNESIUM HYDROXIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130441-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ALEXION PHARMACEUTICALS INC.-A201001520</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIRIS</medicinalproduct>
        <drugdosagetext>600 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HAEMOLYTIC URAEMIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABETALOL HCL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN A</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROPOIETIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130442-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ALEXION-A201001290</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>COPPER DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS EROSIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIRIS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAROXYSMAL NOCTURNAL HAEMOGLOBINURIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIRIS</medicinalproduct>
        <drugdosagetext>900 MG, Q12D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIRIS</medicinalproduct>
        <drugdosagetext>900 MG, QW</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080910</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIRIS</medicinalproduct>
        <drugdosagetext>1200 MG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080924</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B12                        /00056201/</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL DISCOMFORT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130443-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA066096</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULAR FILTRATION RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTAQ</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022425</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FLUTTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTACIDS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARAFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM SILVER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINITRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KAON CL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130445-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHIRE-ALL1-2010-06195</companynumb>
    <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>FOSRENOL</medicinalproduct>
        <drugauthorizationnumb>021468</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101026</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130446-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101107245</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>1.88</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SMALL FOR DATES BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTELENCE</medicinalproduct>
        <drugauthorizationnumb>022187</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTELENCE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130447-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ALLERGAN-1014013US</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>BLINDNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIGAN</medicinalproduct>
        <drugauthorizationnumb>021398</drugauthorizationnumb>
        <drugdosagetext>1 GTT, QD</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
        <drugtreatmentduration>213</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUMIGAN</medicinalproduct>
        <drugdosagetext>1 GTT, QD</drugdosagetext>
        <drugindication>GLAUCOMA</drugindication>
        <drugtreatmentduration>213</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZOPT</medicinalproduct>
        <drugdosagetext>1 GTT, BID</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
        <drugtreatmentduration>213</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130451-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA039131</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>115.91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNAMBULISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPHENIDATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUMATRIPTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT CC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE</medicinalproduct>
        <drugindication>BACK INJURY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
        <drugindication>BACK INJURY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMIPRAMINE</medicinalproduct>
        <drugindication>BACK INJURY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugindication>BACK INJURY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASAL SPRAY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130452-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-AVENTIS-2010SA069941</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>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTAQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>022425</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LODOZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERSYL /FRA/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130453-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA040012</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>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>AB48H/8V004</drugbatchnumb>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugdosagetext>SPLIT TABLETS TAKING ONE THIRD OF THE TABLET AT A TIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARMOUR THYROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130454-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-AVENTIS-2010SA058262</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYSLEE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090202</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOLEDOMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090202</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEILAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130455-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101105381</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>122.47</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTERED AT INAPPROPRIATE SITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION DURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0919339</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130456-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101107647</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT ADHESION ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugdosagetext>NDC NUMBER: 50458-0090-05</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE</medicinalproduct>
        <drugdosagetext>4 TIMES A DAY AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAKTHROUGH PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130457-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101002863</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUBDURAL EMPYEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130458-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101108070</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130461-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJCH-2010027143</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILD ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PSEUDOEPHEDRINE HCL</medicinalproduct>
        <drugdosagetext>TEXT:UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>TEXT:UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130462-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>AU-JNJFOC-20101104436</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAKTHROUGH PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>UNKNOWN BATCH</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugdosagetext>EVERY 2 DAYS</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130463-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20100707914</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>COLITIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAELYX</medicinalproduct>
        <drugdosagetext>CYCLE 7</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>KAPOSI'S SARCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAELYX</medicinalproduct>
        <drugdosagetext>CYCLE 6</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAELYX</medicinalproduct>
        <drugdosagetext>CYCLE 5</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAELYX</medicinalproduct>
        <drugdosagetext>CYCLE 4</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAELYX</medicinalproduct>
        <drugdosagetext>CYCLE 3</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAELYX</medicinalproduct>
        <drugdosagetext>CYCLE 2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAELYX</medicinalproduct>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugdosagetext>CYCLE 1</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERSYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUPRESSYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XATRAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOMIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPASFON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPEGIC 1000</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130464-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20100703635</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>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130465-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US78729</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>HEPATIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130466-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP78344</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYPEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NU-LOTAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130467-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA75065</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>212.5</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101104</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>250 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAVOTRIL</medicinalproduct>
        <drugdosagetext>01 MG, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130468-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010AU71263</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECHOCARDIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT ELEVATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST CHOLECYSTECTOMY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TROPONIN I INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100910</drugenddate>
        <drugtreatmentduration>70</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugdosagetext>10 MG MANE AND 30 MG NOCTE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMISULPRIDE</medicinalproduct>
        <drugdosagetext>300 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>10 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZTROPINE MESYLATE</medicinalproduct>
        <drugdosagetext>01 MG, BID</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130469-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010AT78553</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>98</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugdosagetext>160/25 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTACOR</medicinalproduct>
        <drugdosagetext>160 MG DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130470-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010ES78058</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TACHYARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>160 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100805</drugenddate>
        <drugtreatmentduration>52</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130471-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010FR54607</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOSPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSPLENISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEPONEX</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100816</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130472-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR28982</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN B12 INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>1 TABLET IN THE MORNING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>1 CAPSULE IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMALGIN</medicinalproduct>
        <drugdosagetext>1 TABLET AFTER THE LUNCH</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130473-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR28049</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR GRAFT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>1 TABLET PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100329</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130474-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010AU77800</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>500 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100805</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANADOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130475-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR27142</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>80 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130476-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP72348</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE COLOUR ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RASILEZ</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>150 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLORIC ^FRESENIUS^</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMETEC</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
        <drugdosagetext>03 G, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZELASTINE HCL</medicinalproduct>
        <drugdosagetext>16 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugdosagetext>0.2 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOLONG</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NATEGLINIDE</medicinalproduct>
        <drugdosagetext>90 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PELEX</medicinalproduct>
        <drugdosagetext>03 G, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAFFEINE ^HOUDE^</medicinalproduct>
        <drugdosagetext>0.035 G, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONTOL</medicinalproduct>
        <drugdosagetext>0.05 G, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>0.6 G, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROBAXIN</medicinalproduct>
        <drugdosagetext>0.25 G, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130477-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR78068</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>160 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>320 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130478-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR27151</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 INADEQUATELY CONTROLLED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FURUNCLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RASILEZ</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130479-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US78829</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130480-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US79154</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>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTURNA</medicinalproduct>
        <drugauthorizationnumb>022217</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130481-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR29406</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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>1 TABLET/ TWICE A DAY (MORNING AND NIGHT).</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANGIPRESS</medicinalproduct>
        <drugdosagetext>1 TABLET/TWICE A DAY</drugdosagetext>
        <drugindication>TACHYCARDIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VETRION</medicinalproduct>
        <drugdosagetext>1 VAGINAL APPLICATION A WEEK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENALFAN PLUS</medicinalproduct>
        <drugdosagetext>1 TABLET/TWICE A DAY</drugdosagetext>
        <drugindication>STRESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETSIM</medicinalproduct>
        <drugdosagetext>1 TABLET AT NIGHT</drugdosagetext>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOOTRON</medicinalproduct>
        <drugdosagetext>1 TABLET AT NIGHT</drugdosagetext>
        <drugindication>FATIGUE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130482-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR27311</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>
      <patientweight>82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RASILEZ</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130483-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR78656</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 INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXFORGE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021990</drugauthorizationnumb>
        <drugdosagetext>320/5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130484-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US78864</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TASIGNA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130485-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR29003</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXFORGE</medicinalproduct>
        <drugauthorizationnumb>021990</drugauthorizationnumb>
        <drugdosagetext>320/5 MG,UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RASILEZ (ALISKIREN)</medicinalproduct>
        <drugdosagetext>300 MG,UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130486-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR28996</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>80 MG,UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>160 MG,UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130487-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010FR75234</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSEUDOLYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NISISCO</medicinalproduct>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19430324</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130488-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR29443</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR GRAFT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>160 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130489-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP61586</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>160 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>10 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPLERENONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugindication>BLOOD PRESSURE MANAGEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130490-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-AVENTIS-2010SA035031</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>
      <patientweight>69.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE LEAKAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KETOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITANGO PEN</medicinalproduct>
        <drugbatchnumb>C081</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>9L004A/41C109</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE:10 UNIT(S)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040510</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugdosagetext>10-8-10 UNITS/DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040510</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130491-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA55539</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>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>400 MG</drugdosagetext>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100811</drugenddate>
        <drugtreatmentduration>2641</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIVAL</medicinalproduct>
        <drugdosagetext>100 MG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIVAL</medicinalproduct>
        <drugdosagetext>500</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
        <drugdosagetext>40 MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
        <drugdosagetext>40 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>5 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>5 MG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugdosagetext>40 MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>0.5 MG DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>5 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TECTA</medicinalproduct>
        <drugdosagetext>40</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROPEUN</medicinalproduct>
        <drugdosagetext>81 MG, OD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130492-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA070108</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.42</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</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>20100401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTAQ</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022425</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTAQ</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022425</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101017</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUMIGAN</medicinalproduct>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130493-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-BRISTOL-MYERS SQUIBB COMPANY-15213267</companynumb>
    <primarysource>
      <reportercountry>DENMARK</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>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>TABS</drugdosagetext>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>20MG COATED TABS</drugdosagetext>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091104</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130494-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-15358526</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>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPRYCEL</medicinalproduct>
        <drugbatchnumb>0D58316</drugbatchnumb>
        <drugauthorizationnumb>021986</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100909</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALORON N</medicinalproduct>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>1DF= 40 (UNITS NOT SPECIFIED).</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130497-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101108272</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>47.63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugbatchnumb>9LM6671P1</drugbatchnumb>
        <drugauthorizationnumb>021180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130498-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20061004265</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>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130499-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-JNJFOC-20101107654</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</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>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugauthorizationnumb>021346</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130500-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101108071</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADDISON'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNE SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugauthorizationnumb>021121</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130501-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-15406564</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>ERYSIPELAS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICOSE ULCERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugauthorizationnumb>009218</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>TRIATEC</medicinalproduct>
        <drugdosagetext>ADMINISTERED FROM PAST 10 YEARS.</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>SECTRAL</medicinalproduct>
        <drugdosagetext>ADMINISTERED FROM PAST 10 YEARS.</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>PHYSIOTENS</medicinalproduct>
        <drugdosagetext>ADMINISTERED FROM PAST 10 YEARS.</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>RASILEZ HCT</medicinalproduct>
        <drugdosagetext>ADMINISTERED FROM PAST 10 YEARS.</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>NITRODERM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>FLECAINIDE ACETATE</medicinalproduct>
        <drugdosagetext>1 DF=200 PROLONGED RELEASE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130502-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-10P-028-0687829-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC PACEMAKER INSERTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAVIK</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020528</drugauthorizationnumb>
        <drugdosagetext>2 MG/DAY</drugdosagetext>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>25 MG/DAY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130503-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-15408115</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugauthorizationnumb>020262</drugauthorizationnumb>
        <drugdosagetext>AND ON 07-OCT-2010</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugauthorizationnumb>019880</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>STRENGHT:150MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPHREN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZANTAC</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLARAMINE</medicinalproduct>
        <drugdosagetext>AND UNKNOWN ROUTE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMEND</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYZAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130504-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-14394217</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>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080814</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>1 DOSAGE FORM = 6MG/ML/MIN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080814</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL SULFATE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIGRAN</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN-ZINC TANNATE COMPLEX</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHROMIUM PICOLINATE</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GELCLAIR</medicinalproduct>
        <drugdosagetext>1 DF=5 PM</drugdosagetext>
        <drugindication>MUCOSAL INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080818</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugdosagetext>1 DF=750 NO UNITS:2SEP-2SEP08 500MG:4SEP-4SEP08,2SEP-12SEP08 TD:10DAYS</drugdosagetext>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081103</drugenddate>
        <drugtreatmentduration>59</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080909</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCET</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080812</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081103</drugenddate>
        <drugtreatmentduration>62</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080904</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130505-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-BRISTOL-MYERS SQUIBB COMPANY-15410582</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>
      <patientweight>64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>STRENGTH:5MG/ML RECENT INF(10TH):15NOV10</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEAD AND NECK CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101115</drugenddate>
        <drugtreatmentduration>70</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>RECENT INF(4TH):15NOV10</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEAD AND NECK CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101115</drugenddate>
        <drugtreatmentduration>70</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>CONTINUOUS INF FROM DAY 1 TO DAY 4 OF CYCLE RECENT INF(4TH):15NOV10</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEAD AND NECK CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101115</drugenddate>
        <drugtreatmentduration>70</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130506-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-15409717</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130507-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-15409592</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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 DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZODIAZEPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130508-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MY-BRISTOL-MYERS SQUIBB COMPANY-15412935</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugauthorizationnumb>021360</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIRETROVIRAL THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130509-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-AP-00518AP</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>122.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugauthorizationnumb>063267</drugauthorizationnumb>
        <drugdosagetext>220 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugdosagetext>750 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELOKEN</medicinalproduct>
        <drugdosagetext>95 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</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>AMARYL</medicinalproduct>
        <drugdosagetext>12 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugdosagetext>80 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIABETEX</medicinalproduct>
        <drugdosagetext>3000 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEFZOL</medicinalproduct>
        <drugdosagetext>6 G</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>600 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAIN PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugdosagetext>8 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVALGIN</medicinalproduct>
        <drugdosagetext>4 G</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAIN PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130510-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13313BP</companynumb>
    <primarysource>
      <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>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <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>20101024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC PH DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130511-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-UK-01133UK</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130512-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13369BP</companynumb>
    <primarysource>
      <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>SPIRIVA</medicinalproduct>
        <drugbatchnumb>909249A</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>909249A</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130513-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-12948NB</companynumb>
    <primarysource>
      <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>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130514-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20101200076</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PALEXIA RETARD</medicinalproduct>
        <drugauthorizationnumb>022304</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130515-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20061100529</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130516-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101108088</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</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>7130517-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-AVENTIS-2010SA070153</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>TAXOTERE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130521-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-AVENTIS-2010SA071212</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>AZOTAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTAQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>022425</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101029</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101029</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINTROM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ART</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERY-TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130522-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-AVENTIS-2010SA070537</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>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION SUSCEPTIBILITY INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PERCUTANEOUS CORONARY INTERVENTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CORONARY ARTERY STENOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAGNOSTIC AGENTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130523-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA047288</companynumb>
    <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 BREAKAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE MALFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT PRODUCT STORAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEEDLE ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLOSTAR</medicinalproduct>
        <drugbatchnumb>C783</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>C783</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130527-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MYLANLABS-2010S1018232</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>87.91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADNEXA UTERI MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugauthorizationnumb>075640</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090729</drugenddate>
        <drugtreatmentduration>97</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugauthorizationnumb>075640</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090909</drugenddate>
        <drugtreatmentduration>97</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugauthorizationnumb>075640</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090923</drugenddate>
        <drugtreatmentduration>97</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090923</drugenddate>
        <drugtreatmentduration>125</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
        <drugdosagetext>TABLETS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NADOLOL</medicinalproduct>
        <drugdosagetext>TABLETS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugdosagetext>CAPSULES</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090820</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090411</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130529-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJCH-2010027146</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>CHILD ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
        <drugauthorizationnumb>005845</drugauthorizationnumb>
        <drugdosagetext>TEXT:UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130530-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060907</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2006AU02713</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>IMMUNOSUPPRESSANT DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALABSORPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HEART AND LUNG TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugindication>IMMUNOSUPPRESSANT DRUG THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>IMMUNOSUPPRESSANT DRUG THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugindication>IMMUNOSUPPRESSANT DRUG THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130531-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101020</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PE-SANOFI-AVENTIS-2010SA071991</companynumb>
    <primarysource>
      <reportercountry>PERU</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>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</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>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130532-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-AVENTIS-2010SA072160</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101126</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130533-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2010SE56140</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>62</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPRIVAN</medicinalproduct>
        <drugauthorizationnumb>019627</drugauthorizationnumb>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMIFENTANIL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VECURONIUM BROMIDE</medicinalproduct>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>MAINTENANCE OF ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130534-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15209117</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>BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIASTOLIC DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM T WAVE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IXEMPRA KIT</medicinalproduct>
        <drugdosagetext>INTERRUPTED ON 16JUL2010 26MG 09JUL-02SEP10</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100902</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>INTERRUPTED ON 16JUL2010. 190MG:09JUL TO 02SEP2010</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100902</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugdosagetext>1DF=1TABS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASCITES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100720</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
        <drugdosagetext>1DF=1 TO 2 TABS PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
        <drugdosagetext>1DF=1 TO 2 TABS PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
        <drugdosagetext>1DF=1 TO 2 TABS PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
        <drugdosagetext>2DF= 2 TABS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100720</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>1DF=1PATCH 150MCG</drugdosagetext>
        <drugindication>BONE PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>1DF=1PATCH 150MCG</drugdosagetext>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
        <drugdosagetext>1DF= 1 TABS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100720</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100819</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100730</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130539-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-SANOFI-AVENTIS-2010SA072311</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090826</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091028</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090826</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091229</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090826</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THERAPEUTIC RADIOPHARMACEUTICALS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101024</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130540-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2010160469</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>ALLERGY TO CHEMICALS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>022020</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101104</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAVANIC</medicinalproduct>
        <drugdosagetext>2 DOSAGE FORMS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101031</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EUPRESSYL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101030</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIPARINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
        <drugtreatmentduration>49</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BRISTOPEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101031</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOXEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101105</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINOMEL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PARENTERAL NUTRITION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101031</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130541-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TH-PFIZER INC-2010158102</companynumb>
    <primarysource>
      <reportercountry>THAILAND</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>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100220</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130542-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TH-PFIZER INC-2010158108</companynumb>
    <primarysource>
      <reportercountry>THAILAND</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>DEATH</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>20100511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100608</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130543-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-PFIZER INC-2010160223</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>3</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>PANTOZOL</medicinalproduct>
        <drugauthorizationnumb>020987</drugauthorizationnumb>
        <drugdosagetext>20 MG, DAILY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130544-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2010153713</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FAECALITH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODYNAMIC INSTABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARGATROBAN</medicinalproduct>
        <drugauthorizationnumb>020883</drugauthorizationnumb>
        <drugdosagetext>012 UG/KG/MIN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEPARIN-INDUCED THROMBOCYTOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARGATROBAN</medicinalproduct>
        <drugauthorizationnumb>020883</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101113</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101114</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTIVA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101114</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101114</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE HYDROGEN SUCCINATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101114</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLAVENTIN</medicinalproduct>
        <drugdosagetext>3 G, 2X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101111</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORADRENALINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>VASOPLEGIA SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101114</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101114</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPEGIC 1000</medicinalproduct>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101112</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETAMINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101113</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130545-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2010144356</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</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>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130546-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-10P-062-0687146-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <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>20100601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100805</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130547-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010HK16009</companynumb>
    <primarysource>
      <reportercountry>HONG KONG</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPYEMA DRAINAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101028</drugenddate>
        <drugtreatmentduration>44</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE PHOSPHATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANEXAMIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIMETHYL POLYSILOXANE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130548-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHNY2010GB00530</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL (NCH)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugauthorizationnumb>019201</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CODEINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130549-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BE80403</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTOID REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPARENT DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPHYXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CATAFLAM</medicinalproduct>
        <drugauthorizationnumb>020142</drugauthorizationnumb>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130550-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA78825</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCHIZOPHRENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>400 MG, QHS</drugdosagetext>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>300 MG, QHS (3 TABLETS)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>75 MG, QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>400 MG, QHS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COGENTIN</medicinalproduct>
        <drugdosagetext>2 MG, PRN</drugdosagetext>
        <drugindication>EXTRAPYRAMIDAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COGENTIN</medicinalproduct>
        <drugindication>SALIVARY HYPERSECRETION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUPENTIXOL</medicinalproduct>
        <drugdosagetext>3 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOLOC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>2 MG, PRN</drugdosagetext>
        <drugindication>AGITATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>1 MG, QID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>2 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE</medicinalproduct>
        <drugdosagetext>1 %, QHS 1-2 DROPS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>0.9% 1-2 DROPS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
        <drugdosagetext>8.6 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BIPHOSPHATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100926</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101030</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130551-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2010SE56297</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>AUTOIMMUNE THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARAPRES 4 MG COMPRIMIDOS</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060303</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130552-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2010SE32802</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>ONCE A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>ONCE A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130553-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-SANOFI-AVENTIS-2010SA072261</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>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TORSADE DE POINTES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTAQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>022425</drugauthorizationnumb>
        <drugdosagetext>400 MG 1-0-1 (MORGENS U. ABENDS MIT DER MAHLZEIT)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101123</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130554-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-BAXTER-2010BH027482</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONEAL DIALYSIS COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHYSIOSOL IN PLASTIC CONTAINER</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130555-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA072408</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>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</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>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTAQ</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022425</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130556-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-JNJFOC-20101108283</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPIRATION BRONCHIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOPULMONARY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA SCALE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOSOCOMIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugdosagetext>200 MG IN THE MORNING AND 100 MG IN THE NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUETIAPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130557-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MY-JNJFOC-20101108165</companynumb>
    <primarysource>
      <reportercountry>MALAYSIA</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>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAELYX</medicinalproduct>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugdosagetext>1 TIME USED</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER RECURRENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130558-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20100807735</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.24</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GALACTORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugauthorizationnumb>021999</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130559-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101108058</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98.88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
        <drugbatchnumb>1000862</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130563-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-BRACCO-000001</companynumb>
    <primarysource>
      <reportercountry>GREECE</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>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTIHANCE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021357</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NUCLEAR MAGNETIC RESONANCE IMAGING</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130564-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-AVENTIS-2010SA012850</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>CEREBELLAR ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>021759</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100112</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACILE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100113</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100113</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130565-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20101104528</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACTERIAL PYELONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HISTIOCYTOSIS HAEMATOPHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130570-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJCH-2010027145</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHILD ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
        <drugauthorizationnumb>005845</drugauthorizationnumb>
        <drugdosagetext>TEXT:UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>TEXT:UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugdosagetext>TEXT:UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugdosagetext>TEXT:UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130571-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-SANOFI-AVENTIS-2010SA071043</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED THERAPY</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEBIVOLOL HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOCORDIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101009</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISORDIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091009</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100920</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130572-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080618</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-SANOFI-AVENTIS-200813307EU</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>ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYPTORCHISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLEXANE</medicinalproduct>
        <drugbatchnumb>14318</drugbatchnumb>
        <drugauthorizationnumb>020164</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>IN VITRO FERTILISATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GESTONE</medicinalproduct>
        <drugdosagetext>DOSE AS USED: 100-150 MG</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>IN VITRO FERTILISATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080718</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGESTERONE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>IN VITRO FERTILISATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>IN VITRO FERTILISATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080519</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>IN VITRO FERTILISATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>IN VITRO FERTILISATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130577-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028803</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101121</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130578-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028878</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101115</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130580-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH024342</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130581-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-AVENTIS-2010SA071543</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>
      <patientweight>58</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL ANASTOMOTIC LEAK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100506</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100527</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATINE DAKOTA PHARM</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100506</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATINE DAKOTA PHARM</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100527</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACILE DAKOTA PHARM</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020985</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100807</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACILE DAKOTA PHARM</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020985</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100510</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100705</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100810</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130582-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-ZA-00195ZA</companynumb>
    <primarysource>
      <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>PRADAXA</medicinalproduct>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>220 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>KNEE ARTHROPLASTY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130583-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-09661BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>909771A,0D1001,NOT REPORTED,003152B</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEO-24</medicinalproduct>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130584-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028611</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>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130585-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-AVENTIS-2010SA047401</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>45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LACUNAR INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070419</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130586-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-256411USA</companynumb>
    <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>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULFATE AUTOHALER</medicinalproduct>
        <drugauthorizationnumb>021457</drugauthorizationnumb>
        <drugdosagetext>Q4 HOURS PRN</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETA BLOCKING AGENTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130587-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BAXTER-2010BH028921</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130592-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ASTRAZENECA-2010SE56098</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>710</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPIGASTRIC DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERUCTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMUCIL-2</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PALAFER</medicinalproduct>
        <drugdosagetext>1300 MG 3-5 TIMES PER WEEK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INFUFER</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100225</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUMS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugdosagetext>240 MG 1-2 TIMES DAILY</drugdosagetext>
        <drugindication>ARRHYTHMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugdosagetext>2 PUFFS BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
        <drugdosagetext>1 PUFF BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130593-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028827</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>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130594-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TH-BAXTER-2010BH028862</companynumb>
    <primarysource>
      <reportercountry>THAILAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130595-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-AVENTIS-2010SA071608</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>AMARYL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020496</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BASEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130597-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-AVENTIS-2010SA071544</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>
      <patientweight>53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL HERNIA OBSTRUCTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNAL HERNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100506</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100527</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATINE DAKOTA PHARM</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100506</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATINE DAKOTA PHARM</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100527</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100705</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100810</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACILE DAKOTA PHARM</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020985</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100510</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACILE DAKOTA PHARM</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020985</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100807</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130598-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ASTRAZENECA-2010SE55990</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>021399</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100817</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FROBEN</medicinalproduct>
        <drugindication>BACK DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130599-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ASTRAZENECA-2010SE55536</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
        <drugauthorizationnumb>050706</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100923</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130600-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101002065</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>45.36</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>020281</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130601-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>QA-JNJFOC-20101200078</companynumb>
    <primarysource>
      <reportercountry>QATAR</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>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>020281</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC ATTACK</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130602-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101108829</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>ULTRAM</medicinalproduct>
        <drugauthorizationnumb>020281</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130603-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI039597</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>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100513</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130604-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJCH-2010027147</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILD ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXTROMETHORPHAN HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>TEXT:UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORPHENIRAMINE</medicinalproduct>
        <drugdosagetext>TEXT:UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXYLAMINE</medicinalproduct>
        <drugdosagetext>TEXT:UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130605-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU352624</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CORNEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1021467</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130609-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010005320</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>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100112</drugenddate>
        <drugtreatmentduration>107</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130610-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU419537</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>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>250 A?G, UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100318</drugenddate>
        <drugtreatmentduration>302</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100318</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130611-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU347754</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>100 A?G, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE MAGNESIUM</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENZYMES</medicinalproduct>
        <drugdosagetext>UNK UNK, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>25 MG, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>UNK UNK, QWK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAX SEED OIL</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COENZYME Q10</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHROMIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOTIN</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATION</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130612-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-AVENTIS-2010SA071616</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>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELPLAT</medicinalproduct>
        <drugauthorizationnumb>021759</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM LEVOFOLINATE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130613-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20101108788</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</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>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130614-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENZYME-MOZO-1000439</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>132</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOZOBIL</medicinalproduct>
        <drugbatchnumb>10-001185</drugbatchnumb>
        <drugauthorizationnumb>022311</drugauthorizationnumb>
        <drugdosagetext>320 MCG/KG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101021</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZACITIDINE</medicinalproduct>
        <drugbatchnumb>9I088A</drugbatchnumb>
        <drugdosagetext>75 MG/M2, UNK</drugdosagetext>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101021</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugdosagetext>10 MCG/KG, UNK</drugdosagetext>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101021</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANDROGEL</medicinalproduct>
        <drugdosagetext>50 ML, PRN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>0.5 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>600 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>400 IU, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <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>NORVASC</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS HCT</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130615-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2010160421</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QRS COMPLEX PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDAREX</medicinalproduct>
        <drugauthorizationnumb>018972</drugauthorizationnumb>
        <drugdosagetext>200 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090423</drugenddate>
        <drugtreatmentduration>652</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALISKIREN</medicinalproduct>
        <drugdosagetext>300 MG, 1X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTAREG ^NOVARTIS^</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090423</drugenddate>
        <drugtreatmentduration>178</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE/FORMOTEROL FUMARATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORASEMIDE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugdosagetext>850 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOBON</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESILATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090423</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130620-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0686535-00</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>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130621-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-10P-062-0687133-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070304</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARCOXIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130622-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-10P-062-0683437-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130623-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENZYME-FLUD-1000447</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>ACUTE GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020038</drugauthorizationnumb>
        <drugdosagetext>30 MG/M2, QDX3</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IMMUNE SYSTEM DISORDER</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARA</medicinalproduct>
        <drugauthorizationnumb>020038</drugauthorizationnumb>
        <drugindication>THERAPEUTIC PROCEDURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARA</medicinalproduct>
        <drugauthorizationnumb>020038</drugauthorizationnumb>
        <drugindication>BONE MARROW TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNE GLOBULIN NOS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS, CONCENTRATED</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLATELETS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GRAFT VERSUS HOST DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNE GLOBULIN NOS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EPSTEIN-BARR VIRAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130624-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PH-BAXTER-2010BH028796</companynumb>
    <primarysource>
      <reportercountry>PHILIPPINES</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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100422</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130625-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-BAXTER-2010BH028940</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</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>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130626-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028811</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130627-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-AVENTIS-2010SA071723</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>POLYMYOSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELPLAT</medicinalproduct>
        <drugauthorizationnumb>021759</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM LEVOFOLINATE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130632-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-AVENTIS-2010SA071625</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>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEVALOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100503</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100503</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRANDOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100503</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100504</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITOROL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100502</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFAZOLIN SODIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100503</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100503</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100503</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100503</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEPETAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100503</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOBUTAMINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTSUKA MV</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugindication>HYPERGLYCAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100505</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130633-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-SANOFI-AVENTIS-2010SA071223</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIPEN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOBAY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APRESOLINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOCORDIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CILOSTAZOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130634-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-AVENTIS-2010SA071736</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>DUODENAL PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>021759</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>021759</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM LEVOFOLINATE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM LEVOFOLINATE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130635-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJCH-2010027144</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>CHILD ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
        <drugauthorizationnumb>005845</drugauthorizationnumb>
        <drugdosagetext>TEXT:UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130640-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080910</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-CELGENEUS-056-21880-10090301</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEBRIDAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SMECTA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIORFAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130645-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-10P-028-0686056-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHIAL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TERMINAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAVIK</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020528</drugauthorizationnumb>
        <drugdosagetext>4 MG ONCE DAILY</drugdosagetext>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100609</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HCT</medicinalproduct>
        <drugdosagetext>DOSE/DAY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130646-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2008BH010997</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>100</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>117067</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>117067</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080313</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>PROPOXYPHENE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</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>FUROSEMIDE</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>SIMVASTATIN</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>CAPTOPRIL</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>PREGABALIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130647-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AMGEN-FRANI2010000665</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARBEPOETIN ALFA</medicinalproduct>
        <drugdosagetext>30 MG, Q2WK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090404</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UN ALFA</medicinalproduct>
        <drugdosagetext>1 A?G, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENITEC                            /00574901/</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORDITROPINE SIMPLEXX</medicinalproduct>
        <drugdosagetext>3.3 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICOFENOLATO MOFETIL G</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KAYEXALATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEDROGYL</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugdosagetext>2 DF, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
        <drugdosagetext>250 MG, TID</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130648-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-DE-05518GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN AND DIPYRIDAMOLE</medicinalproduct>
        <drugauthorizationnumb>020884</drugauthorizationnumb>
        <drugdosagetext>DIPYRIDAMOLE 8 G PLUS ACETYLSALICYLIC ACID 1 G</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYAMEMAZINE</medicinalproduct>
        <drugdosagetext>75 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROMIDE</medicinalproduct>
        <drugdosagetext>900 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVASTIGMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMISULPRIDE</medicinalproduct>
        <drugdosagetext>400 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130653-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033817</companynumb>
    <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>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091021</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130654-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2010029209</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>29</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugauthorizationnumb>050693</drugauthorizationnumb>
        <drugdosagetext>600 MG, SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100212</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugdosagetext>1 DF, SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100212</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HELICIDINE</medicinalproduct>
        <drugdosagetext>15 ML, SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100212</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130655-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2010160540</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>CARDIOVASCULAR INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA STAPHYLOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130656-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2006144302</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCREATININAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUNITINIB MALATE</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>25 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUINDIONE</medicinalproduct>
        <drugindication>THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061120</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130657-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007039224</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070422</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APROVEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMETANIDE</medicinalproduct>
        <drugdosagetext>THREE IN THE MORNING AND TWO AT NIGHT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOSULEPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTRAPID</medicinalproduct>
        <drugdosagetext>AS DIRECTED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOCONAZOLE</medicinalproduct>
        <drugdosagetext>2% AS DIRECTED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE</medicinalproduct>
        <drugdosagetext>50 MCG DAILY AND 100 MCG TWO DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
        <drugdosagetext>TWO DOSES</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugdosagetext>TWO DOSE FORMS TWICE DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMETEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130658-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010136710</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
        <drugauthorizationnumb>021845</drugauthorizationnumb>
        <drugdosagetext>20 MG, 3X/DAY</drugdosagetext>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugdosagetext>125 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCLERODERMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130659-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2010047436</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD MAGNESIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECG SIGNS OF MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugauthorizationnumb>050670</drugauthorizationnumb>
        <drugdosagetext>500 MG, 3 TIMES WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100225</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>AMIODARONE</medicinalproduct>
        <drugdosagetext>200 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPRAVENTRICULAR TACHYCARDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100225</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE</medicinalproduct>
        <drugdosagetext>2.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOCISTEINE</medicinalproduct>
        <drugdosagetext>750 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
        <drugdosagetext>20 MG, 2X/DAY</drugdosagetext>
        <drugindication>ANGINA PECTORIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130660-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-PFIZER INC-PL-WYE-H17426510</companynumb>
    <primarysource>
      <reportercountry>POLAND</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>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOGEN RESISTANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYGACIL</medicinalproduct>
        <drugauthorizationnumb>021821</drugauthorizationnumb>
        <drugindication>INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYGACIL</medicinalproduct>
        <drugauthorizationnumb>021821</drugauthorizationnumb>
        <drugindication>CANDIDIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAZOCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISEPTOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130661-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-PFIZER INC-2010147998</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOMATROPIN</medicinalproduct>
        <drugauthorizationnumb>020280</drugauthorizationnumb>
        <drugdosagetext>0.6 MG, UNK</drugdosagetext>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101018</drugenddate>
        <drugtreatmentduration>1618</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugdosagetext>30 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130662-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2010150156</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>ARTERIOSCLEROSIS CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JEJUNAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>60 MG/M2, THREE TIMES WEEKLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100319</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>050778</drugauthorizationnumb>
        <drugdosagetext>50 MG/M2, THREE TIMES WEEKLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100319</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>625 MG/M2, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100324</drugenddate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130663-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2009194705</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AVOIDANT PERSONALITY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MAJOR DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERMAL BURN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TIBIA FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080311</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>ILLEGIBLE DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugdosagetext>10 MG, 4X/DAY AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
        <drugdosagetext>AS NEEDED EVERY FOUR HOURS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130665-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-FR-WYE-G06734710</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>CLOSTRIDIUM DIFFICILE COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAZOCILLINE</medicinalproduct>
        <drugauthorizationnumb>050684</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080322</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080404</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARGOCID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080402</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIENAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080328</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130666-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10112528</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>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130667-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA070795</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>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020164</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101104</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130668-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-CELGENEUS-013-21880-10110278</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130669-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2009BH018876</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>087095</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>HAEMODIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>087095</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>087095</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>087092</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>097079</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>087092</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>087095;087092;097079</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>097079</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>087095;087092;097079</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>087092</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>087095;087092;097079</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>097079</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HECTOROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENOFER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHOSLO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HECTOROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130670-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-CELGENEUS-056-C5013-10101444</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CC-5013</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090922</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CC-5013</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101013</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090922</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100923</drugstartdate>
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        <drugenddate>20101013</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KARDEGIC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APROVEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECTOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMAREL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMAREL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>NEPHROPATHY</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFFU K</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERSYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090321</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090905</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091012</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPEGIC 1000</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090922</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100325</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100720</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100720</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARDYFERON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPALGIC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130671-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-CELGENEUS-062-21880-08051461</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>92</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080420</drugenddate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080509</drugenddate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080503</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080430</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080428</drugenddate>
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    </patient>
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  <safetyreport>
    <safetyreportid>7130672-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA070909</companynumb>
    <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>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020164</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
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  <safetyreport>
    <safetyreportid>7130676-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
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    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJCH-2010027140</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>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILD ABUSE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>WRONG DRUG ADMINISTERED</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXTROMETHORPHAN HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>TEXT:UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXEPIN HCL</medicinalproduct>
        <drugdosagetext>TEXT:UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORPHENIRAMINE MALEATE</medicinalproduct>
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        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
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        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBINOXAMINE MALEATE</medicinalproduct>
        <drugdosagetext>TEXT:UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
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  <safetyreport>
    <safetyreportid>7130677-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-CELGENEUS-144-50794-10102821</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME TRANSFORMATION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDAZA</medicinalproduct>
        <drugauthorizationnumb>050794</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130678-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ELI_LILLY_AND_COMPANY-CA201010004955</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>29.478</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADCIRCA</medicinalproduct>
        <drugauthorizationnumb>021368</drugauthorizationnumb>
        <drugdosagetext>20 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101009</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BOSENTAN</medicinalproduct>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANEXAMIC ACID</medicinalproduct>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130679-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-ELI_LILLY_AND_COMPANY-CH201011006463</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130680-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201009007125</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84.807</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>CORONARY ARTERIAL STENT INSERTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>12.5 MG, 2/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugindication>ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugdosagetext>1 D/F, 2/D</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugdosagetext>0.4 MG, AS NEEDED</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130681-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011005282</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>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130682-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011006221</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>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130683-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-ELI_LILLY_AND_COMPANY-CH201011006629</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130684-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201006003264</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 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK HYPOGLYCAEMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOULDER OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>A687388C</drugbatchnumb>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>12 U, 3/D</drugdosagetext>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>A687388C</drugbatchnumb>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>A690538C</drugbatchnumb>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>12 U, 3/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>A690538C</drugbatchnumb>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>A688779C</drugbatchnumb>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>12 U, 3/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>A688779C</drugbatchnumb>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130685-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GENENTECH-304135</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130686-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-CELGENEUS-167-21880-10102964</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100324</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100324</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LMWH</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130687-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRACCO-005501</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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPTIMARK</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DEAFNESS UNILATERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100727</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPTIMARK</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPTIMARK</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>AMNESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100727</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTIHANCE</medicinalproduct>
        <drugbatchnumb>S0P054A</drugbatchnumb>
        <drugauthorizationnumb>021357</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NUCLEAR MAGNETIC RESONANCE IMAGING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTIHANCE</medicinalproduct>
        <drugbatchnumb>S0P054A</drugbatchnumb>
        <drugauthorizationnumb>021357</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MASTOIDITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugindication>OTITIS MEDIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugindication>EUSTACHIAN TUBE DYSFUNCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugdosagetext>ONE PER DAY FOR 7 DAYS</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130688-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GENENTECH-310161</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR DEGENERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITALUX PLUS</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>LUTEIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130689-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-09110274</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR FLARE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130690-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-GENENTECH-310087</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>700 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>138 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>7400 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>160 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MTX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>5500 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROXIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DI-ADRESON-F</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100927</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130691-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033911</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</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>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101118</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130692-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RU-GENENTECH-309645</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>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-HODGKIN'S LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130693-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-GENENTECH-307248</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100501</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130697-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-SANOFI-AVENTIS-2010SA071554</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>115</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>20 IU IN AM AND 20 IU AT NIGHT</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugdosagetext>3 INJECTIONS OF 15 IU DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMETEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130698-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-AVENTIS-2010SA070170</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>79.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLETAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANCARON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>DOSE: TWO AND A HALF 2.5-MG TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIGLITOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYRADIN</medicinalproduct>
        <drugdosagetext>DOSE: ONE AND A HALF 50-MCG TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE/LOSARTAN POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTIST</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIGMART</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130699-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100216</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033830</companynumb>
    <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>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100120</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130700-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033835</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>THROMBOSIS IN DEVICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091214</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130701-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20081001</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-CELGENEUS-056-21880-08100238</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>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080106</drugenddate>
        <drugtreatmentduration>48</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORACILLIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALACYCLOVIR HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINTROM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130707-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-593388</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BASEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080717</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130708-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-385941</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCORIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROSTEP</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130709-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-432356</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACROCHORDON</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELANOCYTIC NAEVUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN PAPILLOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENERIC DRUGS</medicinalproduct>
        <drugdosagetext>UNSPECIFIED OVER-THE-COUNTER MEDICATION TAKEN FOR COLDS AND/OR FLU.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTIC NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130710-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-523596</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUPUS-LIKE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TICLOPIDINE HCL</medicinalproduct>
        <drugauthorizationnumb>019979</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CAROTID ARTERY STENT INSERTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070516</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CAROTID ARTERY STENT INSERTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN HYPERTENSION DRUG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED OTHER MEDICATION</medicinalproduct>
        <drugdosagetext>TOTAL OF 9 DRUGS INCLUDING ANTIHYPERTENSIVE DRUGS NOS WERE ALL WITHDRAWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130711-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-632807</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</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>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
        <drugdosagetext>EVERY MORNING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BREVOXYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130712-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-680409</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>111.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19961001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130713-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-713347</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASTUZUMAB</medicinalproduct>
        <drugbatchnumb>B1519</drugbatchnumb>
        <drugdosagetext>DOSAGE FORM:INFUSION,FREQUENCY:21/21,LAST DOSE PRIOR TO SAE:02 SEP 2010.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100922</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASTUZUMAB</medicinalproduct>
        <drugbatchnumb>B1519</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERTUZUMAB</medicinalproduct>
        <drugbatchnumb>771287</drugbatchnumb>
        <drugdosagetext>DOSAGE FORM:INFUSION, FREQUENCY:21/21, DATE OF LAST DOSE PRIOR TO SAE: 02 SEP 2010</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100922</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERTUZUMAB</medicinalproduct>
        <drugbatchnumb>771287</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugbatchnumb>9F44173</drugbatchnumb>
        <drugdosagetext>DOSAGE FORM:INFUSION, FREQUENCY:21/21, DATE OF LAST DOSE PRIOR TO SAE:02 SEP 2010.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100922</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugbatchnumb>9F44173</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugbatchnumb>D94966</drugbatchnumb>
        <drugdosagetext>DOSAGE FORM:INFUSION,FREQUENCY:21/21, LAST DOSE PRIOR TO SAE: 02 SEP 2010</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100922</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugbatchnumb>D94966</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FILGRASTIM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FILGRASTIM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101018</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130714-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-CELGENEUS-083-21880-10113031</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>7130715-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-717693</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>210586, 210589, 210587</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON ALFA</medicinalproduct>
        <drugbatchnumb>904732, 904782</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
        <drugdosagetext>FREQUENCY: DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100608</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130716-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-718631</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>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOLIOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000704</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000824</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO TRI-CYCLEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130717-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-JNJCH-2010027068</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</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>ACTIGRIP</medicinalproduct>
        <drugdosagetext>TEXT:FOUR TABLETS TOTAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFLUENZA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>TEXT:500MG TWO TABLETS DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFLUENZA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101120</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130718-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-722536</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>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL FISSURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130723-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-722605</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC FATIGUE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19830101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19851201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130725-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033410</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugbatchnumb>CDB</drugbatchnumb>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADCIRCA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NATEGLINIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130726-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-722607</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>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL FISSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC FATIGUE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>XEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYTONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020819</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETAPHIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020819</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOCOID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020819</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130727-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-722610</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19951101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONTRACEPTIVE</medicinalproduct>
        <drugdosagetext>REPORTED AS BIRTH CONTROL (MEDICATION)</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130728-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-722628</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL HERPES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130729-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-724891</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VISUAL FIELD DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>DRUG NAME: XELODA 300(CAPECITABINE), 2 WEEKS ADMINISTRATION FOLLOWED BY 1 WEEK REST.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELPLAT</medicinalproduct>
        <drugdosagetext>DOSAGE IS UNCERTAIN.ACTION TAKEN: DISCONTINUED.</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130730-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-443598</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MAJOR DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIRECTAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIOLENCE-RELATED SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990825</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130731-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-557524</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMIFLU</medicinalproduct>
        <drugauthorizationnumb>021087</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080401</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugdosagetext>20 MG AT BED TIME AND 7.5 MG IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130732-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-696699</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>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>DISCONTINUED</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100310</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GASTER D</medicinalproduct>
        <drugdosagetext>DOSAGE IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANPLAG</medicinalproduct>
        <drugdosagetext>DRUG:ANPLAG(SARPOGRELATE HYDROCHLORIDE), FORM:PERORAL AGENT, DOSAGE IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>DOSAGE IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>AMLODIN OD(AMLODIPINE BESILATE), DOSAGE IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEIBULE</medicinalproduct>
        <drugdosagetext>DOSAGE IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130737-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-722290</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAL FISSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010901</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEFLEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130739-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033755</companynumb>
    <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>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071015</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130740-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13346BP</companynumb>
    <primarysource>
      <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>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130741-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC.-2010-RO-01553RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugauthorizationnumb>076844</drugauthorizationnumb>
        <drugdosagetext>120 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugauthorizationnumb>076844</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130742-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13345BP</companynumb>
    <primarysource>
      <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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101129</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130743-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-722685</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>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL DRYNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL DRYNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19910501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>40 MG BID FOR 5 MONTHS IN 1/04. THEN 20 MG BID IN FEB APR AND JUN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEFLEX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KENALOG</medicinalproduct>
        <drugdosagetext>IL.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030808</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130744-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-12677BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC 75</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020520</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUCRALFATE</medicinalproduct>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>JOINT SWELLING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130745-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ASTRAZENECA-2010SE52406</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21121</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021689</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC ULCER HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101031</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERLIXIT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130746-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2010SE55578</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>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <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>HALLUCINATION, AUDITORY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL NEBULIZERS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130747-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-722765</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19900410</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>40 MG IN MORNING, 60 MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19900601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130748-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-733323</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>BENIGN BONE NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL CORD NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugdosagetext>DOSE FORM REPORTED AS INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100716</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugdosagetext>DOSE FORM : SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100922</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELCOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100716</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100623</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOGLIBOSE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100323</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100625</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101005</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130749-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-737544</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTATIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130750-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10112429</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>70.824</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100909</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101011</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130751-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040721</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-741425</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130752-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071010</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-741633</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130753-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-718694</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130754-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ASTRAZENECA-2010SE55352</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>BLOOD CHROMOGRANIN A INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PARATHYROID HORMONE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugdosagetext>20 MG/DAY IN THE MORNING PLUS 20 MG/DAY IN THE EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugtreatmentduration>40</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugdosagetext>20 MG/DAY IN THE EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>40</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugdosagetext>20 MG/DAY IN THE EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130755-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2010SE53966</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>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101017</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101017</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050124</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130756-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-722558</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>51.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN CHAPPED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19830622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19831019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19871017</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19930707</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130757-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-CELGENEUS-144-50794-10112754</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDAZA</medicinalproduct>
        <drugauthorizationnumb>050794</drugauthorizationnumb>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIINFLAMMATORY AGENTS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANALGESICS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130758-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0687487-00</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>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</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>20100501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130759-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-730872</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100415</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100427</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100708</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100722</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100819</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100609</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100218</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100303</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100317</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100415</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100427</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100527</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100804</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100918</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBRUPROFEN</medicinalproduct>
        <drugdosagetext>FORM: PERORAL AGENT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBRUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEFANIL</medicinalproduct>
        <drugdosagetext>FORM: PERORAL AGENT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091014</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISCOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFACLOR</medicinalproduct>
        <drugdosagetext>FORM: PERORAL AGENT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOMYCIN</medicinalproduct>
        <drugdosagetext>FOPRM: FORM: PERORAL AGENT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100303</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFFERIN</medicinalproduct>
        <drugdosagetext>NOTE: PROPER QUANTITY</drugdosagetext>
        <drugadministrationroute>003</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DALACIN</medicinalproduct>
        <drugdosagetext>NOTE: PROPER QUANTITY</drugdosagetext>
        <drugadministrationroute>003</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEVALOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100722</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIDOXAL CALCIUM PHOSPHATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100708</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091110</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130762-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-731747</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FACIAL SPASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100812</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAKTAR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130763-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-733705</companynumb>
    <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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100902</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugdosagetext>DRUG NAME REPORTED AS: ACTINAL.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>SLIDING DOSE.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>DRUG NAME REPORTED AS: METROPOLOL.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>DRUG NAME REPORTED AS: SYNVASTIN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
        <drugdosagetext>DRUG NAME REPORTED AS: MECLAZINE.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130764-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2009KR49178</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CGP 57148B T35717+</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070704</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PEPTIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080714</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIXONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080723</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLAFORAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080823</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130765-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-ROCHE-733897</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130766-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-736135</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNODEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICES OESOPHAGEAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICOSE VEIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2A</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2A</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2A</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUPRADYN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130768-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010MX34459</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPENDICECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETERISATION VENOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYSTERECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OOPHORECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE LEIOMYOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>2 DF, DAILY (160 MG)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>1 DF, (80 MG DAILY)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>0.5 DF, DAILY</drugdosagetext>
        <drugindication>TACHYCARDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPEUTICS NOS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100503</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130769-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010IL77669</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</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>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVEROLIMUS</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130770-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US78820</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>875 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130771-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP33067</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>10 UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100429</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100716</drugenddate>
        <drugtreatmentduration>64</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100916</drugenddate>
        <drugtreatmentduration>57</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101028</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUNITINIB MALATE</medicinalproduct>
        <drugdosagetext>50 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100107</drugenddate>
        <drugtreatmentduration>85</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugdosagetext>8 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugdosagetext>1 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100507</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYRADIN</medicinalproduct>
        <drugdosagetext>50</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLORIC</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER D</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100521</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130772-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-738131</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 FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACTEMRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>AMYLOIDOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130773-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-US-EMD SERONO, INC.-7029233</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>REBIF</medicinalproduct>
        <drugbatchnumb>Y14A1013</drugbatchnumb>
        <drugindication>SECONDARY PROGRESSIVE MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYPROFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINE C</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITTA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130774-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-US-EMD SERONO, INC.-7014395</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>42.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOMIPRAMINA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMAZEPAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130775-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-US-EMD SERONO, INC.-7028108</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130776-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101121</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-US-EMD SERONO, INC.-7029103</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTIPHOSPHOLIPID SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101121</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLORIS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101114</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130777-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-US-EMD SERONO, INC.-7029083</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060710</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130778-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-US-EMD SERONO, INC.-7029082</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>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugbatchnumb>Y16A5382</drugbatchnumb>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100602</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130779-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7028029</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
        <drugtreatmentduration>195</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130780-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ROCHE-740221</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>TEMPORARILY INTERRUPTED, FREQUENCY: 12 HR X 14 DAYS, DATE OF LAST DOSE PRIOR TO SAE: 28 OCT 2010</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>DOSAGE FORM: VIAL. TEMPORARILY INTERRUPTED, DATE OF LAST DOSE PRIOR TO SAE: 14 OCT 2010</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN</medicinalproduct>
        <drugdosagetext>DOSAGE NOT REPORTED</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN</medicinalproduct>
        <drugdosagetext>TEMPORARILY INTERRUPTED, DATE OF LAST DOSE PRIOR TO SAE: 14 OCT 2010</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130781-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010KR76605</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</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>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400MG (04 TABLETS /DAY)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTASES TO LIVER</drugindication>
        <drugtreatmentduration>1460</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130782-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP78877</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>160 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIVADIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080109</drugenddate>
        <drugtreatmentduration>2304</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071204</drugenddate>
        <drugtreatmentduration>1064</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugdosagetext>8 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugdosagetext>12 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERSYL</medicinalproduct>
        <drugdosagetext>8 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTIST</medicinalproduct>
        <drugdosagetext>15 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070425</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT CC</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CERCINE</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLORIC</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060906</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TICLOPIDINE HCL</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060906</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACINON</medicinalproduct>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO</medicinalproduct>
        <drugdosagetext>600 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061004</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130783-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP41370</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ICL670A ICL+DISTAB</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1000 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON OVERLOAD</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090530</drugenddate>
        <drugtreatmentduration>213</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ICL670A ICL+DISTAB</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1000 MG, DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051205</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED CELLS MAP</medicinalproduct>
        <drugdosagetext>2 UNITS EVERY 4 WEEKS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091016</drugenddate>
        <drugtreatmentduration>338</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130784-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010US12734</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPYEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>5 MEQ/KG, QD</drugdosagetext>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100817</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LBH589 LBH+CAP</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100817</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>10 MG/KG, Q14D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100817</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND HYDROCODONE BITARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
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    </patient>
  </safetyreport>
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    <safetyreportid>7130785-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-741689</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugdosagetext>FORM:INFUSION</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130786-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-741712</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130787-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP15178</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugtreatmentduration>945</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INCADRONIC ACID</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>579</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130788-0</safetyreportid>
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    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010NL78475</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4MG/5ML</drugdosagetext>
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        <drugstartdate>20100830</drugstartdate>
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  <safetyreport>
    <safetyreportid>7130789-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP69293</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOCAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130790-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-742067</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>FRACTURE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
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        <drugenddate>20080812</drugenddate>
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      <drug>
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        <drugstartdate>20081008</drugstartdate>
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      <drug>
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        <drugstartdate>20081203</drugstartdate>
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        <drugenddate>20081203</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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      <drug>
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      <drug>
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      <drug>
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      <drug>
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      <drug>
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      <drug>
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      <drug>
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      <drug>
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      <drug>
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      <drug>
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      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugdosagetext>FORM: PERORAL AGENT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080811</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130791-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010FR17605</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER CATHETERISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM PROSTATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC ENLARGEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMN107 AMN+CAP</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>600 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101024</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIVEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOPTOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130792-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010TW48251</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>ANAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>600 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080310</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130793-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP17075</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>HYPERBARIC OXYGEN THERAPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INCADRONIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130794-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2009JP31798</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LAGOPHTHALMOS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAIL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPERATURE INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130795-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJCH-2010027210</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>48.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEILITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISTERINE WHITENING DISOLVING STRIPS</medicinalproduct>
        <drugbatchnumb>3161439</drugbatchnumb>
        <drugdosagetext>TEXT:TWO STRIPS ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DENTAL CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>TEXT:ONE DAILY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130796-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-742117</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugdosagetext>FORM: INFUSION</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130797-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010TR08371</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>51</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOPHLEBITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CERTICAN</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>1.5 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091023</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DELTACORTRIL</medicinalproduct>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYFORTIC</medicinalproduct>
        <drugdosagetext>360 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESFERAL</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130798-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010GB14207</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ORAL SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONATE T29581+SOLINJ+BM</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100831</drugenddate>
        <drugtreatmentduration>470</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORMONES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130799-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010FR17734</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIARY DRAINAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLANGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIGH FREQUENCY ABLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBILIRUBINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CERTICAN</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>1.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEART TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100728</drugenddate>
        <drugtreatmentduration>308</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>50 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEART TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEART TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090918</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130800-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010CA05996</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIAL STENT INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMN107 AMN+CAP</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100418</drugenddate>
        <drugtreatmentduration>153</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMICRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMUCIL-2</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEMCORT HC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVEENO ANTI-ITCH</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130801-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010TR16778</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOGENITAL WARTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAPILLOMA VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FTY 720 FTY+CAP+MSC</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>DOSE BLINDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100526</drugenddate>
        <drugtreatmentduration>639</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FTY 720 FTY+CAP+MSC</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100527</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130802-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010FR60885</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYFORTIC</medicinalproduct>
        <drugauthorizationnumb>050791</drugauthorizationnumb>
        <drugdosagetext>1.44 G, QD</drugdosagetext>
        <drugindication>NEPHROTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
        <drugdosagetext>35 MG</drugdosagetext>
        <drugindication>NEPHROTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROID NOS</medicinalproduct>
        <drugdosagetext>30 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130803-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-722727</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED GASTRIC EMPTYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFLUX OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSFERRIN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19910701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130804-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2009US03380</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>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMBOLISM ARTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO CENTRAL NERVOUS SYSTEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LYMPH NODES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENICILLIN ^GRUNENTHAL^</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130805-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010DE16909</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>10 MG / DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101107</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130806-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR80997</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </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>ACLASTA</medicinalproduct>
        <drugbatchnumb>UNK.</drugbatchnumb>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG/100 ML</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130807-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US80893</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN CARDIAC DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG OD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TASIGNA</medicinalproduct>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101113</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130808-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US76357</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>500 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071024</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130809-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010PL17938</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PITYRIASIS ROSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STI571/CGP57148B T35717+TAB</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100604</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130810-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010CA17909</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER CATHETERISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG CONSOLIDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THORACIC CAVITY DRAINAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOBACCO WITHDRAWAL SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>2.5 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLADDER CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101018</drugenddate>
        <drugtreatmentduration>57</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE COMPARATOR COMP-GEM+</medicinalproduct>
        <drugdosagetext>100 MG/M2 WEEKLY</drugdosagetext>
        <drugindication>BLADDER CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130811-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US79912</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130812-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP80518</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>DIVERTICULUM INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ICL670A ICL+DISTAB</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>500 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON OVERLOAD</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100419</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130813-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-734768</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOOSE TOOTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIODONTAL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BALSALAZIDE DISODIUM</medicinalproduct>
        <drugdosagetext>DOSE:9 DAILY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130814-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-735108</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>LAST DOSE PRIOR TO SAE: 20 AUGUST 2010</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>LAST DOSE PRIOR TO SAE: 20 AUGUST 2010, DOSE: 6 AUC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugdosagetext>LAST DOSE PRIOR TO SAE: 20 AUGUST 2010</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100802</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100802</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100823</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100611</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130815-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10112485</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>GALLBLADDER CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100726</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130816-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-ROCHE-735770</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAL SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugbatchnumb>9043B01, 6258B01</drugbatchnumb>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>LAST DOSE PRIOR TO SAE: 20 OCTOBER 2010, PERMANENTLY DISCONTINUED.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>H0109B01</drugbatchnumb>
        <drugdosagetext>LAST DOSE PRIOR TO SAE: 06 OCTOBER 2010. PERMANENTLY DISCONTINUED.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB</medicinalproduct>
        <drugbatchnumb>B2008B03</drugbatchnumb>
        <drugdosagetext>FREQUENCY: QD. LAST DOSE PRIOR TO SAE: 19 OCTOBER 2010, PERMANEMTLY DISCONTINUED.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130817-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-739516</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLIOBLASTOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL HERPES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>FORM: INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APO-SULFATRIM</medicinalproduct>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130818-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-05P-167-0313976-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>2.45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CLEFT PALATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL ANTICONVULSANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT DEFORMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130819-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-740400</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WOUND COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION STAPHYLOCOCCAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>1000 MG/M2, BID, D1-D15 OF 3 WEEK CYCLE, LAST DOSE PRIOR TO SAE ON 14 MAR 2010.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100722</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>50 MG/M2 ON D1, 8, 15, 22 AND 29</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100312</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130820-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-10P-056-0684179-00</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAXY</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLUPRED</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KARDEGIC</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COLCHIMAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100330</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130821-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070305</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-741443</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130822-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10112753</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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130823-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7026005</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL/CHLOR 50-25</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130824-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040623</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-742465</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>HERCEPTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130825-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HU-ROCHE-742795</companynumb>
    <primarysource>
      <reportercountry>HUNGARY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMBOLISM VENOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>DOSE: 2 X 400 MG.  LAST DATE PRIOR TO SAE: 22 JULY 2010.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100722</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130828-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071010</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-742998</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130829-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-743571</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RENAL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGICAL PROCEDURE REPEATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSPLANT FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130830-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-743888</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugauthorizationnumb>013263</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130831-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101121</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IR-ROCHE-743982</companynumb>
    <primarysource>
      <reportercountry>IRAN (ISLAMIC REPUBLIC OF)</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>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>FORM:INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>REPORTED:LOCOVERIN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130832-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-744047</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130833-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-744597</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>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugauthorizationnumb>017581</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130834-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091228</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-744668</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE SODIUM</medicinalproduct>
        <drugauthorizationnumb>050585</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSELTAMIVIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>H1N1 INFLUENZA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAMIVIR</medicinalproduct>
        <drugindication>H1N1 INFLUENZA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMANTADINE HCL</medicinalproduct>
        <drugindication>H1N1 INFLUENZA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIMANTADINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>H1N1 INFLUENZA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130836-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070920</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-742193</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130837-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071221</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-742210</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130840-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201005001262</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID ADENOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A685003C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090310</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A728051C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090310</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RYTHMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130841-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-742809</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT TACHYPNOEA OF THE NEWBORN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OSELTAMIVIR</medicinalproduct>
        <drugauthorizationnumb>021087</drugauthorizationnumb>
        <drugdosagetext>DOSE FORM: ORAL FORMATION(NOT OTHERWISE SPECIFIED)</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091102</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130842-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HR-ROCHE-743011</companynumb>
    <primarysource>
      <reportercountry>CROATIA (local name: Hrvatska)</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>103</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>GIVEN AS DIVIDED DOSE, D1-14 OF 21 D CYCLE.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130843-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EC-ROCHE-743822</companynumb>
    <primarysource>
      <reportercountry>ECUADOR</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>DOSE REPORTED AS 21 MG/ML</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugdosagetext>FREQUENCY REPORTED AS ONCE EVERY INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANTIEMETIC SUPPORTIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100502</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130846-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101121</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IR-ROCHE-743861</companynumb>
    <primarysource>
      <reportercountry>IRAN (ISLAMIC REPUBLIC OF)</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>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>FORM: INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>DRUG NAME REPORTED AS : ^LOCOVERIN^</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130847-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010FR12862</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CITROBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>050735</drugauthorizationnumb>
        <drugdosagetext>200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext>2 G</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
        <drugdosagetext>7 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100612</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugdosagetext>80 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROVALCYTE</medicinalproduct>
        <drugdosagetext>450 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100707</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROVALCYTE</medicinalproduct>
        <drugdosagetext>NO TREATMENT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100809</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROVALCYTE</medicinalproduct>
        <drugdosagetext>450 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100823</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100708</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMEVAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100809</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130848-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-743884</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130849-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101121</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IR-ROCHE-743909</companynumb>
    <primarysource>
      <reportercountry>IRAN (ISLAMIC REPUBLIC OF)</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130850-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-ROCHE-744064</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>
      <patientweight>74</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALVEOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>DAY 1 THROUGH 14</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN DETEMIR</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130851-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-744066</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>ISOTRETINOIN</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>DISPENSED ISOTRETINOIN 40 MG CAPSULE ON 30 OCT 2009</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091030</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARAVIS</medicinalproduct>
        <drugdosagetext>DISPENSED ISOTRETINOIN 40 MG CAPSULE ON 23 DEC 2009, 40MG ON 27 FEB 2010 AND 30 MG ON 27 AUG 2010</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091223</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130852-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-744267</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACUTAN</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130853-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-744507</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130856-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-744712</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL CALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS NONINFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugdosagetext>600 MG IN MORNING AND 400 MG IN EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PF-00868554 (HCV POLYMERASE INHIBITOR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100820</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100820</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130857-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SHIRE-SPV1-2010-02077</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>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSRENOL</medicinalproduct>
        <drugauthorizationnumb>021468</drugauthorizationnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100615</drugenddate>
        <drugtreatmentduration>244</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugdosagetext>1 G, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugdosagetext>2 UNK, UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100809</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugdosagetext>3 UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100810</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL</medicinalproduct>
        <drugdosagetext>0.25 UG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugdosagetext>300 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIGMART</medicinalproduct>
        <drugdosagetext>15 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITOROL</medicinalproduct>
        <drugdosagetext>40 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID                          /00142207/</medicinalproduct>
        <drugdosagetext>36 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER D</medicinalproduct>
        <drugdosagetext>10 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugdosagetext>1 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOSENN                            /00476901/</medicinalproduct>
        <drugdosagetext>0.25 UG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOZYM</medicinalproduct>
        <drugdosagetext>100 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOLAN                            /00014302/</medicinalproduct>
        <drugdosagetext>40 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTIST</medicinalproduct>
        <drugdosagetext>2.5 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHINESE HARB (KANZO-TO)</medicinalproduct>
        <drugdosagetext>2.5 G, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugdosagetext>2.5 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NESP</medicinalproduct>
        <drugdosagetext>30 UG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130858-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033869</companynumb>
    <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 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101013</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130859-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010002485</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>PROCRIT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130860-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-744740</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>158</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACTEMRA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LERCANIDIPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN/HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HCT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXAT</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXAT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXAT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130861-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13364BP</companynumb>
    <primarysource>
      <qualification>3</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>20101129</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130862-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13344BP</companynumb>
    <primarysource>
      <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>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101129</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130864-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13301BP</companynumb>
    <primarysource>
      <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>AGGRENOX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020884</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugindication>TYPE 2 DIABETES MELLITUS</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>7130865-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US70362</companynumb>
    <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>MASTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130866-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-ASTRAZENECA-2010SE55486</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATONIC URINARY BLADDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130867-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ASTRAZENECA-2010SE55499</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>1.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CATHETER SITE RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA NEONATAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEROPENEM TRIHYDRATE</medicinalproduct>
        <drugauthorizationnumb>050706</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEONATAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101024</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFACALCIDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENICILLIN G</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAFFEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFOTAXIME SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CUROSURF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DALIVIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAVISCON INFANT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INTRALIPID 10%</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KAY CIEL DURA-TABS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM DIHYDROGEN PHOSPHATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUXAMETHONIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYTRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOCOPHEROL CONCENTRATE CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOTAL PRENTERAL NUTRITION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITLIPID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130868-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2010SE55677</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>GOITRE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXACOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130869-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-744762</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugdosagetext>FORM: INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRELONE</medicinalproduct>
        <drugdosagetext>STARTED A LONG TIME AGO</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>STARTED A LONG TIME AGO</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>STARTED A LONG TIME AGO</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>STARTED A LONG TIME AGO</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130870-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010PH80421</companynumb>
    <primarysource>
      <reportercountry>PHILIPPINES</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>RENAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TASIGNA</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>800 MG, UNK</drugdosagetext>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130871-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010IT73911</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMAL NEWBORN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DESFERRIOXAMINE MESYLATE</medicinalproduct>
        <drugauthorizationnumb>016267</drugauthorizationnumb>
        <drugindication>THALASSAEMIA BETA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPATITIS B VACCINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130872-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-744981</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>PEMPHIGOID</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130875-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006775</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>PROCRIT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130876-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-744835</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>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugbatchnumb>BH08</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130877-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-744858</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>ACTION TAKEN: DISCONTINUED.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELPLAT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130878-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ASTRAZENECA-2010SE55503</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>TWO INHALATIONS TWICE A DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DYSPNOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130879-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-744931</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PUSTULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACTEMRA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUENSYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130880-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033906</companynumb>
    <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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130881-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-744934</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VIITH NERVE PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130883-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-730055</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugbatchnumb>RJ1101</drugbatchnumb>
        <drugauthorizationnumb>017533</drugauthorizationnumb>
        <drugdosagetext>0.5 TAB/DAY AT NIGHT; START DATE: LONG TIME AGO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
        <drugdosagetext>1 CAP/ AT NIGHT; START DATE: LONG TIME AGO</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSCAL D</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTROLIVE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130884-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-D01200905870</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugindication>PULMONARY EMBOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090918</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>020164</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PULMONARY EMBOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090922</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugdosagetext>200 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>500 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>4 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090919</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130885-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US81179</companynumb>
    <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>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130887-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US81077</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130888-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US81165</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SICKLE CELL ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130889-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2008US37010</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>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON METABOLISM DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130891-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GENENTECH-310160</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHARLES BONNET SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBARACHNOID HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KENACORT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130892-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PERRIGO-10US015072</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>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TUSSIN DM LIQ 359</medicinalproduct>
        <drugbatchnumb>0JK0261</drugbatchnumb>
        <drugdosagetext>10 ML, TWICE, 4 HRS APART</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130893-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-GENENTECH-309981</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>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PULMOZYME</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CYSTIC FIBROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100623</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130894-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033957</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>MENINGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090120</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130895-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GENENTECH-309925</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANIBIZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANIBIZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091207</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130896-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0679506A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>100</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIQUITIN CQ 4MG LOZENGE</medicinalproduct>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101010</drugenddate>
        <drugtreatmentduration>101</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130897-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0683378A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>ACCIDENTAL DRUG INTAKE BY CHILD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIQUITIN MINI LOZENGES</medicinalproduct>
        <drugauthorizationnumb>022360</drugauthorizationnumb>
        <drugdosagetext>5LOZ PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130898-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006313</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>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130899-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-10P-056-0687945-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugindication>EPILEPSY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>URBANYL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>EPILEPSY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DONORMYL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG TOXICITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DONORMYL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130900-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PERRIGO-10US015011</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>83.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE SPASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>072096</drugauthorizationnumb>
        <drugdosagetext>400 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSMENORRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130902-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA066628</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 GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE BREAKAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE MALFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLOSTAR</medicinalproduct>
        <drugbatchnumb>0F196A</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>0F196A</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE:18 UNIT(S)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130903-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033832</companynumb>
    <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 ARTERIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101123</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130904-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20101104698</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>HEPATIC NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130909-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US62901</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>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>750 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130910-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US63827</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>2000MG/DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100505</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130911-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010DE17813</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GLOMERULONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CERTICAN</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100414</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AEB071 AEB+GELCAP</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100414</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URBASON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130912-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-AVENTIS-2010SA070524</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHYSICAL DISABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
        <drugauthorizationnumb>018538</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100312</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100312</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100312</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100318</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100318</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>FOR MORE THAN 1 YEAR. DAILY DOSE INCREASED FROM 0.5 MG UP TO 1 MG SINCE 10 DAYS.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100317</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAFLON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130913-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006746</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>PROCRIT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130914-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-US-WYE-H18226010</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.633</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101013</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130915-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-US-WYE-H17364610</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.633</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FLUTTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>25 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130922-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRACCO-000305</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>NEPHROGENIC SYSTEMIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROHANCE</medicinalproduct>
        <drugauthorizationnumb>020131</drugauthorizationnumb>
        <drugindication>ABSCESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060817</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROHANCE</medicinalproduct>
        <drugauthorizationnumb>020131</drugauthorizationnumb>
        <drugindication>NUCLEAR MAGNETIC RESONANCE IMAGING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROHANCE</medicinalproduct>
        <drugauthorizationnumb>020131</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROHANCE</medicinalproduct>
        <drugauthorizationnumb>020131</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNISCAN</medicinalproduct>
        <drugindication>ABSCESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060823</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNISCAN</medicinalproduct>
        <drugindication>NUCLEAR MAGNETIC RESONANCE IMAGING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNISCAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060513</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130923-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0661125A</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>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LEFT VENTRICULAR DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060331</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130924-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0679425A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONGENITAL PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130925-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0680618A</companynumb>
    <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>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART DISEASE CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130926-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0680619A</companynumb>
    <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 SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL GENITOURINARY ABNORMALITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATENT DUCTUS ARTERIOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VESICOURETERIC REFLUX</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugauthorizationnumb>020936</drugauthorizationnumb>
        <drugdosagetext>12.5MG PER DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130927-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0680623A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABO HAEMOLYTIC DISEASE OF NEWBORN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE FOETAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART DISEASE CONGENITAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugindication>PANIC REACTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130928-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0680647A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAL ATRESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE CONGENITAL ABNORMALITIES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>15MG PER DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030709</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130929-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0681147A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>4.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART DISEASE CONGENITAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugauthorizationnumb>020936</drugauthorizationnumb>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN AND MINERAL PRENATAL SUPPLEMENT W/ FOLIC ACID CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130930-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0681438A</companynumb>
    <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 SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL FLOPPY INFANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART DISEASE CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFANTILE APNOEIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL DRUGS AFFECTING FOETUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE CONGENITAL ABNORMALITIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLACENTAL TRANSFUSION SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE RUPTURE OF MEMBRANES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugauthorizationnumb>020936</drugauthorizationnumb>
        <drugdosagetext>25MG IN THE MORNING</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130931-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0681442A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MACROBID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130932-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0682199A</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>ACUTE LUNG INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOPULMONARY DYSPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPHILUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG HYPERINFLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL DRUGS AFFECTING FOETUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE CONGENITAL ABNORMALITIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATENT DUCTUS ARTERIOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE RUPTURE OF MEMBRANES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130933-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0682204A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFANTILE APNOEIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL DRUGS AFFECTING FOETUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLACENTAL TRANSFUSION SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugauthorizationnumb>020936</drugauthorizationnumb>
        <drugdosagetext>25MG IN THE MORNING</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130934-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0684459A</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>CONGENITAL CARDIOVASCULAR ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALLOT'S TETRALOGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL DRUGS AFFECTING FOETUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE CONGENITAL ABNORMALITIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYDACTYLY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEXOFENADINE HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051206</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130935-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0687238A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDUCTION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAILURE TO THRIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALLOT'S TETRALOGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL DRUGS AFFECTING FOETUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATENT DUCTUS ARTERIOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY VALVE STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIGHT VENTRICLE OUTFLOW TRACT OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIGHT VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>30MG TWICE PER DAY</drugdosagetext>
        <drugindication>SOCIAL PHOBIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN AND MINERAL PRENATAL SUPPLEMENT W/ FOLIC ACID CAP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130936-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0747567A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVELOPMENTAL DELAY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENURESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDROCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB ASYMMETRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICTURITION URGENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPASTIC DIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URETHRAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>40MG UNKNOWN</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>500MG THREE TIMES PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000403</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130937-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0802863A</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020201</drugenddate>
        <drugtreatmentduration>246</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130939-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0803589A</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPLANTABLE DEFIBRILLATOR INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050501</drugenddate>
        <drugtreatmentduration>224</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130940-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0803610A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY BYPASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130941-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0803611A</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>CEREBROVASCULAR ACCIDENT</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>20070401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130942-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0803612A</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>CEREBROVASCULAR ACCIDENT</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>20040930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
        <drugtreatmentduration>640</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130943-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0803613A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>CARDIAC MURMUR</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061201</drugenddate>
        <drugtreatmentduration>616</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130944-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0803614A</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>ARTERIAL OCCLUSIVE DISEASE</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>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130945-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0803841A</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>93.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPLANTABLE DEFIBRILLATOR INSERTION</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>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130946-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0803844A</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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</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>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060520</drugenddate>
        <drugtreatmentduration>140</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130947-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0803916A</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>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>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051228</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130948-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0803919A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130949-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0804102A</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130950-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0804105A</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>
      <patientweight>89.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070420</drugenddate>
        <drugtreatmentduration>194</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130952-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0804127A</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
        <drugtreatmentduration>567</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130953-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0804132A</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>
      <patientweight>133.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080217</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130954-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0804147A</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>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130955-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0804151A</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>
      <patientweight>96.4</patientweight>
      <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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071020</drugenddate>
        <drugtreatmentduration>872</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130956-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0804173A</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130957-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0804178A</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060117</drugenddate>
        <drugtreatmentduration>525</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130958-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0804179A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>103.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130959-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0804619A</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050925</drugenddate>
        <drugtreatmentduration>695</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>1000MG TWICE PER DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130960-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0804621A</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>2</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060520</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130961-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0804627A</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>8.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
        <drugtreatmentduration>518</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </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>ZYPREXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130962-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0804639A</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130963-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0853585A</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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROMACTA</medicinalproduct>
        <drugauthorizationnumb>022291</drugauthorizationnumb>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091006</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROMIPLOSTIM</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130964-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0858729A</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>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC PACEMAKER INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC TAMPONADE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSONISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICLE RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070711</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130965-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0863805A</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>ARTERIAL THERAPEUTIC PROCEDURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR GRAFT</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>19990501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130966-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0863849A</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>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATORENAL SYNDROME</reactionmeddrapt>
      </reaction>
      <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>20061023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080204</drugenddate>
        <drugtreatmentduration>470</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130967-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0865593A</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>APHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPARENT DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE BREAKAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOREIGN BODY ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL SEPTUM DEVIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOCAL CORD INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTOLIN HFA</medicinalproduct>
        <drugbatchnumb>9ZP1960,9ZP2568</drugbatchnumb>
        <drugauthorizationnumb>020983</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>BRONCHIAL HYPERREACTIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130968-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0871549A</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>ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPLASTIC LEFT HEART SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATENT DUCTUS ARTERIOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIGHT AORTIC ARCH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130969-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0873800A</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>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130970-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0873830A</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>71.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACTERIAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYCAMTIN</medicinalproduct>
        <drugauthorizationnumb>020671</drugauthorizationnumb>
        <drugdosagetext>7.4MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100603</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugdosagetext>100MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugdosagetext>2MG FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugdosagetext>.5MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>50MG TWICE PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130971-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0875954A</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>91.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugdosagetext>750MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100729</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>75MGM2 WEEKLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100729</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100729</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASTUZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100729</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130972-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0875973A</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>BICUSPID AORTIC VALVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL AORTIC STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130973-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0876541A</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOTRIENT</medicinalproduct>
        <drugbatchnumb>0ZP5376</drugbatchnumb>
        <drugauthorizationnumb>022465</drugauthorizationnumb>
        <drugdosagetext>400MGD PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130974-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0877369A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BINOCULAR EYE MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRANIOSYNOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYPTORCHISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVELOPMENTAL DELAY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INGUINAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICROGNATHIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRABISMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TALIPES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130975-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0877741A</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>69</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS IN DEVICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
        <drugbatchnumb>C214</drugbatchnumb>
        <drugauthorizationnumb>020444</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
        <drugbatchnumb>C457110</drugbatchnumb>
        <drugauthorizationnumb>020444</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130976-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0878763A</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>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID OVERLOAD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART INJURY</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>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080924</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130977-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0882083A</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>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLUMSINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGRAPHIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT RANGE OF MOTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICROANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYASTHENIA GRAVIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEELCHAIR USER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130978-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0885019A</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>
      <reaction>
        <reactionmeddrapt>INJECTION SITE NODULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugbatchnumb>0128</drugbatchnumb>
        <drugauthorizationnumb>021345</drugauthorizationnumb>
        <drugdosagetext>7.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100717</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZEMPLAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130979-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0886531A</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>ARTERIOSCLEROSIS CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130980-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0890082C</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OFATUMUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORAMBUCIL</medicinalproduct>
        <drugauthorizationnumb>010669</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100924</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130981-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0890897A</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>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COAGULATION TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY BLADDER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugauthorizationnumb>021345</drugauthorizationnumb>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETA BLOCKER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTON PUMP INHIBITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130982-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0890932A</companynumb>
    <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>COREG</medicinalproduct>
        <drugbatchnumb>M35DE70</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070430</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130983-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0894679A</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOTRIENT</medicinalproduct>
        <drugauthorizationnumb>022465</drugauthorizationnumb>
        <drugdosagetext>200MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101122</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40MGD PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>160MGD PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugdosagetext>.4MG PER DAY</drugdosagetext>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUSSINEX</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130984-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0894682A</companynumb>
    <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>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130985-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100728</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0894794A</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>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUMATRIPTAN SUCCINATE</medicinalproduct>
        <drugbatchnumb>CMA09001</drugbatchnumb>
        <drugauthorizationnumb>020080</drugauthorizationnumb>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100711</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DRAMAMINE</medicinalproduct>
        <drugindication>NAUSEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130986-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0896402A</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020781</drugauthorizationnumb>
        <drugdosagetext>1TAB AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZENPEP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTERIC ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PSYLLIUM FIBER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130987-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0896795A</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>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS INTESTINAL HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugauthorizationnumb>021345</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIRIS</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NADOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7130988-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0896834A</companynumb>
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    <receiver></receiver>
    <patient>
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        <reactionmeddrapt>DEATH</reactionmeddrapt>
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    <patient>
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        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
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    <receiver></receiver>
    <patient>
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        <reactionmeddrapt>DEATH</reactionmeddrapt>
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        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
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        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
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    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0896866A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131006-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0896867A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131007-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0896868A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131008-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897074A</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>ANAL ATRESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON SULFATETHIAMIN COMPOUND TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN AND MINERAL PRENATAL SUPPLEMENT W/ FOLIC ACID CAP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131009-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897081A</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>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INHALATION THERAPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>45MCG VARIABLE DOSE</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131010-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897084A</companynumb>
    <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>DIABETIC COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131011-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0533467A</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTI-HBC IGG ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTI-HBS ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIARY CIRRHOSIS PRIMARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS A ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS B ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugdosagetext>1000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080815</drugenddate>
        <drugtreatmentduration>85</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASTUZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090514</drugenddate>
        <drugtreatmentduration>357</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131012-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0597199A</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>48.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAZOPANIB</medicinalproduct>
        <drugauthorizationnumb>022465</drugauthorizationnumb>
        <drugdosagetext>800MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090918</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131013-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0637078A</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>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugdosagetext>1000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100224</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>600MGM2 EVERY 3 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100224</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugdosagetext>90MGM2 EVERY 3 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100224</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131014-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0660991A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>51</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <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>20100430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100610</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYKERB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugdosagetext>1250MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100917</drugenddate>
        <drugtreatmentduration>82</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100610</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>2400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100917</drugenddate>
        <drugtreatmentduration>82</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYDOXAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOFERMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100910</drugenddate>
        <drugtreatmentduration>134</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPEMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100715</drugenddate>
        <drugtreatmentduration>77</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131015-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0668370A</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN</medicinalproduct>
        <drugauthorizationnumb>050755</drugauthorizationnumb>
        <drugdosagetext>1Z PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100411</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DALSY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131016-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0674899A</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KIVEXA</medicinalproduct>
        <drugauthorizationnumb>021652</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100516</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN AND CLAVULANATE POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KIVEXA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131017-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0676036A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADRENOCORTICAL INSUFFICIENCY ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugauthorizationnumb>020121</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131018-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0679494A</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>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <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>20090813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091218</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASTUZUMAB</medicinalproduct>
        <drugdosagetext>3000MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081001</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASTUZUMAB</medicinalproduct>
        <drugdosagetext>1440MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASTUZUMAB</medicinalproduct>
        <drugdosagetext>840MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090301</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASTUZUMAB</medicinalproduct>
        <drugdosagetext>1200MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090801</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>3000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091218</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINAL</medicinalproduct>
        <drugdosagetext>6IUAX PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091218</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091204</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>4200MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050301</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131019-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0680140A</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAZOPANIB</medicinalproduct>
        <drugauthorizationnumb>022465</drugauthorizationnumb>
        <drugdosagetext>800MG PER DAY</drugdosagetext>
        <drugindication>CERVIX CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100920</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DINISOR RETARD</medicinalproduct>
        <drugdosagetext>120MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131020-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0682710A</companynumb>
    <primarysource>
      <reportercountry>BULGARIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL VENTRICLE DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION VENTRICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOCARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROBACTER SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPROTEINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACARDIAC THROMBUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOLUME BLOOD DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORAMBUCIL</medicinalproduct>
        <drugauthorizationnumb>010669</drugauthorizationnumb>
        <drugdosagetext>52MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101027</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILURIT</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131021-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0683866A</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAZOPANIB</medicinalproduct>
        <drugauthorizationnumb>022465</drugauthorizationnumb>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100724</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CAROTID ARTERY STENOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIPIDS ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>1.25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131022-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0684842A</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>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugdosagetext>1500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>3500MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
        <drugdosagetext>350MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CREON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVAMINSULFON</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERGENTAN</medicinalproduct>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100906</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE</medicinalproduct>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100726</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
        <drugdosagetext>15DROP THREE TIMES PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100825</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
        <drugdosagetext>10MG AS REQUIRED</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131024-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0686117A</companynumb>
    <primarysource>
      <reportercountry>GREECE</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN</medicinalproduct>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101114</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131025-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0686168A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081201</drugenddate>
        <drugtreatmentduration>118</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131026-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0686184A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GLOSSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugdosagetext>1000MCG PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSOLVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORINAEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOLAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIMAPROST</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131027-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101120</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0686463A</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>84.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAL CANCER</reactionmeddrapt>
      </reaction>
      <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>20060330</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131028-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0686492A</companynumb>
    <primarysource>
      <reportercountry>PAKISTAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugdosagetext>1500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASTUZUMAB</medicinalproduct>
        <drugdosagetext>2MGK WEEKLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>80MGM2 WEEKLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100604</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131029-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0686616A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugauthorizationnumb>020089</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131030-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0686621A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AGITATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101011</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugdosagetext>15MG PER DAY</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DRUG WITHDRAWAL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101016</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROHYPNOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIRNAMIN</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>175MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101012</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131031-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0686625A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <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>20091110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091121</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYKERB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugdosagetext>1000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100103</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>2400MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100103</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYMACKEN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100118</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORGADRONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100118</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131032-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040308</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0686700A</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILATREND</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131033-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050128</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0686706A</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>DILATREND</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131034-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050422</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0686709A</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>DILATREND</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131035-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0686710A</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBODART</medicinalproduct>
        <drugauthorizationnumb>022460</drugauthorizationnumb>
        <drugdosagetext>1CAP PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101122</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TELMISARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131036-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040927</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0686713A</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>DILATREND</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131037-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0686830A</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>TYVERB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugdosagetext>1250MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101026</drugenddate>
        <drugtreatmentduration>64</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101026</drugenddate>
        <drugtreatmentduration>64</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131038-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0686864A</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCAPNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIGHT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SERUM FERRITIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM DISCOLOURED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>POLFENON</medicinalproduct>
        <drugauthorizationnumb>019151</drugauthorizationnumb>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISOPROLOL</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
        <drugdosagetext>.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERINDOPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINPOCETINE</medicinalproduct>
        <drugdosagetext>5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOSMINE + HESPERIDINE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORMOTEROL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
        <drugdosagetext>400MCG TWICE PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORAMPHENICOL</medicinalproduct>
        <drugindication>DYSPNOEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131039-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0686869A</companynumb>
    <primarysource>
      <reportercountry>FINLAND</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>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLIXOTIDE DISKUS</medicinalproduct>
        <drugauthorizationnumb>020833</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131040-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0686871A</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIMBEX</medicinalproduct>
        <drugdosagetext>16MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100914</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTIVA</medicinalproduct>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100914</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugauthorizationnumb>019090</drugauthorizationnumb>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100914</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugdosagetext>.1MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100914</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFAMEZIN</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100914</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EBRANTIL</medicinalproduct>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100914</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100914</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRASTIGMINA</medicinalproduct>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>URINARY RETENTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100914</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131041-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0686886A</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN</medicinalproduct>
        <drugauthorizationnumb>050755</drugauthorizationnumb>
        <drugdosagetext>.5ML PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101112</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131042-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0686888A</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN</medicinalproduct>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugdosagetext>2TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101003</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>1U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>1U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131043-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0686893A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYCAMTIN</medicinalproduct>
        <drugauthorizationnumb>020671</drugauthorizationnumb>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100730</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131044-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>D0069567A</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugauthorizationnumb>021345</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131045-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>Z0005515A</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HELICOBACTER GASTRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugdosagetext>1250MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100714</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugdosagetext>2000MGM2 CYCLIC</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100714</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131046-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>Z0006410A</companynumb>
    <primarysource>
      <reportercountry>CHILE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GW642444</medicinalproduct>
        <drugdosagetext>25MCG PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
        <drugtreatmentduration>55</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100910</drugenddate>
        <drugtreatmentduration>102</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131047-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENZYME-CERZ-1001638</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>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEREZYME</medicinalproduct>
        <drugauthorizationnumb>020367</drugauthorizationnumb>
        <drugdosagetext>3600 U, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GAUCHER'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEREZYME</medicinalproduct>
        <drugauthorizationnumb>020367</drugauthorizationnumb>
        <drugdosagetext>3200 U, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100303</drugenddate>
        <drugtreatmentduration>4132</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEREZYME</medicinalproduct>
        <drugauthorizationnumb>020367</drugauthorizationnumb>
        <drugdosagetext>2000 U, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PULMONARY THROMBOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugdosagetext>70 MG, 1X/W</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugdosagetext>80 MG, Q12HR</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>200 MG, Q12HR</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>100 MCG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZAVESCA</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GAUCHER'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131050-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-12799BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC 75</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020520</drugauthorizationnumb>
        <drugdosagetext>75 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BP PILL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIABETIC PILL</medicinalproduct>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOL PILL</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131051-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-DE-06563GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS COLLAGENOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugauthorizationnumb>020938</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131052-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2010SE55713</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>77.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENISCUS LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMEAR CERVIX ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <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>20090401</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SURGERY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENISCUS LESION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>75 MG IN THE MORNING AND 150 MG AT NIGHT</drugdosagetext>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-TAB</medicinalproduct>
        <drugindication>BLOOD POTASSIUM DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ICAPS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA 3/VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE W/CHONDROITIN SULFATES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
        <drugdosagetext>350 MG DAILY AS NEEDED</drugdosagetext>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
        <drugdosagetext>350 MG DAILY AS NEEDED</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131053-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033827</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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101120</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131055-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-PFIZER INC-2010160233</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERURICAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080710</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131056-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-PFIZER INC-2010159078</companynumb>
    <primarysource>
      <reportercountry>IRELAND</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>LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF INJURIOUS BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131057-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SA-PFIZER INC-2010159932</companynumb>
    <primarysource>
      <reportercountry>SAUDI ARABIA</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>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugauthorizationnumb>021267</drugauthorizationnumb>
        <drugdosagetext>4 MG/KG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BRONCHOPULMONARY ASPERGILLOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131058-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TH-PFIZER INC-2010158095</companynumb>
    <primarysource>
      <reportercountry>THAILAND</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>HEPATIC FAILURE</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>20090622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090922</drugenddate>
        <drugtreatmentduration>93</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131059-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-PFIZER INC-2010148232</companynumb>
    <primarysource>
      <reportercountry>TURKEY</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>BLOOD CORTICOTROPHIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLUCOCORTICOIDS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>010151</drugauthorizationnumb>
        <drugdosagetext>200 MG/DAILY</drugdosagetext>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugdosagetext>15 MG/M2/DAY IN THREE DIVIDED DOSES</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDROCORTISONE</medicinalproduct>
        <drugdosagetext>0.1 MG/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131060-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-PFIZER INC-2010158886</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugauthorizationnumb>021267</drugauthorizationnumb>
        <drugdosagetext>400 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ASPERGILLOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080917</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugauthorizationnumb>021267</drugauthorizationnumb>
        <drugdosagetext>200 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081019</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEICOPLANIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081019</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081019</drugenddate>
        <drugtreatmentduration>52</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN K TAB</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081019</drugenddate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081019</drugenddate>
        <drugtreatmentduration>46</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLORIC ^FAES^</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081019</drugenddate>
        <drugtreatmentduration>74</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081019</drugenddate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RULID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081023</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131061-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-PFIZER INC-2010159805</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugauthorizationnumb>021267</drugauthorizationnumb>
        <drugdosagetext>450 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ASPERGILLOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071224</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugauthorizationnumb>021267</drugauthorizationnumb>
        <drugdosagetext>300 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080120</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNERCID</medicinalproduct>
        <drugdosagetext>550 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080123</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>30 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080125</drugenddate>
        <drugtreatmentduration>64</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUTROGIN</medicinalproduct>
        <drugdosagetext>250 UG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>BONE MARROW FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080123</drugenddate>
        <drugtreatmentduration>63</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODEOXYCHOLIC ACID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080126</drugenddate>
        <drugtreatmentduration>62</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080126</drugenddate>
        <drugtreatmentduration>62</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugdosagetext>10 IU, 1X/DAY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080119</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131062-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2010158986</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100828</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, 4X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>1 MG, 2X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131063-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENZYME-CERZ-1001674</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>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEREZYME</medicinalproduct>
        <drugauthorizationnumb>020367</drugauthorizationnumb>
        <drugdosagetext>3600 U, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GAUCHER'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEREZYME</medicinalproduct>
        <drugauthorizationnumb>020367</drugauthorizationnumb>
        <drugdosagetext>3600 U, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100216</drugenddate>
        <drugtreatmentduration>4117</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEREZYME</medicinalproduct>
        <drugauthorizationnumb>020367</drugauthorizationnumb>
        <drugdosagetext>2000 U, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101012</drugenddate>
        <drugtreatmentduration>224</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugdosagetext>70 MG, 1X/W</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugdosagetext>80 MG, Q12HR</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>200 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZAVESCA</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GAUCHER'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131064-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006554</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>APPENDIX DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UMBILICAL HERNIA</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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131065-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006395</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS STAPHYLOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1017577</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061220</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131068-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033757</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>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADCIRCA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131069-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENZYME-THYM-1002113</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>ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES SIMPLEX</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TRANSPLANT REJECTION</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
        <drugindication>CHOLECYSTITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPINEPHRINE</medicinalproduct>
        <drugindication>HAEMODYNAMIC INSTABILITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOREPINEPHRINE</medicinalproduct>
        <drugindication>HAEMODYNAMIC INSTABILITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOPRESSIN</medicinalproduct>
        <drugindication>HAEMODYNAMIC INSTABILITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugdosagetext>5 MG/KG, BID</drugdosagetext>
        <drugindication>TRANSPLANT REJECTION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugdosagetext>1.25 MG/KG, BID</drugdosagetext>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugdosagetext>0.2 MG/KG, UNK</drugdosagetext>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugdosagetext>375 MG/M2, UNK</drugdosagetext>
        <drugindication>TRANSPLANT REJECTION</drugindication>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNE GLOBULIN NOS</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TRANSPLANT REJECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131070-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033413</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>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090805</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTAVIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131075-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-GENENTECH-310109</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>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>600 MG, Q21D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100713</drugenddate>
        <drugtreatmentduration>57</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131076-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-GENZYME-POMP-1001132</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>8.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVELOPMENTAL DELAY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEARING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYOZYME</medicinalproduct>
        <drugdosagetext>14 MG/KG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLYCOGEN STORAGE DISEASE TYPE II</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYOZYME</medicinalproduct>
        <drugdosagetext>20 MG/KG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYOZYME</medicinalproduct>
        <drugdosagetext>10 MG/KG, QW</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHISTAMINES</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROID NOS</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131077-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA070806</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>DEVICE MALFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLOSTAR</medicinalproduct>
        <drugbatchnumb>0F172A</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>0F172A</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131078-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101120</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20101107606</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACROCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</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>FEROGRAD</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERESTA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131079-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15264112</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>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugbatchnumb>09C00208A</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100813</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100813</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100813</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DEEP VEIN THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100811</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PULMONARY EMBOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100811</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100802</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131081-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010154350</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</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>CORINAEL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>GOUT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131082-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010152241</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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugauthorizationnumb>019787</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TELMISARTAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131083-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010153715</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>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIGAN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOPRIL</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE</medicinalproduct>
        <drugdosagetext>88 UG, UNK</drugdosagetext>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131084-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010153648</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>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELCHOL</medicinalproduct>
        <drugdosagetext>625 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>0.112 MG, UNK</drugdosagetext>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131085-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENZYME-RENA-1000933</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 NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPHOSPHATAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RENVELA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022127</drugauthorizationnumb>
        <drugdosagetext>1.6 G, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100920</drugenddate>
        <drugtreatmentduration>83</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RENVELA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100630</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131086-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-TEVA-256822ISR</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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 INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC URAEMIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugauthorizationnumb>065154</drugauthorizationnumb>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugdosagetext>1MG/0.5MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131093-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-TEVA-255119ISR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</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>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZILECT</medicinalproduct>
        <drugauthorizationnumb>021641</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COD LIVEROIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULPHUR OLIGOSOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SELENIUM OLIGOSOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MANGANESE COPPER OLIGOSOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBES NINGRUM ESSENCE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HARPAGOPHYTUM POWDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENTIANA LUTEA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELISSA OFFICINALIS</medicinalproduct>
        <drugdosagetext>13-9-2010</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROPINIROLE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM PIDOLATE</medicinalproduct>
        <drugdosagetext>13-9-2010</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARNICA 9 CH</medicinalproduct>
        <drugdosagetext>13-9-2010</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUSTOX 9CH</medicinalproduct>
        <drugdosagetext>13-9-2010</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131094-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033926</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090626</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131095-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-ABBOTT-09P-143-0562139-00</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 TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR ORAL SOLUTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020659</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090305</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMPRENAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090305</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBAL MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABACAVIR SULPHATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090305</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090305</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-TRIMOXAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090305</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS GLUCONATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090305</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131096-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011005719</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGAMENT RUPTURE</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>7131103-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011005720</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>REHABILITATION THERAPY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131104-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011005727</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>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131105-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011005709</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>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <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>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131106-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011005648</companynumb>
    <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 ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITRACAL + D</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUMS /00108001/</medicinalproduct>
        <drugdosagetext>UNK, OCCASIONALLY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLESTEROL</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131107-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011005624</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A719441C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugtreatmentduration>213</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131108-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011005671</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>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131109-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011005700</companynumb>
    <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>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A719438D</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugindication>TREMOR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN LOW</medicinalproduct>
        <drugdosagetext>1 D/F, DAILY (1/D)</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131110-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201007002350</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.887</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL RECESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMOBILE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSITIVITY OF TEETH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A713107C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A713107C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIDOPHILUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAXSEED OIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131111-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011005668</companynumb>
    <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>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131112-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011005708</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>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131113-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ELI_LILLY_AND_COMPANY-ES201011005393</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>48.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A72604C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>1 D/F, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEGURIL</medicinalproduct>
        <drugdosagetext>40 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NATECAL D</medicinalproduct>
        <drugdosagetext>1 D/F, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERPLEX</medicinalproduct>
        <drugdosagetext>40 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLI DOCE</medicinalproduct>
        <drugdosagetext>1 D/F, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPOTEN</medicinalproduct>
        <drugdosagetext>1 D/F, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131114-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-ELI_LILLY_AND_COMPANY-CH201010002386</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100928</drugenddate>
        <drugtreatmentduration>70</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIMAGON-D 3</medicinalproduct>
        <drugdosagetext>1 D/F, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>600 IU, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>300 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORASEMID</medicinalproduct>
        <drugdosagetext>5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORASEMID</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAMON</medicinalproduct>
        <drugdosagetext>240 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EICOSAPEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131115-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXBR2010US02012</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYMPANIC MEMBRANE PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYMPANOPLASTY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNITROPE</medicinalproduct>
        <drugauthorizationnumb>021426</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SURGERY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101122</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131116-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2010GB10044</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>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS OF PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVE BIRTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE LABOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIHYDROCODEINE (NGX)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIHYDROCODEINE (NGX)</medicinalproduct>
        <drugdosagetext>30 MG, QD TO TID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugauthorizationnumb>070663</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE (NGX)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIPIPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIPIPRAZOLE</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORETHISTERONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORETHISTERONE</medicinalproduct>
        <drugdosagetext>350 UG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORAMPHENICOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBAZAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPICILLIN SODIUM/SULBACTAM SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NUTRITION SUPPLEMENTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131117-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2010PL13209</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLOGICAL EYELID DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL HYPOMOTILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVODOPA+CARBIDOPA (NGX)</medicinalproduct>
        <drugauthorizationnumb>073586</drugauthorizationnumb>
        <drugdosagetext>1 DF/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSONISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100619</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVODOPA+CARBIDOPA (NGX)</medicinalproduct>
        <drugauthorizationnumb>073586</drugauthorizationnumb>
        <drugdosagetext>2 DF/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100820</drugenddate>
        <drugtreatmentduration>62</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVODOPA+CARBIDOPA (NGX)</medicinalproduct>
        <drugauthorizationnumb>073586</drugauthorizationnumb>
        <drugdosagetext>3 DF/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100903</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVODOPA+CARBIDOPA (NGX)</medicinalproduct>
        <drugauthorizationnumb>073586</drugauthorizationnumb>
        <drugdosagetext>2 DF/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100905</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVODOPA+CARBIDOPA (NGX)</medicinalproduct>
        <drugauthorizationnumb>073586</drugauthorizationnumb>
        <drugdosagetext>1 DF/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100907</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugdosagetext>4,5 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>2,5 MG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCOR</medicinalproduct>
        <drugdosagetext>5 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONONIT</medicinalproduct>
        <drugdosagetext>40 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COENZYME Q10</medicinalproduct>
        <drugdosagetext>+ LECITHIN 30 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THERAPEUTIC MULTIVITAMINS</medicinalproduct>
        <drugdosagetext>1 TABLET/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIO-MARIN</medicinalproduct>
        <drugdosagetext>570 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALIPOZ</medicinalproduct>
        <drugdosagetext>391 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHOSPHATIDYL SERINE</medicinalproduct>
        <drugdosagetext>300 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131119-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2010US13125</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORGANISING PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA LEGIONELLA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE (NGX)</medicinalproduct>
        <drugauthorizationnumb>080399</drugauthorizationnumb>
        <drugdosagetext>4 MG, Q6H</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CENTRAL NERVOUS SYSTEM LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131120-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2010US13120</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS PARALYTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METAMYELOCYTE COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMOCHROMIC NORMOCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBLITERATIVE BRONCHIOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRONGYLOIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE (NGX)</medicinalproduct>
        <drugauthorizationnumb>080399</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugdosagetext>3 TIMES A WEEK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPEUTICS NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131121-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2010GB11018</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>
      <patientweight>74</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR ACIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugauthorizationnumb>075985</drugauthorizationnumb>
        <drugdosagetext>850 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100910</drugenddate>
        <drugtreatmentduration>4636</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD GLUCOSE INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131122-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2010GB13026</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALENDRONIC ACID (NGX)</medicinalproduct>
        <drugauthorizationnumb>075871</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131124-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2010GB13028</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>090029</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100806</drugenddate>
        <drugtreatmentduration>6058</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100806</drugenddate>
        <drugtreatmentduration>1510</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131125-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXBR2010US01998</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNITROPE</medicinalproduct>
        <drugbatchnumb>BA6075</drugbatchnumb>
        <drugauthorizationnumb>021426</drugauthorizationnumb>
        <drugdosagetext>2.8 MG, QD</drugdosagetext>
        <drugindication>DWARFISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131126-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2010GB10043</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>7.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVE BIRTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIHYDROCODEINE (NGX)</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIHYDROCODEINE (NGX)</medicinalproduct>
        <drugdosagetext>MATERNAL DOSE. 30 MG, QD TO TID</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugauthorizationnumb>070663</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE (NGX)</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugdosagetext>400 MG, BID (MATERNAL DOSE)</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIPIPRAZOLE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIPIPRAZOLE</medicinalproduct>
        <drugdosagetext>MATERNAL DOSE: 30 MG, UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORETHISTERONE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORETHISTERONE</medicinalproduct>
        <drugdosagetext>MATERNAL DOSE. 350 UG, UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORAMPHENICOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBAZAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPICILLIN SODIUM/SULBACTAM SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NUTRITION SUPPLEMENTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131127-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-GENENTECH-310162</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1 DF, 1/MONTH</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTIDE</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>THEOBID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131128-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20091201881</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHIECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COR PULMONALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMPONI</medicinalproduct>
        <drugdosagetext>RECEIVED 1 DOSE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131132-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-A03200905059</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>ELECTROCARDIOGRAM ST SEGMENT ELEVATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIPHOSPHOLIPID ANTIBODIES POSITIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131133-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GENZYME-FABR-1001498</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FABRAZYME</medicinalproduct>
        <drugdosagetext>1 MG/KG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FABRY'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FABRAZYME</medicinalproduct>
        <drugdosagetext>75 MG, Q2W</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FABRAZYME</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORASEMID</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XIPAMID</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLOPIN</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131138-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0032952</companynumb>
    <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>NERVE COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100831</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131139-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2010SE55806</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT DISLOCATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE 320 MCG, BID</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>EMPHYSEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131140-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-DE-06613DE</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131141-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-DE-06449DE</companynumb>
    <primarysource>
      <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>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIFROL</medicinalproduct>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugdosagetext>1X3 TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MADOPAR</medicinalproduct>
        <drugdosagetext>1X3 TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131142-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-DE-05711GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAILURE TO ANASTOMOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUTURE RELATED COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugauthorizationnumb>020938</drugauthorizationnumb>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>1DF</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LACUNAR INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MADOPAR</medicinalproduct>
        <drugdosagetext>3DF</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSONISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugdosagetext>3DF</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugdosagetext>3DF</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>1DF / PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPINAL OSTEOARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131143-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2009-BP-04814BP</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLIND (DABIGATRAN)</medicinalproduct>
        <drugauthorizationnumb>063267</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLIND (DABIGATRAN)</medicinalproduct>
        <drugauthorizationnumb>063267</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MADOPAR</medicinalproduct>
        <drugdosagetext>125 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARKIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070829</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARLODEL</medicinalproduct>
        <drugdosagetext>11.25 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMSULOSIN CAPSULES</medicinalproduct>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugdosagetext>0.4 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070829</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugdosagetext>15 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CACO3</medicinalproduct>
        <drugdosagetext>1500 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070829</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTILIUM-M</medicinalproduct>
        <drugdosagetext>38.16 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081017</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131144-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-AU-00819AU</companynumb>
    <primarysource>
      <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>LARYNGEAL CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131145-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC.-2010-RO-01554RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN STEM SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugauthorizationnumb>077214</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131146-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028379</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>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131147-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-10P-028-0685295-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</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>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>6002165</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090728</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>6002165</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>2.5MG, 7 TABLETS WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugdosagetext>35 MG WEEKLY</drugdosagetext>
        <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>PLAQUENIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>5MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONICOTINIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYCOBACTERIUM TUBERCULOSIS COMPLEX TEST POSITIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131148-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-HQWYE072529JAN03</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>0.625 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131149-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-PFIZER INC-2010158159</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugauthorizationnumb>050670</drugauthorizationnumb>
        <drugdosagetext>500 MG, TOTAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101105</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131150-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010153826</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131151-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010153842</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>25 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST HERPETIC NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100923</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100909</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100924</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131152-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-PFIZER INC-2010147114</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</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>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugauthorizationnumb>011459</drugauthorizationnumb>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131153-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2010156518</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>114</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMSIROLIMUS</medicinalproduct>
        <drugauthorizationnumb>022088</drugauthorizationnumb>
        <drugdosagetext>25 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101108</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131154-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-PFIZER INC-2010152912</companynumb>
    <primarysource>
      <reportercountry>NORWAY</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>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugbatchnumb>04860</drugbatchnumb>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>GLAUCOMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBYL-E</medicinalproduct>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROXIN</medicinalproduct>
        <drugdosagetext>EVERY OTHER DAY</drugdosagetext>
        <drugindication>GOITRE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131155-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2010024976</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DALACINE</medicinalproduct>
        <drugauthorizationnumb>050441</drugauthorizationnumb>
        <drugdosagetext>10 ML</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA PROCEDURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100212</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DALACINE</medicinalproduct>
        <drugauthorizationnumb>050441</drugauthorizationnumb>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131156-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2010157954</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</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>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131157-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-PFIZER INC-2010154183</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BOI K</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPARTIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELEBLOC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131158-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2010157636</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>DEMENTIA ALZHEIMER'S TYPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FRONTAL</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugdosagetext>1 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100824</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131159-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-PFIZER INC-2010153974</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST HERPETIC NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131160-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2009205483</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>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131164-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-BAXTER-2010BH028855</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131165-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GENENTECH-310296</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>0.05 ML, UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090709</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VISUDYNE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GATIFLOXACIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131170-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH027875</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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131171-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH027980</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>BLOODY PERITONEAL EFFLUENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131172-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028460</companynumb>
    <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 POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131173-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028696</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>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131174-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028771</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131175-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028819</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>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131176-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028865</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101121</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131177-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7016223</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080625</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNSPECIFIED MEDICATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131178-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DZ-PFIZER INC-2010080292</companynumb>
    <primarysource>
      <reportercountry>ALGERIA</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAHOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>80 MG, 1X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100603</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugdosagetext>0.8 ML, 2X/DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131179-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-PFIZER INC-2010154381</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYCYTHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>150 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100915</drugenddate>
        <drugtreatmentduration>92</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUTIROX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MODURETIC 5-50</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131180-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2010154242</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131181-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2010154414</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131185-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7029477</companynumb>
    <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>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHRYOXINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131186-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010005662</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLIGHTED OVUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050220</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131187-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010005694</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050220</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131188-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101109009</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>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugdosagetext>SECOND INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugdosagetext>IN 0.8 ML (PEN THERAPY)</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131189-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20101103406</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULPHASALAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131190-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ABBOTT-10P-013-0686756-00</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCRIN DEPOT 11.25 MG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020708</drugauthorizationnumb>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BICALUTAMIDE</medicinalproduct>
        <drugdosagetext>FORM STRENGTH: 50MG</drugdosagetext>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071031</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131191-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-NOVOPROD-318306</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOMICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIXTARD HUMAN 70/30</medicinalproduct>
        <drugauthorizationnumb>019991</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131192-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NOVOPROD-319105</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugbatchnumb>N/A</drugbatchnumb>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>0.3 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101023</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugbatchnumb>N/A</drugbatchnumb>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>0.6 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITOROL</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIGMART</medicinalproduct>
        <drugdosagetext>15 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugdosagetext>15 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIYARISAN BM</medicinalproduct>
        <drugdosagetext>3 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRAMALIL</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMICRON</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDE                          /00571901/</medicinalproduct>
        <drugdosagetext>12 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIBENOL</medicinalproduct>
        <drugdosagetext>150 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131193-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-NOVOPROD-319104</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>VICTOZA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101120</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131194-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-NOVOPROD-318309</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VICTIM OF HOMICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIXTARD HUMAN 70/30</medicinalproduct>
        <drugauthorizationnumb>019991</drugauthorizationnumb>
        <drugindication>OFF LABEL USE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131195-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-NOVOPROD-318308</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIC COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VICTIM OF HOMICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIXTARD HUMAN 70/30</medicinalproduct>
        <drugauthorizationnumb>019991</drugauthorizationnumb>
        <drugindication>OFF LABEL USE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131196-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-NOVOPROD-315508</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugbatchnumb>NA</drugbatchnumb>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>0.6 MG, QD</drugdosagetext>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100618</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>36 U, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>80 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS HCT</medicinalproduct>
        <drugdosagetext>80 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugdosagetext>MR</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>12.5 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>300 MG, QD, HS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>400 MG, PRN, Q4H</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131197-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-NOVOPROD-318307</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VICTIM OF HOMICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIXTARD HUMAN 70/30</medicinalproduct>
        <drugauthorizationnumb>019991</drugauthorizationnumb>
        <drugindication>OFF LABEL USE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131198-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-NOVOPROD-317906</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VICTIM OF HOMICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIXTARD HUMAN 70/30</medicinalproduct>
        <drugauthorizationnumb>019991</drugauthorizationnumb>
        <drugindication>OFF LABEL USE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131199-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-NOVOPROD-315760</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>134</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BENIGN SALIVARY GLAND NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</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>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100310</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>1000 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>10 UNK, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131200-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-307961</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>87.528</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</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>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRANDIN</medicinalproduct>
        <drugdosagetext>2 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100325</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugdosagetext>25 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
        <drugdosagetext>50MG, QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
        <drugdosagetext>PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>160 MG QAM + 80 MG QPM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugdosagetext>500 MG, 3 PO QHS</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>SYNTHROID</medicinalproduct>
        <drugdosagetext>0.088 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>1200 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131201-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NOVOPROD-319222</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTI-INSULIN ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEMPHIGOID</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugbatchnumb>NA</drugbatchnumb>
        <drugauthorizationnumb>021536</drugauthorizationnumb>
        <drugdosagetext>30 U, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID CHU FLEXPEN</medicinalproduct>
        <drugbatchnumb>NA</drugbatchnumb>
        <drugdosagetext>96 U, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLON                        /00016201/</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131202-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7029544</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMYOTROPHIC LATERAL SCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131205-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7029476</companynumb>
    <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>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131206-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2010154444</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131207-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2010154446</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131208-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2010154434</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131209-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2010154439</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131210-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2010154450</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131214-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CG-MERCK-1011USA03309</companynumb>
    <primarysource>
      <reportercountry>CONGO</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL ASYMMETRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ONCHOCERCIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101023</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131215-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0705USA03634</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>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBMANDIBULAR MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
        <drugtreatmentduration>2746</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000201</drugenddate>
      </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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
        <drugtreatmentduration>2746</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131216-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CG-MERCK-1011USA03249</companynumb>
    <primarysource>
      <reportercountry>CONGO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ONCHOCERCIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101015</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131217-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0708USA02440</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>85</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COSTOCHONDRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DISPLACEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOOSE TOOTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070201</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
        <drugtreatmentduration>1097</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131218-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-1011FRA00087</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN LYSINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131219-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-MERCK-1011USA03501</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE I HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOROXIN</medicinalproduct>
        <drugauthorizationnumb>019384</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101008</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131220-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CG-MERCK-1011USA03307</companynumb>
    <primarysource>
      <reportercountry>CONGO</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ONCHOCERCIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101022</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131221-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1011USA02109</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>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131222-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CG-MERCK-1011USA03247</companynumb>
    <primarysource>
      <reportercountry>CONGO</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ONCHOCERCIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100710</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131223-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CG-MERCK-1011USA03253</companynumb>
    <primarysource>
      <reportercountry>CONGO</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>32</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101024</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131224-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-MERCK-1010USA00095</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENITAL HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT CREPITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TESTICULAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
        <drugauthorizationnumb>020788</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ALOPECIA</drugindication>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131225-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-1011DEU00135</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL CONDITION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORTHALIDONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131226-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1011USA03299</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>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>021445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131227-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-MERCK-1011ESP00013</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>TIBIA FRACTURE</reactionmeddrapt>
      </reaction>
      <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>20101101</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131228-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0903GBR00045</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>EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131229-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-1011DEU00048</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugauthorizationnumb>021687</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131230-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-1011GBR00016</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>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugauthorizationnumb>019558</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONGLYZA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100526</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131231-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-14845861</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPODYSTROPHY ACQUIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100804</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISENTRESS</medicinalproduct>
        <drugdosagetext>TABS</drugdosagetext>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090429</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTELENCE</medicinalproduct>
        <drugindication>ANTIRETROVIRAL THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELSENTRI</medicinalproduct>
        <drugindication>ANTIRETROVIRAL THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131232-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-15270994</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>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPRYCEL</medicinalproduct>
        <drugauthorizationnumb>021986</drugauthorizationnumb>
        <drugdosagetext>3DEC08-13JAN09.DOSE REDUCED TO 80MG 14JAN09-UNTIL NOW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMICRON</medicinalproduct>
        <drugdosagetext>FROM LONG TIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
        <drugdosagetext>1DF=3 TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMIX</medicinalproduct>
        <drugdosagetext>1DF=1 TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATIC ADENOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131233-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-BRISTOL-MYERS SQUIBB COMPANY-13950837</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UROSEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORENCIA</medicinalproduct>
        <drugdosagetext>49;16OT,12JN,9JL,3AG,6S,1OT07,24JA08,21F,20MR,18AP,19MY,13JN,11JL,15AUG,12SEP,7OCT,4N,25NV08,25NV10</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORENCIA</medicinalproduct>
        <drugdosagetext>49;16OT,12JN,9JL,3AG,6S,1OT07,24JA08,21F,20MR,18AP,19MY,13JN,11JL,15AUG,12SEP,7OCT,4N,25NV08,25NV10</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL NO 1</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRAVOL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AXERT</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131234-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-BRISTOL-MYERS SQUIBB COMPANY-15398944</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
        <drugindication>TYPE IIA HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131235-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-15284003</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>BLADDER DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPRYCEL</medicinalproduct>
        <drugauthorizationnumb>021986</drugauthorizationnumb>
        <drugdosagetext>STARTED AS 50MG IN SEP-OCT 2009 THEN TOOK 100MG JAN-FEB10</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHIMAX</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131236-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15312275</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED: SAXAGLIPTIN</medicinalproduct>
        <drugauthorizationnumb>022350</drugauthorizationnumb>
        <drugdosagetext>LAST DOSE 22SEP2010</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100922</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugauthorizationnumb>020357</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIABETA</medicinalproduct>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100819</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>1DF={100MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPERTENSION MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131237-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15399579</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>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ODYNOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>LAST DOSE:02AUG2010 (70D)</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABRAXANE</medicinalproduct>
        <drugdosagetext>LAST DOSE:09AUG2010 (91D)</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100510</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>LAST DOSE:12JUL2010 (91D)</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE AND ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131238-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-15408560</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>CALCULUS URINARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131239-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-15409220</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131241-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BRISTOL-MYERS SQUIBB COMPANY-15409337</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131242-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-BRISTOL-MYERS SQUIBB COMPANY-15411515</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOLBUTAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131247-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BRISTOL-MYERS SQUIBB COMPANY-15409246</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131248-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-BRISTOL-MYERS SQUIBB COMPANY-15410327</companynumb>
    <primarysource>
      <reportercountry>MEXICO</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>APROVEL TABS 150 MG</medicinalproduct>
        <drugauthorizationnumb>020757</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131249-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15410418</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>67</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugauthorizationnumb>009218</drugauthorizationnumb>
        <drugdosagetext>1DF=MONDAY THRU THURSDAY 7.5MG AND FRIDAY, SATURDAY, AND SUNDAY 5MG DOSE</drugdosagetext>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VITAMIN K TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131250-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15411242</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORENCIA</medicinalproduct>
        <drugdosagetext>2 TREATMENTS ONE ON 22OCT2010 AND 05NOV2014</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131251-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-BRISTOL-MYERS SQUIBB COMPANY-15411523</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFIBRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131252-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-RA-00301RA</companynumb>
    <primarysource>
      <qualification>1</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>PRADAXA</medicinalproduct>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131253-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-RA-00300RA</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</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>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131254-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-12768BP</companynumb>
    <primarysource>
      <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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101030</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020520</drugauthorizationnumb>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131255-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MA-ROXANE LABORATORIES, INC.-2010-RO-01559RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACARODERMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugauthorizationnumb>040032</drugauthorizationnumb>
        <drugindication>SCLERODERMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugauthorizationnumb>074069</drugauthorizationnumb>
        <drugindication>SCLERODERMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131256-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GENENTECH-310298</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>0.05 ML, UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VISUDYNE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GATIFLOXACIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131257-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033912</companynumb>
    <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>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101114</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131258-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010158111</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>ZITHROMAC</medicinalproduct>
        <drugauthorizationnumb>050670</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAC</medicinalproduct>
        <drugauthorizationnumb>050670</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101122</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131259-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010156216</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.458</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENIERE'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugdosagetext>0.25 MG/DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC ATTACK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugdosagetext>0.5 MG/DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugdosagetext>1 MG/DAILY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131261-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010159289</companynumb>
    <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>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131262-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2010157540</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>HYPERLACTACIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugauthorizationnumb>021130</drugauthorizationnumb>
        <drugdosagetext>600 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100907</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OFLOCET</medicinalproduct>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100816</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LERCANIDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APROVEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDENSIEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAHOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131263-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-PFIZER INC-2010139208</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRANKIMAZIN</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugdosagetext>1 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANDRAL</medicinalproduct>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugdosagetext>50 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZAMENE</medicinalproduct>
        <drugdosagetext>30 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131264-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010153802</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>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>150 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPINAL COLUMN STENOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131265-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-HQWYE999803OCT03</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>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131266-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010159204</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>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugauthorizationnumb>021131</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMEROL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131272-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-TEVA-2009R0504128</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM DIFFICILE COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugauthorizationnumb>089081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>MOXIFLOXACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORMOTEROL FUMARATE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIOTROPIUM BROMIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 5 (E2B UNIT: 003)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131273-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PH-EISAI INC.-E2090-01294-SPO-PH</companynumb>
    <primarysource>
      <reportercountry>PHILIPPINES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZONEGRAN</medicinalproduct>
        <drugauthorizationnumb>020789</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100823</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ZONEGRAN</medicinalproduct>
        <drugauthorizationnumb>020789</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100827</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100817</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131276-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-GENENTECH-287708</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1 UNK, Q14D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090730</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1 UNK, Q14D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090730</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED DOXORUBICIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1 UNK, Q14D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090730</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1 UNK, Q14D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090730</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1 UNK, Q14D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090730</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1 UNK, Q14D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090730</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED VINCRISTINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1 UNK, Q14D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090730</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED DOXORUBICIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED VINCRISTINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED DOXORUBICIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED VINCRISTINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED DOXORUBICIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED VINCRISTINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091217</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091217</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED DOXORUBICIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091217</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091217</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091217</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091217</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED VINCRISTINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091217</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED DOXORUBICIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED VINCRISTINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100312</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100312</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED DOXORUBICIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100312</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100312</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100312</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100312</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED VINCRISTINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100312</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>600 MG, Q14D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090730</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>600 MG, Q14D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>600 MG, Q14D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>1200 MG, Q14D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090730</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>1200 MG, Q14D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN</medicinalproduct>
        <drugdosagetext>80 MG, Q14D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090730</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN</medicinalproduct>
        <drugdosagetext>80 MG, Q14D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN</medicinalproduct>
        <drugdosagetext>80 MG, Q14D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>500 MG, Q14D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090730</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>500 MG, Q14D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>500 MG, Q14D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>2 MG, Q14D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090730</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>2 MG, Q14D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>2 MG, Q14D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR 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>LORAZEPAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM + SULFAMETHOXAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131277-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-10P-028-0636868-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081023</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>CHOLESTYRAMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091119</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>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</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>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>ASCORBIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131278-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0681594-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXIMETHASONE CREAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZYL PEROXIDE</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131279-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PFIZER INC-2010154550</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTONIC BLADDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131280-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010156059</companynumb>
    <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>DYSLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>600 MG</drugdosagetext>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131281-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CL-PFIZER INC-2010155892</companynumb>
    <primarysource>
      <reportercountry>CHILE</reportercountry>
      <qualification>2</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>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131288-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-SHIRE-SPV1-2010-02064</companynumb>
    <primarysource>
      <reportercountry>MEXICO</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>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELAPRASE</medicinalproduct>
        <drugdosagetext>0.5 MG/KG, UNK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>MUCOPOLYSACCHARIDOSIS II</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100818</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131289-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7016253</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOTIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100827</drugenddate>
        <drugtreatmentduration>154</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131291-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20081001</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-CELGENEUS-056-21880-08100231</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131292-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH000146</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>140</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE LEFT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AZOTAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL CIRCULATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROMECHANICAL DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPARIN-INDUCED THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUPIL FIXED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>087095</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CATHETERISATION CARDIAC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>087095</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STENT PLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>087095</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>087095</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>087092</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>087092</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>097079</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>097079</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>087092</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>087092</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>087095</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>087095</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>097079</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>097079</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>087092</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>087092</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>097079</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>097079</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CATHETERISATION CARDIAC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STENT PLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</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>VICODIN</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>ESOMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugadministrationroute>065</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>2</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</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>CAPTOPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOBUTAMINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>5% DEXTROSE INJECTION</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOREPINEPHRINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYLEPHRINE HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULFATE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131293-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2010148849</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANADIN PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANADIN IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131294-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010061668</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>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHILDREN'S MOTRIN</medicinalproduct>
        <drugauthorizationnumb>020589</drugauthorizationnumb>
        <drugdosagetext>300 MG, EVERY 6 HOURS EVERYDAY FOR 3 WEEKS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
        <drugtreatmentduration>183</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugdosagetext>200 MG,1IN1 AS NEEDED</drugdosagetext>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131295-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH005743</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>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AZOTAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC DIATHESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPARIN-INDUCED THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOTOR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR GRAFT COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR GRAFT OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DEHISCENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HAEMODIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080229</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CATHETER PLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080229</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INTRAVENOUS CATHETER MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080229</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080303</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080303</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080303</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080304</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080304</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080304</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080318</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080318</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080318</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080311</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080311</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080311</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080311</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080311</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080311</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080318</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080318</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080318</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080419</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080419</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080419</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080305</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080305</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080305</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080306</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080306</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080306</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080307</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080307</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080307</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080312</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080312</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080312</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080419</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080419</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080419</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080229</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080229</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080229</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080313</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080313</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080313</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080311</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</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>METOPROLOL</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>AVELOX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABETALOL HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESMOPRESSIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTIVASE ^ROCHE^</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFAZOLIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAPAVERINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESZOPICLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE HCL 25MG TAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131297-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7029364</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENTEROCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL LAMINECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071108</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131298-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7025574</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugbatchnumb>Y15A7720</drugbatchnumb>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100917</drugenddate>
        <drugtreatmentduration>702</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131299-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-231191J09USA</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>CUSHING'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091223</drugenddate>
        <drugtreatmentduration>219</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED CHOLESTEROL MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED THYROID MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COGNITIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131300-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7023687</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>127</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131301-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2010DK13031</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHIOLOALVEOLAR CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE SANDOZ (NGX)</medicinalproduct>
        <drugauthorizationnumb>090029</drugauthorizationnumb>
        <drugdosagetext>15 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SERONEGATIVE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080227</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131302-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2010IE13128</companynumb>
    <primarysource>
      <reportercountry>IRELAND</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>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC URAEMIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLASMAPHERESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>TACROLIMUS (NGX)</medicinalproduct>
        <drugdosagetext>3 MG, BID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>TACROLIMUS (NGX)</medicinalproduct>
        <drugdosagetext>1 MG/0.5 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugauthorizationnumb>065136</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugdosagetext>75 MG DAILY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TINZAPARIN</medicinalproduct>
        <drugindication>PULMONARY EMBOLISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131303-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2010TR13122</companynumb>
    <primarysource>
      <reportercountry>TURKEY</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>AORTIC VALVE REPLACEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MECHANICAL VENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugauthorizationnumb>070889</drugauthorizationnumb>
        <drugdosagetext>TWICE A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFAMPICIN</medicinalproduct>
        <drugdosagetext>600 MG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE (NGX)</medicinalproduct>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENTAMICIN (NGX)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131304-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2010GB13024</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHOROIDAL COLOBOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRIS COLOBOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NERVE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugauthorizationnumb>075049</drugauthorizationnumb>
        <drugdosagetext>MATERNAL DOSE: 20 MG, QD</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADONE</medicinalproduct>
        <drugdosagetext>MATERNAL DOSE: 130 MG, QD</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADONE</medicinalproduct>
        <drugdosagetext>MATERNAL DOSE: 100 MG, QD</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAZODONE</medicinalproduct>
        <drugdosagetext>MATERNAL DOSE: 50 MG, QD</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CERAZETTE</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091207</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131305-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2010CZ13234</companynumb>
    <primarysource>
      <reportercountry>CZECH REPUBLIC</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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGEAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBARACHNOID HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE (NGX)</medicinalproduct>
        <drugdosagetext>20 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENTAL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE (NGX)</medicinalproduct>
        <drugdosagetext>60 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>070733</drugauthorizationnumb>
        <drugdosagetext>800 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>070733</drugauthorizationnumb>
        <drugdosagetext>400 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>0.5 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANALGESICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131306-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7029626</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>OPTIC NEURITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131307-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2010DE13361</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOCOMP (NGX)</medicinalproduct>
        <drugauthorizationnumb>073586</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131308-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2010FI13184</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENURESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LINATIL (NGX)</medicinalproduct>
        <drugauthorizationnumb>075048</drugauthorizationnumb>
        <drugdosagetext>UP TO 10 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOVASCULAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060726</drugenddate>
        <drugtreatmentduration>70</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRESIS</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN ^LEO^</medicinalproduct>
        <drugdosagetext>0.8 ML, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131309-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2010GB13187</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>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugauthorizationnumb>077766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDICOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131311-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL188216</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS FLOATERS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P059022</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060721</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1016930</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>12.5 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131312-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028319</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>DIABETIC FOOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131313-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2010SE55644</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>GASTRIC BYPASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALABSORPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131314-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2010SE03878</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080501</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131315-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2010SE55147</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>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101029</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131316-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-07115BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.25</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMPULSIVE SHOPPING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSEXUALITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPULSE-CONTROL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE-COMPULSIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOLOGICAL GAMBLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030929</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131317-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-BAXTER-2010BH028860</companynumb>
    <primarysource>
      <reportercountry>INDIA</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>1010022</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>1009085</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>1002033</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101125</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131320-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010155706</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>21.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSFUSION REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugindication>BONE SARCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugauthorizationnumb>011856</drugauthorizationnumb>
        <drugindication>BONE SARCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugindication>BONE SARCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>L-MTP-PE</medicinalproduct>
        <drugindication>BONE SARCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN ^AVENTIS PHARMA^</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101014</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMNICEF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100824</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUTAMINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCALTROL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100624</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUMS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM/SODIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131321-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2010160560</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>25 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100831</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100907</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100913</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JODID</medicinalproduct>
        <drugdosagetext>200 MCG, 1X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPIPRAMOL</medicinalproduct>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100906</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTOCORT EC</medicinalproduct>
        <drugdosagetext>1.5 MG, 1X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100912</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131322-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028367</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 FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131325-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-CEPHALON-2010006158</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugauthorizationnumb>021947</drugauthorizationnumb>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugauthorizationnumb>021947</drugauthorizationnumb>
        <drugadministrationroute>002</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugindication>CANCER PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131326-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028377</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101117</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131327-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-TEVA-256514ISR</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>074656</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>MALIGNANT NEOPLASM OF RENAL PELVIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLEOMYCIN SULFATE</medicinalproduct>
        <drugindication>MALIGNANT NEOPLASM OF RENAL PELVIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131329-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-731692</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</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>7131330-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-448803</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADJUSTMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POUCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTOCOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPOUSAL ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIOLENCE-RELATED SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131331-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-647871</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APHTHOUS STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SPRAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040407</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAZ CLEANSER</medicinalproduct>
        <drugindication>ACNE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131332-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-GENZYME-CAMP-1000573</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEMTUZUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>12 MG, QDX5</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090206</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEMTUZUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>12 MG, QDX3</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100203</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1.0 G, QDX3</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090204</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1.0 G, QDX3</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100203</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131333-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-708641</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugbatchnumb>B1129</drugbatchnumb>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131334-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-722254</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131335-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-730467</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugdosagetext>DOSAGE IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080826</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080922</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090310</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090407</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090703</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090731</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100302</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100506</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugdosagetext>DISCONTINUED.</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100730</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugdosagetext>DIVIDED INTO 2 DOSES</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugdosagetext>DIVIDED INTO 2 DOSES.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080731</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIMATIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090310</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090731</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090731</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTECADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100730</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONALON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE PALMITATE</medicinalproduct>
        <drugdosagetext>DRUG REPORTED: LIMETHASON</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131336-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-736727</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>DAY 1 EVERY 15 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100805</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>DAY 1 EVERY 15 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100826</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100805</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>DOSE: 6 AUC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100805</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
        <drugdosagetext>THERAPY WAS ONGOING</drugdosagetext>
        <drugindication>NAUSEA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILK OF MAGNESIA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100924</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULCOLAX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100924</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM PHOSPHATES</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100924</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100924</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131337-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ROCHE-737664</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100924</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100924</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131340-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-743676</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MYELOFIBROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131342-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080513</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-745221</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131343-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NAPPMUNDI-USA-2010-0054312</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022272</drugauthorizationnumb>
        <drugdosagetext>80 MG, SEE TEXT</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131345-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ELI_LILLY_AND_COMPANY-AU201011004284</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131346-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-09P-087-0584250-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090724</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBAMIPIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIFDOBACTERIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROTIZOLAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESILATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131347-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-10P-087-0671451-00</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>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE SUBCUTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100727</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN POTASSIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100805</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN POTASSIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN POTASSIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN POTASSIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN POTASSIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN POTASSIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN POTASSIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</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>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>ADVERSE EVENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN HYDRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100816</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131348-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0665193-00</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>MYOCARDIAL INFARCTION</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>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>FLUID RETENTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131350-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2010SE55657</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>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131351-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2010SE55655</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>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAZADYNE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100704</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APIXABAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100605</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APIXABAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100605</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100704</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100704</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100718</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANEXA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100830</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131352-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA-2010-0056068</companynumb>
    <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>RYZOLT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021745</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131353-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-12802BP</companynumb>
    <primarysource>
      <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>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021698</drugauthorizationnumb>
        <drugdosagetext>150 MG</drugdosagetext>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131354-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TYCO HEALTHCARE/MALLINCKRODT-T201000331</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>RETCHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLIN</medicinalproduct>
        <drugauthorizationnumb>040300</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131355-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100609</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TYCO HEALTHCARE/MALLINCKRODT-T201000856</companynumb>
    <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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STUPOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLIN</medicinalproduct>
        <drugbatchnumb>1124M66850</drugbatchnumb>
        <drugauthorizationnumb>040300</drugauthorizationnumb>
        <drugdosagetext>20 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AUTONOMIC NEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100310</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLIN</medicinalproduct>
        <drugauthorizationnumb>040300</drugauthorizationnumb>
        <drugdosagetext>1/2 TABLET, TID</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>1 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131356-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100623</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TYCO HEALTHCARE/MALLINCKRODT-T201001501</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLIN</medicinalproduct>
        <drugauthorizationnumb>040300</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131357-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100802</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TYCO HEALTHCARE/MALLINCKRODT-T201001734</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLIN</medicinalproduct>
        <drugauthorizationnumb>040300</drugauthorizationnumb>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131358-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100204</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TYCO HEALTHCARE/MALLINCKRODT-T201000600</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.039</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLIN</medicinalproduct>
        <drugbatchnumb>1121N71970</drugbatchnumb>
        <drugauthorizationnumb>040300</drugauthorizationnumb>
        <drugdosagetext>1 OR 2 4X PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugdosagetext>10 OR 20 MG - 1/DAY</drugdosagetext>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTYNIN</medicinalproduct>
        <drugdosagetext>2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVETIRACETAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VIT</medicinalproduct>
        <drugdosagetext>1/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN A</medicinalproduct>
        <drugdosagetext>1/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131359-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100212</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TYCO HEALTHCARE/MALLINCKRODT-T201000646</companynumb>
    <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>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLIN</medicinalproduct>
        <drugauthorizationnumb>040300</drugauthorizationnumb>
        <drugdosagetext>1/4 TAB PRN</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugdosagetext>40 UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRO</medicinalproduct>
        <drugdosagetext>1 MG, QID PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>40 MG, Q8 HOURS PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL                           /00174602/</medicinalproduct>
        <drugdosagetext>1 Q 3 DAYS</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NUCYNTA</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
        <drugindication>BREAKTHROUGH PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131360-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TYCO HEALTHCARE/MALLINCKRODT-T200902314</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>
      <patientweight>45.351</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIGHT IN SCHOOL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLIN</medicinalproduct>
        <drugauthorizationnumb>040300</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAYTRANA</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAYTRANA</medicinalproduct>
        <drugdosagetext>15 MG, QD</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAYTRANA</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAYTRANA</medicinalproduct>
        <drugbatchnumb>40848</drugbatchnumb>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTUNIV</medicinalproduct>
        <drugbatchnumb>A50866A</drugbatchnumb>
        <drugdosagetext>1 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091109</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTUNIV</medicinalproduct>
        <drugdosagetext>2 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091117</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131361-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091230</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TYCO HEALTHCARE/MALLINCKRODT-T200902387</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLIN</medicinalproduct>
        <drugauthorizationnumb>040300</drugauthorizationnumb>
        <drugdosagetext>20 MG, BID</drugdosagetext>
        <drugindication>NARCOLEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
        <drugdosagetext>30 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugindication>OEDEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDREA</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131362-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TYCO HEALTHCARE/MALLINCKRODT-T201002126</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLIN</medicinalproduct>
        <drugbatchnumb>1124P75297</drugbatchnumb>
        <drugauthorizationnumb>040300</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131363-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-CELGENEUS-028-21880-10112722</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131364-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010005135</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>AORTIC ANEURYSM REPAIR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER 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>20030402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101026</drugenddate>
        <drugtreatmentduration>2765</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131366-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101121</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101108401</companynumb>
    <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>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHILDREN'S TYLENOL SUSPENSION</medicinalproduct>
        <drugbatchnumb>143E</drugbatchnumb>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHILDREN'S TYLENOL SUSPENSION</medicinalproduct>
        <drugbatchnumb>143E</drugbatchnumb>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131367-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7028502</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>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131370-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PURDUE-USA-2010-0055914</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021745</drugauthorizationnumb>
        <drugdosagetext>UNK MG, SEE TEXT</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
        <drugtreatmentduration>61</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021745</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090601</drugenddate>
        <drugtreatmentduration>61</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131371-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-BAXTER-2010BH029158</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BURKITT'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BURKITT'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BURKITT'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BURKITT'S LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131372-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2010158235</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>GASTRIC INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101123</drugenddate>
        <drugtreatmentduration>39</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131373-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2010158178</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE COLOUR ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHEST PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101120</drugenddate>
        <drugtreatmentduration>143</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131374-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2010158523</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</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>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131375-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2010154127</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZULFIDINE</medicinalproduct>
        <drugauthorizationnumb>007073</drugauthorizationnumb>
        <drugdosagetext>1 DF, 2X/DAY</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZULFIDINE</medicinalproduct>
        <drugauthorizationnumb>007073</drugauthorizationnumb>
        <drugdosagetext>2 DF, 2X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131376-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2010119561</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100824</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugdosagetext>15 MG, SINGLE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100907</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
        <drugdosagetext>5 MG, SINGLE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL</medicinalproduct>
        <drugdosagetext>5 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETIMIBE</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugdosagetext>20 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>50 UG, SINGLE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>5 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL</medicinalproduct>
        <drugdosagetext>100 UG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG, 1X/DAY AT NIGHT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIOTROPIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131377-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101121</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010115032</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>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING DRUNK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING GUILTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRUSTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHIATRIC SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOBACCO USER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </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>20100904</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>1 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>1 MG, 2X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugdosagetext>500 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugindication>MENTAL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>15 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENTAL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>1 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugindication>MENTAL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131379-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-257171USA</companynumb>
    <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>ALBUTEROL SULFATE AUTOHALER</medicinalproduct>
        <drugauthorizationnumb>021457</drugauthorizationnumb>
        <drugdosagetext>PRN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131381-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH027295</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>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101112</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131382-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-CEPHALON-2010002234</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>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RALES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TREANDA</medicinalproduct>
        <drugauthorizationnumb>022249</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090204</drugenddate>
        <drugtreatmentduration>68</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TREANDA</medicinalproduct>
        <drugauthorizationnumb>022249</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090304</drugenddate>
        <drugtreatmentduration>68</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TREANDA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090402</drugenddate>
        <drugtreatmentduration>68</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131383-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2010US18276</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>81.633</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASCRIPTIN BUFFERED REG STRENGTH TABLETS (NCH)</medicinalproduct>
        <drugdosagetext>325 MG, QOD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19630101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131384-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2010US18017</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVACID 24 HR</medicinalproduct>
        <drugbatchnumb>23888601</drugbatchnumb>
        <drugauthorizationnumb>022327</drugauthorizationnumb>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ADDISON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID THERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131385-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2010US18271</companynumb>
    <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>ASCRIPTIN BUFFERED CAPS UNKNOWN FORMULA (NCH)</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131386-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2010US17642</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>90.703</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAS-X EXTRA STRENGTH (NCH)</medicinalproduct>
        <drugbatchnumb>101093</drugbatchnumb>
        <drugdosagetext>125 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FLATULENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101104</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131387-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201009004717</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50.794</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER TRANSITIONAL CELL CARCINOMA STAGE I</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTOCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTOCELE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A723778C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D</medicinalproduct>
        <drugdosagetext>120 IU, 2/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugdosagetext>UNK, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugdosagetext>1200 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GELATIN</medicinalproduct>
        <drugdosagetext>UNK, 3/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>0.05 MG, EACH EVENING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugdosagetext>0.5 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>1200 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>650 MG, 2/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>UNK, 2/W</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STOOL SOFTENER</medicinalproduct>
        <drugdosagetext>UNK, 2/D</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131388-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR201008004200</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100926</drugenddate>
        <drugtreatmentduration>259</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131389-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201009007023</companynumb>
    <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 OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC BYPASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGAMENT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGAMENTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A728051C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131390-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR201011005488</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100923</drugenddate>
        <drugtreatmentduration>305</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131391-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR201011005411</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>96</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CLAVICLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100518</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131392-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR201011005092</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOPHLEBITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100219</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131393-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201007005797</companynumb>
    <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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A709637C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A719441C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A723778C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101016</drugenddate>
        <drugtreatmentduration>100</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COENZYME Q10</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131394-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200912001840</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131395-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR201006007130</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOPHLEBITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100323</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131396-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201006004380</companynumb>
    <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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB ASYMMETRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100605</drugenddate>
        <drugtreatmentduration>485</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A713107C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100710</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE + CHONDROITIN</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131398-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010156473</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>44.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PORPHYRIA NON-ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>004782</drugauthorizationnumb>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131399-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2010160142</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>ACUTE CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugindication>RENAL CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131400-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010159304</companynumb>
    <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>REVATIO</medicinalproduct>
        <drugauthorizationnumb>021845</drugauthorizationnumb>
        <drugdosagetext>20 MG, 3X/DAY</drugdosagetext>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131401-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010158706</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131402-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010147602</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>POLYMYOSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131403-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PFIZER INC-2010155797</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131404-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-CEPHALON-2010005388</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TREANDA</medicinalproduct>
        <drugauthorizationnumb>022249</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100921</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOXONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYL SALICYLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXEPIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEXANE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131406-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-MEDIMMUNE-MEDI-0011803</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSE OF OPPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101015</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131407-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-JPNCT2010005593</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD BETA-D-GLUCAN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANITUMUMAB</medicinalproduct>
        <drugdosagetext>6 MG/KG, Q2WK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101025</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131408-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006206</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>NEULASTA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131409-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MEDIMMUNE-MEDI-0011835</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>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131410-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-GILEAD-E2B_00000958</companynumb>
    <primarysource>
      <reportercountry>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>ALANINE AMINOTRANSFERASE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PHOSPHORUS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADEFOVIR DIPIVOXIL KIT</medicinalproduct>
        <drugauthorizationnumb>021449</drugauthorizationnumb>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPY</medicinalproduct>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131411-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-TEVA-255590ISR</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugauthorizationnumb>020622</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131412-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2010-35917</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070208</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131413-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2010-41451</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>EP069P0101</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
        <drugtreatmentduration>779</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CHANNEL BLOCKERS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131414-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2010-39526</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSCALCULIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLOGICAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugbatchnumb>EP068P0103 + DP02P0102</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100323</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>31.25 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CHANNEL BLOCKERS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131415-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2010-40902</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugbatchnumb>EP670101</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTAVIS</medicinalproduct>
        <drugbatchnumb>01510H</drugbatchnumb>
        <drugdosagetext>10 ?G, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101115</drugenddate>
        <drugtreatmentduration>47</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131416-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2010-41476</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>AORTIC STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugbatchnumb>DP026P0102</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040219</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APRESOLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLO-MAG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131417-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2010-36647</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>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090327</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131418-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13299BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONTROL OF LEGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>001452</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101125</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131419-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13300BP</companynumb>
    <primarysource>
      <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>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131420-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10112447</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>IMMUNE SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131421-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2010138228</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</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>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRENTAL ^ALBERT-ROUSSEL^</medicinalproduct>
        <drugdosagetext>400 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugdosagetext>500 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOFAGE</medicinalproduct>
        <drugdosagetext>500 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131422-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2010-40692</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEART TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugbatchnumb>EP069P0101</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100922</drugenddate>
        <drugtreatmentduration>173</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131423-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2010-40657</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>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugbatchnumb>EP071P0103</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101006</drugenddate>
        <drugtreatmentduration>41</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131424-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2010-41045</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEART TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100924</drugenddate>
        <drugtreatmentduration>470</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CHANNEL BLOCKERS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131425-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-CEPHALON-2010005606</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TREANDA</medicinalproduct>
        <drugauthorizationnumb>022249</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
        <drugtreatmentduration>168</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
        <drugtreatmentduration>169</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100720</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACICLODAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100531</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131428-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-CELGENEUS-087-21880-10112085</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>33</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100918</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIYA BM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101010</drugenddate>
        <drugtreatmentduration>231</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOUGHMAC E</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101010</drugenddate>
        <drugtreatmentduration>242</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HAEMOCHROMATOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100912</drugenddate>
        <drugtreatmentduration>57</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAUZELIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100919</drugenddate>
        <drugtreatmentduration>52</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELL TRANSFUSION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131429-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH004283</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD MAGNESIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID OVERLOAD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080324</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080329</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080326</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080403</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOBUTAMINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NALOXONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETASONE DIPROPIONATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</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>TIOTROPIUM BROMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCINEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</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>2</drugcharacterization>
        <medicinalproduct>PIPERACILLIN W/TAZOBACTAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOSYN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131430-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH006505</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>74</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLLAPSE OF LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPARIN-INDUCED THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPEROSMOLAR STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVOLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MECHANICAL VENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR SKILLS IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS IN DEVICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HAEMODIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZEMPLAR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE HCL 25MG TAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULCOLAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEPHRO-VITE RX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT                                 /USA/</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOSYN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131432-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10112210</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 HUMAN CHORIONIC GONADOTROPIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131434-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US79651</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugdosagetext>2.5 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRAIN NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100611</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131435-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US78716</companynumb>
    <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 MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100129</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131436-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010DE81243</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CGS 20267 T30748+</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugdosagetext>2.5 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100730</drugenddate>
        <drugtreatmentduration>192</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100730</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131437-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US78823</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARBOHYDRATE ANTIGEN 125 INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131438-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010RU10172</companynumb>
    <primarysource>
      <reportercountry>RUSSIAN FEDERATION</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOREDUCTIVE SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMN107 AMN+CAP</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100517</drugenddate>
        <drugtreatmentduration>120</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131439-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10110771</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>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100301</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090801</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131440-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010GB17424</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO CENTRAL NERVOUS SYSTEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTATIC MALIGNANT MELANOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERFORMANCE STATUS DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMN107 AMN+CAP</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100922</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131441-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US81171</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131442-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010GB08837</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>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHOSPHATAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100523</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100609</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARA-C</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100523</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAUNORUBICIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACICLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLIZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOZINAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHOSPHATE-SANDOZ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMILORIDE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131443-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>LB-ABBOTT-10P-093-0683274-00</companynumb>
    <primarysource>
      <reportercountry>LEBANON</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LABILE BLOOD PRESSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOGEN RESISTANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYNT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORETIC 100</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELTROXIN</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>OROCAL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTECINA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131444-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-10P-167-0683728-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100715</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131445-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-10P-028-0685341-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.94</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>15MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVAN</medicinalproduct>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugindication>SLEEP DISORDER THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131446-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10113085</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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101103</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131449-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-PFIZER INC-2010156259</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</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>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENEFIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HAEMOPHILIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101122</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131450-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2010158944</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE HYCLATE</medicinalproduct>
        <drugauthorizationnumb>050007</drugauthorizationnumb>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOWER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101114</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONIC ACID</medicinalproduct>
        <drugdosagetext>70 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>250 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOWER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL</medicinalproduct>
        <drugdosagetext>5 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICHEW-D3</medicinalproduct>
        <drugdosagetext>1 DF, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>15 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131451-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010138900</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>2 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101016</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131452-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2010158146</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugauthorizationnumb>012151</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORIATANE</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IXEL</medicinalproduct>
        <drugdosagetext>1 DF, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORVASAL</medicinalproduct>
        <drugdosagetext>2 MG, 3X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40 MG A DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugdosagetext>2 A DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARDEGIC</medicinalproduct>
        <drugdosagetext>160 MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARDYFERON</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugdosagetext>400 UG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131453-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US51234</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>
      <reaction>
        <reactionmeddrapt>POOR PERSONAL HYGIENE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131455-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-RA-00302RA</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</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>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131456-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-07116BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64.86</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE-COMPULSIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOLOGICAL GAMBLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131457-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010158848</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131458-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2010157010</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugdosagetext>0.25 MG, 1X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131459-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010022390</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COLESTID</medicinalproduct>
        <drugauthorizationnumb>020222</drugauthorizationnumb>
        <drugdosagetext>5 G, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN</medicinalproduct>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>25 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE ABNORMAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131460-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-PFIZER INC-2010158326</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131461-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010126336</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>25</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN-LOSING GASTROENTEROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugauthorizationnumb>020280</drugauthorizationnumb>
        <drugdosagetext>0.6 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090809</drugenddate>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugauthorizationnumb>020280</drugauthorizationnumb>
        <drugdosagetext>0.8 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DWARFISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100831</drugenddate>
        <drugtreatmentduration>387</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131462-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-PFIZER INC-2010158682</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>200 MG, 1X/DAY</drugdosagetext>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS HCT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131463-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010160356</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>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOSYN</medicinalproduct>
        <drugauthorizationnumb>050684</drugauthorizationnumb>
        <drugdosagetext>4.5 G, 2X/DAY</drugdosagetext>
        <drugindication>DIFFUSE PANBRONCHIOLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100912</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOSYN</medicinalproduct>
        <drugauthorizationnumb>050684</drugauthorizationnumb>
        <drugdosagetext>4.5 G, 4X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100913</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugdosagetext>200 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIFFUSE PANBRONCHIOLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
        <drugdosagetext>1500 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIFFUSE PANBRONCHIOLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugdosagetext>4 DF, 1X/DAY</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100913</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131464-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2010111481</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugdosagetext>400 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BRONCHOPULMONARY ASPERGILLOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100809</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAZOCILLINE</medicinalproduct>
        <drugdosagetext>4 G, 3X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSEUDOMONAL BACTERAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100809</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INIPOMP</medicinalproduct>
        <drugauthorizationnumb>020988</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100710</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>500 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSEUDOMONAL BACTERAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100808</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIKACIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100710</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASTAREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TANAKAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131465-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010157098</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>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>25 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>UNK MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA PERIPHERAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131466-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2010157726</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>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100329</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ISCHAEMIC HEART DISEASE PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE</medicinalproduct>
        <drugdosagetext>50 UG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131467-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-US-WYE-H16364810</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>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD BANGING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSTILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPULSIVE BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNAMBULISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>37.5 MG, 1X/DAY</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>37.5 MG, 2X/DAY</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>50 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>5 MG, 1X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>5 MG, 2X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>12.5 MG, 1X/DAY</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE</medicinalproduct>
        <drugdosagetext>50 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
        <drugdosagetext>100 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugdosagetext>1 MG PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugdosagetext>PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131468-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101128</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-PFIZER INC-2010158712</companynumb>
    <primarysource>
      <reportercountry>CHINA</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>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugauthorizationnumb>021130</drugauthorizationnumb>
        <drugdosagetext>600 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101114</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131469-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-TEVA-257131ISR</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>HYPERPYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugauthorizationnumb>040333</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM LEVOFOLINATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE SODIUM PHOSPHATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUTATHIONE SODIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHEMOTHERAPY NEUROTOXICITY ATTENUATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100928</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131470-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-TEVA-256853ISR</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugauthorizationnumb>076846</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE W/LOSARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEBIVOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040413</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081104</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131471-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-TEVA-256789ISR</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>HAEMORRHAGIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>022160</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100617</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100812</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100617</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100617</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131472-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-TEVA-256803ISR</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>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOTRIMAZOLE</medicinalproduct>
        <drugauthorizationnumb>073306</drugauthorizationnumb>
        <drugindication>CANDIDIASIS</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugindication>CANDIDIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CILEST</medicinalproduct>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131473-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-TEVA-257127ISR</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugbatchnumb>10E07KA,10H11KA</drugbatchnumb>
        <drugauthorizationnumb>022160</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugbatchnumb>10E07KA,10H11KA</drugbatchnumb>
        <drugauthorizationnumb>022160</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101125</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131474-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-TEVA-256509ISR</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>074656</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101022</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131476-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GENENTECH-295946</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANIBIZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>0.05 ML, UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090728</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFCAPENE PIVOXIL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090729</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090729</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VISUDYNE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADONA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090831</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131477-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-GENENTECH-309331</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OPPORTUNISTIC INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL HERPES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>700 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>700 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1300 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>87 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>87 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>G-CSF</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>6 MG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIPERACILLIN AND TAZOBACTAM</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>45 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FEBRILE NEUTROPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100927</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>240 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FEBRILE NEUTROPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100927</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALACICLOVIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES VIRUS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101026</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131478-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GENENTECH-303022</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREATH SOUNDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>S0055B</drugbatchnumb>
        <drugdosagetext>225 MG, Q2W</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050718</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131479-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI040837</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>LUNG CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131480-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-GENENTECH-296694</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>BONE MARROW TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>675 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>1350 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugdosagetext>90 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE</medicinalproduct>
        <drugdosagetext>25 A?G, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131481-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10072538</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101027</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090313</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLOW FE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060825</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NUTRITIONAL SUPPLEMENTS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RYTHMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM 600 + D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060825</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE CHONDROITIN</medicinalproduct>
        <drugdosagetext>500-400</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060625</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>1000 UNIT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100803</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131482-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CEPHALON-2010006083</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRREGULAR SLEEP PHASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR ICTERUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>YELLOW SKIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVIGIL</medicinalproduct>
        <drugauthorizationnumb>021875</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FATIGUE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131483-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2010157905</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>
      <patientweight>95</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE BITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOSTINEX</medicinalproduct>
        <drugauthorizationnumb>020664</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PROLACTIN ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101114</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugindication>POOR PERIPHERAL CIRCULATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131484-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2010125833</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <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>20100610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100927</drugenddate>
        <drugtreatmentduration>110</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131485-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010153631</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>MENSTRUAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>084349</drugauthorizationnumb>
        <drugdosagetext>100 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>250 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131486-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2010155755</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</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>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131487-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2010152882</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANKYLOSING SPONDYLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100325</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>150 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100414</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>DOXACOR</medicinalproduct>
        <drugdosagetext>2 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugdosagetext>16 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>METAMIZOLE SODIUM</medicinalproduct>
        <drugdosagetext>100 DROPS DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100407</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>METAMIZOLE SODIUM</medicinalproduct>
        <drugdosagetext>110 DROPS DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100412</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>IMBUN</medicinalproduct>
        <drugdosagetext>600 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIPAMPERONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100405</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100611</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRAGEST</medicinalproduct>
        <drugdosagetext>UNK, EVERY 2 WEEKS</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugdosagetext>20 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugdosagetext>30 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100414</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131488-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010120604</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>100.68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK LEFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100920</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100920</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED *NO SUBJECT DRUG</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100920</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100920</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100920</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100920</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100920</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLOR-TRIMETON</medicinalproduct>
        <drugdosagetext>4 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100507</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100526</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>20 MEQ, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100507</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANEXA</medicinalproduct>
        <drugdosagetext>1000 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>0.15 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROID DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
        <drugdosagetext>5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>81 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131489-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010145204</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NICOTINE DEPENDENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100813</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </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>20100814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100817</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>1 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100818</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131490-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PFIZER INC-2010135218</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.864</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>STANDARD</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100926</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131491-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2008069639</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>66</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUNITINIB MALATE</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080815</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOSITOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASLON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080804</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080726</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTAZOCINE LACTATE</medicinalproduct>
        <drugdosagetext>15 MG</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080813</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131492-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2010160655</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NEURITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAPILLOEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugauthorizationnumb>018972</drugauthorizationnumb>
        <drugdosagetext>200 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100828</drugenddate>
        <drugtreatmentduration>127</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131493-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15341829</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>
      <patientweight>71</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDA TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugbatchnumb>09C00510A</drugbatchnumb>
        <drugdosagetext>NO.OF INF:4, RECENT INF ON 21SEP2010. 64.286MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100921</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>29.5238(UNITS NOT SPECIFIED); RECENT INF ON 21SEP2010 (2ND INF).</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100921</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugdosagetext>INTERRUPTED ON 21SEP10 NO.OF INF:2, RECENT INF ON 21SEP2010. 42.381MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100921</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREGABALIN</medicinalproduct>
        <drugdosagetext>450MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN</medicinalproduct>
        <drugdosagetext>WITH FOOD AT DINNER.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOSPORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOTRIMAZOLE</medicinalproduct>
        <drugdosagetext>CREAM</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE AND ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN LOCK-FLUSH</medicinalproduct>
        <drugdosagetext>1 DF = 500 UNITS/5 ML SOLN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>1 DF = 20MG/ML</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
        <drugdosagetext>8 X DAY, PRN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYMORPHONE</medicinalproduct>
        <drugdosagetext>Q12H</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100826</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131494-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-CELGENEUS-056-21880-10110800</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100323</drugenddate>
        <drugtreatmentduration>249</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
        <drugtreatmentduration>249</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugdosagetext>1/4 AND 1/2</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>0.25</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IXPRIM</medicinalproduct>
        <drugdosagetext>0.25</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORECORMON ^ROCHE^</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIDOSE</medicinalproduct>
        <drugdosagetext>2</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIATEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFFU K</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101017</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101017</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCIDION</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101017</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131495-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-AMGEN-QUU441981</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>UNK UNK, Q2WK</drugdosagetext>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131496-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-AMGEN-QUU436560</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG SPECIFIC ANTIBODY PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETICULIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPHYLAXIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>UNK UNK, QWK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIDEPRESSANTS</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUETIAPINE</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE MAGNESIUM</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131497-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2008BH002286</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>113</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID OVERLOAD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>107054</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080310</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>107054</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080310</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <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>NIFEDIPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</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>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</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>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HECTOROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENSIPAR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-COMPLEX, OTHER COMBINATIONS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131498-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL394862</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC BYPASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101014</drugenddate>
        <drugtreatmentduration>576</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>15 MG, QWK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN                           /00256202/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131499-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-JPNCT2010000651</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>HEPATIC CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DENOSUMAB</medicinalproduct>
        <drugdosagetext>DENOSUMAB 60MG OR PLACEBO</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICHEW D3</medicinalproduct>
        <drugdosagetext>2 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100905</drugenddate>
        <drugtreatmentduration>691</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100905</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131500-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL338577</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT MYOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1019848</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040207</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131501-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-AMGEN-KDL439997</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>780 A?G, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>BLOOD STEM CELL HARVEST</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100912</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMAC</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131502-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU428467</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROID NOS</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100707</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131503-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL442151</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEARING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UROSEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETIMIBE</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTROPROPOXYPHENE NAPSILATE W/ ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131504-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101020</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2008BH003289</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>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHEST PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CATHETERISATION CARDIAC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>117034</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>117034</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>117034</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>117034</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHEST PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN IN DEXTROSE 5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHEST PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHEST PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>065</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>MAG-OX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugadministrationroute>065</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>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090811</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPINEPHRINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCINEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAALOX                                  /USA/</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <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>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NARCAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131505-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028315</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131506-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-PFIZER INC-2010154267</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>EYE INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131507-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-PFIZER INC-2010125230</companynumb>
    <primarysource>
      <reportercountry>GREECE</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>MENSTRUATION DELAYED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSONISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugdosagetext>80 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131508-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-PFIZER INC-2009249354</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugauthorizationnumb>021267</drugauthorizationnumb>
        <drugdosagetext>400 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ASPERGILLOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080220</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugauthorizationnumb>021267</drugauthorizationnumb>
        <drugdosagetext>260 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080321</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugauthorizationnumb>021267</drugauthorizationnumb>
        <drugdosagetext>260 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080423</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUTROGIN</medicinalproduct>
        <drugdosagetext>250 UG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080322</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131509-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-PFIZER INC-2009249252</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugauthorizationnumb>021266</drugauthorizationnumb>
        <drugdosagetext>200 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASPERGILLOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080320</drugenddate>
        <drugtreatmentduration>60</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNERCID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080123</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080125</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEPTRIN</medicinalproduct>
        <drugdosagetext>400 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080126</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080125</drugenddate>
        <drugtreatmentduration>64</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080320</drugenddate>
        <drugtreatmentduration>55</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUTROGIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080123</drugenddate>
        <drugtreatmentduration>63</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODEOXYCHOLIC ACID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080126</drugenddate>
        <drugtreatmentduration>62</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080126</drugenddate>
        <drugtreatmentduration>62</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131510-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2010154130</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>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131511-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJCH-2010027048</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>ANAPHYLACTOID REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugauthorizationnumb>019835</drugauthorizationnumb>
        <drugdosagetext>TEXT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131512-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028823</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131513-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-744883</companynumb>
    <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>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131514-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101108600</companynumb>
    <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>ORAL HERPES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131515-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-JNJFOC-20101005025</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</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>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEHEPAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TROMBYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIPREX</medicinalproduct>
        <drugdosagetext>3 G</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETALPHA</medicinalproduct>
        <drugdosagetext>0.25 MICROGRAM</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131516-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-665097</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBANDRONIC ACID</medicinalproduct>
        <drugbatchnumb>RJ0364, RJ0369</drugbatchnumb>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugdosagetext>ADDITIONAL INDICATION: PAGET'S DISEASE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURAN T4</medicinalproduct>
        <drugdosagetext>FREQUENCY: 1 TABLET PER DAY,OTHER INDICATION: HASHIMOTO'S THYROIDITIS, RECEIVED UNDER FASTING.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROID DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APROVEL</medicinalproduct>
        <drugdosagetext>FREQUENCY: 1 TABLET PER DAY,TAKEN AFTER BREAKFAST</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugdosagetext>FREQUENCY: 1 TABLET PER DAY, INDICATION ^STRENGTHEN^.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE 600 + D</medicinalproduct>
        <drugdosagetext>FREQUENCY: 1 TABLET PER DAY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAFLON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VARICOSE VEIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONDROFLEX</medicinalproduct>
        <drugdosagetext>DOSE: 1.5 + 1.2 GRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>FREQUENCY: 3 TABLETS PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>FREQUENCY: EVENTUALLY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>FREQUENCY: 1 TABLET EVERY OTHER DAY, TAKEN ONE DOSE FORM.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131517-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-744864</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>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugdosagetext>DOSAGE: UNCERTAIN</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131518-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-BAXTER-2010BH028991</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>H1N1 INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG CONSOLIDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BONE SARCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>METASTASES TO LUNG</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BONE SARCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>METASTASES TO LUNG</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BONE SARCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>METASTASES TO LUNG</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BONE SARCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>METASTASES TO LUNG</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131519-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-679419</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugbatchnumb>B0003</drugbatchnumb>
        <drugdosagetext>STARTING DOSE: 64.5 MG/KG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugbatchnumb>B0003</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugbatchnumb>B0003</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugbatchnumb>B0003</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RELAFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugdosagetext>AS NECESSARY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>TAPPER DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100325</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugdosagetext>FREQUENCY: EVERY DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugdosagetext>FREQUENCY: EVERY 6 HOURS PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugdosagetext>1 INHALATION BID</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100318</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUONEB</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091230</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUONEB</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100318</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENAZPRINE</medicinalproduct>
        <drugdosagetext>AS NECESSARY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100318</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100318</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131520-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010005982</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131521-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101121</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-BAXTER-2010BH028637</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>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131522-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-DE-02683DE</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DABIGATRAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070905</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DABIGATRAN</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBASALAATCALCIUM</medicinalproduct>
        <drugdosagetext>1 ANZ</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
        <drugdosagetext>1 ANZ</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMETANIDE</medicinalproduct>
        <drugdosagetext>1 ANZ</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEBIVOLOL HCL</medicinalproduct>
        <drugdosagetext>1 ANZ</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTAGENS</medicinalproduct>
        <drugdosagetext>2 ANZ</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080812</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugdosagetext>1 ANZ</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131523-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-FF-00796FF</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHLEBITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugauthorizationnumb>063267</drugauthorizationnumb>
        <drugdosagetext>220 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>KNEE ARTHROPLASTY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROFENID</medicinalproduct>
        <drugdosagetext>200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAHOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131524-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-DE-06523GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK LEFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCOHERENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF-MEDICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEARFULNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAZODONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugauthorizationnumb>017407</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUETIAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131525-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006404</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYMYOSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1011868</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131526-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006571</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN CHAPPED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1021305</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131527-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-PFIZER INC-2009249388</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugauthorizationnumb>021266</drugauthorizationnumb>
        <drugdosagetext>200 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASPERGILLOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080415</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080415</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFDITOREN PIVOXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080415</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLCYSTEINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080415</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131528-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-PFIZER INC-2009250478</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYDROPNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugauthorizationnumb>021267</drugauthorizationnumb>
        <drugdosagetext>UNK MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ASPERGILLOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080129</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugauthorizationnumb>021267</drugauthorizationnumb>
        <drugdosagetext>200 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080318</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUTROGIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071230</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080124</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANTIBIOTIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080130</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANTIBIOTIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071230</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080127</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080209</drugenddate>
        <drugtreatmentduration>44</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE SODIUM SUCCINATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RASH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080126</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANCIDAS</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ASPERGILLOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENIRAMINE</medicinalproduct>
        <drugdosagetext>4 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANTIALLERGIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080317</drugenddate>
        <drugtreatmentduration>58</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugdosagetext>100 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTACID THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080208</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>169.32 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080228</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZAVEDOS</medicinalproduct>
        <drugdosagetext>40.63 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080225</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUPRAX ^KLINGE^</medicinalproduct>
        <drugdosagetext>100 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OESOPHAGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080308</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNOGLOBULINS</medicinalproduct>
        <drugdosagetext>5000 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BLOOD IMMUNOGLOBULIN G</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080316</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131529-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-PFIZER INC-2009249983</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugauthorizationnumb>021266</drugauthorizationnumb>
        <drugdosagetext>200 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081023</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RULID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIBIOTIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081023</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-CONTIN CONTINUS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081023</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>2250 MG DAILY DOSAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIBIOTIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081023</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEICOPLANIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081019</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081019</drugenddate>
        <drugtreatmentduration>52</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN K TAB</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081019</drugenddate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081019</drugenddate>
        <drugtreatmentduration>46</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081019</drugenddate>
        <drugtreatmentduration>74</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081019</drugenddate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131530-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH014492</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>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC LYMPHOCYTIC LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MESENTERIC VASCULAR INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSTRUCTIVE AIRWAYS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLEEN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENIC INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>065</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>2</drugcharacterization>
        <medicinalproduct>MONOPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORMAL SALINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <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>PHENERGAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAZICEF</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NARCAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIL SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARAPLATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131531-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006550</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>ENBREL</medicinalproduct>
        <drugbatchnumb>1020932</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101108</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131532-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028635</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOODY PERITONEAL EFFLUENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DRUG USED IN DIABETES</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131533-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GENENTECH-310052</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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 HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131534-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GENENTECH-297760</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>150 MG, 1/MONTH</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090807</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>150 MG, 1/MONTH</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090908</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALVESCO</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLELOCK</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULTANOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091214</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091219</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCOMITANT DRUG</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090914</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131535-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GENENTECH-309924</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>LUCENTIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131536-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20081001</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-CELGENEUS-056-21880-08100218</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131537-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-PFIZER INC-2010154951</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>HYPOMANIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>150 MG, 2X/DAY</drugdosagetext>
        <drugindication>NEURALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131538-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010117306</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>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>STARTER AND CONTINUOUS MONTH PACK</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090618</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131539-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-PFIZER INC-2010098720</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEREALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>1 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100713</drugenddate>
        <drugtreatmentduration>40</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>0.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC ATTACK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100305</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131540-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100413</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-09P-087-0597063-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090828</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080418</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FOLATE DEFICIENCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081010</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090915</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131541-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-10P-167-0665718-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC STROKE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080602</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>EVERY MONDAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>5 MG DAILY EXCEPT MONDAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE EC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISENDRONATE</medicinalproduct>
        <drugdosagetext>EVERY MONDAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADCAL D3</medicinalproduct>
        <drugdosagetext>MORNINGS EXCEPT MONDAYS. SUCK OR CHEW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPPERMINT OIL</medicinalproduct>
        <drugdosagetext>HALF AN HOUR BEFORE MEALS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>UP TO 4 TIMES A DAY WHEN NEEDED FOR PAIN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091224</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131542-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-ABBOTT-10P-082-0687514-00</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</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>ACUTE HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA HEPATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERAMMONAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugindication>MYOCLONIC EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugindication>PARTIAL SEIZURES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>SEVERAL TIMES IN STANDARD DOSES</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZODIAZEPINE RELATED DRUGS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENYLHYDANTOIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL</medicinalproduct>
        <drugdosagetext>LOADING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131543-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-10P-087-0685252-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020478</drugauthorizationnumb>
        <drugdosagetext>INDUCTION: 1%, MAINTENANCE: 1.2-1%</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>SEDATIVE THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100329</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTIVA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1749.21MCG DAILY/ 0.2-0.6 MCG/MG/MIN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100330</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTIVA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>0.1 MICROGRAM/KILOGRAM/MINUTE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROHYPNOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100329</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LINTON</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100329</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100329</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TASMOLIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100329</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GENERAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCURONIUM BROMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPOTONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCURONIUM BROMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SHOCK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTONE</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROPIVACAINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>2 MILLILITER/HOUR</drugdosagetext>
        <drugadministrationroute>008</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS</medicinalproduct>
        <drugindication>OPERATIVE HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRESH FROZEN PLASMA</medicinalproduct>
        <drugindication>OPERATIVE HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>20MG DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>1-3-3.5/MCG/KG/MIN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131544-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-10P-167-0677538-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>115</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD ALLERGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131545-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-10P-028-0685723-00</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>LUPRON DEPOT</medicinalproduct>
        <drugbatchnumb>833392E21</drugbatchnumb>
        <drugauthorizationnumb>020517</drugauthorizationnumb>
        <drugdosagetext>30 MG - 4 MONTH DEPOT</drugdosagetext>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100724</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
        <drugdosagetext>50 MG QD</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131546-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-10P-062-0687214-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101025</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131547-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0663819-00</companynumb>
    <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>ADENOMYOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADHESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDICECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED INTEREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOMETRIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRUSTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HORMONE LEVEL ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROTIC FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST RUPTURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST-TRAUMATIC STRESS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHIATRIC SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALMONELLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING PROJECTILE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPRON DEPOT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020011</drugauthorizationnumb>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>ENDOMETRIOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19930101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIRTH CONTROL PILLS</medicinalproduct>
        <drugindication>ENDOMETRIOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19820101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIRTH CONTROL PILLS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIRTH CONTROL PILLS</medicinalproduct>
        <drugdosagetext>INCREASED DOSE EVERY 2 MONTHS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugindication>ENDOMETRIOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL NATURAL ESTROGEN SUPPLEMENT LOW DOSE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131548-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-10P-062-0678522-00</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>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESALAMINE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131549-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101121</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0683831-00</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131550-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0687389-00</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>BLINDNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131551-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-10P-056-0667890-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100315</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORIATANE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131552-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0687614-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARBUNCLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SJOGREN'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131553-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-10P-087-0681495-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</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>20100910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECOBALAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE HYDRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100709</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELBINAC</medicinalproduct>
        <drugdosagetext>1 TAPE/D</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLURBIPROFEN</medicinalproduct>
        <drugdosagetext>1 TAPE/D</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
        <drugdosagetext>1 TAPE/D</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101013</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131554-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-10P-020-0687747-00</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBULA FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018723</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131555-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-10P-062-0668813-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>WEEK 0, ONCE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>WEEK 2, ONCE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MTX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYTEMIC STEROIDS</medicinalproduct>
        <drugindication>STEROID THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRIN/6-MP 200MG</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131556-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PH-BAXTER-2010BH028409</companynumb>
    <primarysource>
      <reportercountry>PHILIPPINES</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>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONEAL DIALYSIS COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>10H045</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>09U071</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>10K024</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>10K018</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100604</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131557-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20081001</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-CELGENEUS-056-21880-08100233</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>DERMATITIS BULLOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070222</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131558-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010118918</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>148</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE SUBCUTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugauthorizationnumb>012151</drugauthorizationnumb>
        <drugdosagetext>25 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100917</drugenddate>
        <drugtreatmentduration>45</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugdosagetext>1 DF, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100917</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRORENAL</medicinalproduct>
        <drugdosagetext>1 DF, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPINAL COLUMN STENOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100917</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAINTATE</medicinalproduct>
        <drugdosagetext>5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100531</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131559-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010122215</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5 MILLIGRAMS TWICE DAILY, THEN ONE MILLIGRAM TWICE DAILY</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081009</drugenddate>
        <drugtreatmentduration>72</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MUSCLE SPASMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OFLOXACIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>EAR INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUONEB</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANALGESIC THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131560-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010117491</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>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOMICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <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>20070207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070209</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>THYROID HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131561-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033664</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>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131562-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ELI_LILLY_AND_COMPANY-AU201010005002</companynumb>
    <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>GEMCITABINE HCL</medicinalproduct>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugdosagetext>1000 MG/M2 (1370MG),</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100825</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131563-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011003563</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85.261</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PERIPHERAL ARTERIAL OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRASUGREL HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugdosagetext>60 MG, OTHER</drugdosagetext>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100629</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRASUGREL HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325 MG, OTHER</drugdosagetext>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>40 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>50 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>80 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN UPPER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>10 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugdosagetext>40 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100629</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131564-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011003562</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85.261</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PERIPHERAL ARTERIAL OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRASUGREL HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugdosagetext>60 MG, OTHER</drugdosagetext>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100629</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRASUGREL HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRASUGREL HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugdosagetext>5 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>40 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>50 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>80 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN UPPER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>10 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugdosagetext>40 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100629</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131565-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011003374</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRASUGREL HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugdosagetext>60 MG ONCE</drugdosagetext>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100727</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRASUGREL HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100728</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325 MG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100727</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100728</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugdosagetext>25 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100728</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100728</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>30 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GENERALISED ANXIETY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>0.5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131566-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011006680</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>107.48</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMATOSIS INTESTINALIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>1135 MG, EVERY Q 2 WKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>91 MG,  Q 2 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>400 UG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>1000 UG, UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugdosagetext>UNK, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>20 MEQ, 2/D</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131567-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101128</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011007162</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>PRASUGREL HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100625</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131568-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011007242</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64.399</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRASUGREL HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131569-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201006001093</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-CARDIAC CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HCL</medicinalproduct>
        <drugbatchnumb>A630564A</drugbatchnumb>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugdosagetext>600 MG/M2, QOW</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>T-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OTHER PHARMA COMPANY INV DRUG</medicinalproduct>
        <drugdosagetext>15 MG/M2, QOW</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>T-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM W/VITAMIN D NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIPOTRIENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUCERIN CREME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMUCIL-2</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131570-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201003002541</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>800 MG, OTHER</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA STAGE III</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100203</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>400 MG, OTHER</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100303</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>530 MG, OTHER</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA STAGE III</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100203</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>0.5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100303</drugenddate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100129</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
        <drugdosagetext>UNK, OTHER</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100204</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXART</medicinalproduct>
        <drugdosagetext>UNK, OTHER</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100204</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN</medicinalproduct>
        <drugdosagetext>UNK, OTHER</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100204</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131571-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011007646</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRASUGREL HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugdosagetext>60 MG,ONCE</drugdosagetext>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101012</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>25 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131572-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ELI_LILLY_AND_COMPANY-AU201011006633</companynumb>
    <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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HCL</medicinalproduct>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugdosagetext>1000 MG/M2, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>125 MG/M2, WEEKLY (1/W)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALUMINUM HYDROXIDE GEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DECREASED APPETITE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLECALCIFEROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZYDAMINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CANDIDIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CANDIDIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM HYDROXIDE</medicinalproduct>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131573-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101128</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011007284</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98.866</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRASUGREL HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101026</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131574-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-ELI_LILLY_AND_COMPANY-CH201011006973</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>830 D/F, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>120 D/F, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>410 D/F, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131575-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011003559</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.236</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRASUGREL HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugdosagetext>5 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325 MG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100702</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131576-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011002614</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>500 MG/M2, OTHER (EVERY 21 DAYS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>6 D/F (AUC), OTHER EVERY 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTADINE</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100714</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100716</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131577-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006364</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>NPLATE</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101013</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131578-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13270BP</companynumb>
    <primarysource>
      <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>001699</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>25 MG</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131579-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13443YA</companynumb>
    <primarysource>
      <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>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAXTRA XL (TAMSULOSIN) ORODISPERSABLE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugdosagetext>400 UG, UID/QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131580-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-NL-00544NL</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIFROL 0.088MG</medicinalproduct>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugdosagetext>0.176 MG</drugdosagetext>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUETIAPINE</medicinalproduct>
        <drugdosagetext>300 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUMCARBONAAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUTHYROX</medicinalproduct>
        <drugdosagetext>0.5 MCG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131581-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-DE-05640DE</companynumb>
    <primarysource>
      <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>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIFROL 0,18 MG</medicinalproduct>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131582-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-PFIZER INC-2010153876</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>OCULOGYRIC CRISIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131583-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-PFIZER INC-2010153922</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131584-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-BRACCO-000059</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DUPUYTREN'S CONTRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ATROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTIHANCE</medicinalproduct>
        <drugauthorizationnumb>021357</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SCAN WITH CONTRAST</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060321</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131585-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-10P-020-0687485-00</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNODEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131586-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-ABBOTT-10P-153-0687788-00</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>APPARENT LIFE THREATENING EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>40 MG/0.8 ML</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131587-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-10P-028-0676718-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>6009037</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100929</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131588-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-10P-087-0648539-00</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>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFZON</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050739</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131589-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-ABBOTT-10P-090-0655788-00</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021906</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABC</medicinalproduct>
        <drugdosagetext>600 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZT(ZDV)</medicinalproduct>
        <drugdosagetext>600 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100518</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE (EPIVIR HBV)</medicinalproduct>
        <drugdosagetext>30 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugdosagetext>2 TABLETS, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100518</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAPSONE</medicinalproduct>
        <drugdosagetext>100MG X 1 TABLET DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIFUNGAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TS TAB</medicinalproduct>
        <drugdosagetext>1 TAB, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIFUNGAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIAGEN</medicinalproduct>
        <drugdosagetext>2 TABLETS, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGACE SUSPENSION 40MG/240ML</medicinalproduct>
        <drugdosagetext>10 ML, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DECREASED APPETITE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100514</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CJ 20% DEXTROSE WATER 0.2G/ML 1000ML</medicinalproduct>
        <drugdosagetext>1 LITER, DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MEDICAL DIET</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEBATRIM INJ</medicinalproduct>
        <drugdosagetext>4 VIAL DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANTIFUNGAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORPINE</medicinalproduct>
        <drugdosagetext>40 MG/240ML, DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100608</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131590-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ABBOTT-10P-008-0687084-00</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY BYPASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REDUCTIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020632</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131591-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-10P-167-0687391-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070816</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131592-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-10P-020-0687503-00</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
        <drugbatchnumb>890558F05</drugbatchnumb>
        <drugauthorizationnumb>012003</drugauthorizationnumb>
        <drugdosagetext>FORM STRENGTH; 2MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131593-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-10P-087-0678569-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER STAGE IV</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020708</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER STAGE IV</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070805</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOSIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOLAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BICALUTAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071118</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131594-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0686848-00</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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500MG DAILY</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </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>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </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>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131595-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010GB15967</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>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101009</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARA-C</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAUNORUBICIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACICLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORETHISTERONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SANDO K</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131596-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010US17490</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK COMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOTRACHEAL INTUBATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHOSPHATAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LYMPH NODES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONEAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>35MG/WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMPARATOR SORAFENIB</medicinalproduct>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAXAGLIPTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131597-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BE79049</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131598-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2009BH015737</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>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOSOCOMIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS IN DEVICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>87125</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>87125</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CATHETERISATION CARDIAC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>87125</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CARDIAC VENTRICULOGRAM LEFT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>87125</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANGIOGRAM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>97081</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>97081</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>97081</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>97081</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>107024</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>107024</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>107024</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>107024</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>107064</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>107064</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>107064</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>107064</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>107074</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>107074</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>107074</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>107074</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080324</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080324</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080324</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080324</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080324</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080324</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080324</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080324</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</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>ENOXAPARIN SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</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>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASK</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMEX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOBUTAMINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131599-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH000496</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>113</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTOID SYNDROME OF PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROMECHANICAL DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>087123</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDOMET</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugadministrationroute>065</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>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE CALCIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <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>PANTOPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABETALOL HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL ^ACHE^</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHERGINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTAMINE SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APRESOLINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYTOCIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131600-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010005610</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANEURYSM REPAIR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIMORBIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>0.5 A?G/KG, UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100706</drugenddate>
        <drugtreatmentduration>635</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131601-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011006135</companynumb>
    <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 AMYLASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANASAL SINUS HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>1000 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>1000 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugindication>ANEURYSM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131602-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011005555</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>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131603-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011005547</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>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131604-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201011005415</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>CUTANEOUS AMYLOIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131605-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ELI_LILLY_AND_COMPANY-BR201011006689</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG MIX 75/25</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>42 IU, EACH MORNING</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG MIX 75/25</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>38 IU, EACH EVENING</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131606-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011005525</companynumb>
    <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>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131607-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011005812</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>140.59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHLORHYDRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIC UNCONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>A735990A</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>1000 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugdosagetext>4 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHLORHYDRIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131608-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ELI_LILLY_AND_COMPANY-BR201011005879</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131609-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011005631</companynumb>
    <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>HUMALOG MIX 75/25</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131610-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200909006487</companynumb>
    <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 CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>A618310C</drugbatchnumb>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>UNK, 4/D</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>UNK, 4/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugdosagetext>20 U, EACH EVENING</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131611-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201009005301</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>HUMALOG MIX 75/25</medicinalproduct>
        <drugbatchnumb>A664903G</drugbatchnumb>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>50 U, EACH MORNING</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG MIX 75/25</medicinalproduct>
        <drugbatchnumb>A618313C</drugbatchnumb>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>50 U, EACH MORNING</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131612-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011003338</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRASUGREL HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugdosagetext>25 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>40 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100912</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugdosagetext>15000 IU, 3/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101009</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131613-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-ELI_LILLY_AND_COMPANY-KR201011006084</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 GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONOSCOPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG MIX 75/25</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131614-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GENENTECH-309065</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>GASTRIC MUCOSAL LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131615-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-GENENTECH-308899</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>3</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>PULMOZYME</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CYSTIC FIBROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061120</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131616-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-310183</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHOPROLIFERATIVE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131617-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-GENENTECH-310274</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 INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE BEFORE PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRISOMY 21</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081224</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131618-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010005630</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugbatchnumb>1013545</drugbatchnumb>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugbatchnumb>1013545</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131619-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-10P-062-0683743-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>114</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEMPLAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020819</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100818</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131620-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-08P-087-0438373-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE ILEUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPLIN SR FOR INJECTION KIT 11.25</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020708</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER STAGE III</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPLIN SR FOR INJECTION KIT 11.25</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020708</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BICALUTAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER STAGE III</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061013</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131621-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-10P-087-0685771-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>112</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020478</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>BRONCHOSPASM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INDUCTION AND MAINTENANCE OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCURONIUM BROMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMINOPHYLLINE HYDRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BRONCHOSPASM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131622-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-10P-028-0636868-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081023</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>CHOLESTYRAMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091119</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>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</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>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>ASCORBIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131623-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-10P-062-0681551-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRENANTONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020708</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATIC SPECIFIC ANTIGEN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100325</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRENANTONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020708</drugauthorizationnumb>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARCUMAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONIC ACID</medicinalproduct>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131624-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-10P-020-0675240-00</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOCTURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugbatchnumb>79379QA</drugbatchnumb>
        <drugauthorizationnumb>018723</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GARDENAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN ASPARTAME</medicinalproduct>
        <drugdosagetext>ACCORDING TO GLUCOSE ALTERATION</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131625-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-09P-087-0580611-00</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>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER STAGE IV</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020708</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020708</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TSUMURA DAIKENTYUTO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYSLEE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BICALUTAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER STAGE IV</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070719</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRAMUSTINE PHOSPHATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIETHYLSTILBESTROL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070206</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131626-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080611</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GENENTECH-310433</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131627-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-GENENTECH-306954</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1000 MG, Q15D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100428</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVALGINA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METICORTEN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TICLID</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>250 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131628-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033923</companynumb>
    <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>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100927</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131629-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006406</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1021464</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101011</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131630-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-290674</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASPIRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMALIZUMAB</medicinalproduct>
        <drugbatchnumb>744880</drugbatchnumb>
        <drugdosagetext>375 MG, Q2W</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <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>7131631-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-DE-06531DE</companynumb>
    <primarysource>
      <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>ACCIDENTAL DRUG INTAKE BY CHILD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIFROL 0,7 MG</medicinalproduct>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugdosagetext>0.7 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131632-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-10P-062-0681903-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>94</patientweight>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEMPLAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020819</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPERPARATHYROIDISM SECONDARY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENOFER</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071230</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSRENOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEKRISTOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIVACE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDIVIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOBICA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030302</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETIMIBE/SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AERIUS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEPHROTRANS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FURASAL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACANOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRESINOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTRAPID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101016</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080228</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131633-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ABBOTT-10P-144-0688239-00</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020945</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090922</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARUNAVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090922</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061214</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131634-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-08P-087-0439175-00</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>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER STAGE III</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT CC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMETEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERSYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERO-GRADUMET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEPHROGENIC ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCALTROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131635-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-ABBOTT-10P-161-0617958-00</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE FOR DATES BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL DRUGS AFFECTING FOETUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REDUCTIL 15MG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020632</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131636-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101120</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GILEAD-2010-0033357</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>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANEXA</medicinalproduct>
        <drugauthorizationnumb>021526</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMETANIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOLAZONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131637-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-10P-167-0642585-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugdosagetext>ON SATURDAYS</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>ON THURSDAYS</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070731</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISEDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>ON WEDNESDAYS</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070731</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070731</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCEOS CHEWABLE TABLETS</medicinalproduct>
        <drugdosagetext>1 MIDDAY AND 1 EVENING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>4 IN 1 D PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugdosagetext>3.35 G IN 5 ML 2 IN 1 D</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugdosagetext>INCREASING DOSE 1 IN 1 D</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE M/R</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFATER</medicinalproduct>
        <drugdosagetext>MANE</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETHAMBUTOL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>MANE</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETHAMBUTOL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIDOXINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENSURE PLUS ASSORTED FLAVOURS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENSURE PLUS CREME ASSORTED FLAVOURS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>3 IN 1 D PRN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETHAMBUTOL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>MANE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETHAMBUTOL HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131638-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006212</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1020933</drugbatchnumb>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100430</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131639-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010140261</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTATIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSONISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST HERPETIC NEURALGIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>225 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101016</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DESYREL</medicinalproduct>
        <drugdosagetext>25 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101017</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>0.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DELIRIUM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101017</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLIVAS</medicinalproduct>
        <drugdosagetext>25 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLLAKIURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101015</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLIVAS</medicinalproduct>
        <drugindication>HYPERTONIC BLADDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>50 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101009</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131640-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-PFIZER INC-2010158921</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LEARNING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>12.5 MG, 1X/DAY</drugdosagetext>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101022</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131641-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010121194</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.959</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC SPECIFIC ANTIGEN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugbatchnumb>610686</drugbatchnumb>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
        <drugdosagetext>1 DROP IN EACH EYE</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131642-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010129492</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALLODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST HERPETIC NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100909</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALONAL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE PHOSPHATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGLAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100907</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131643-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2010158962</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUPILLARY REFLEX IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101106</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEXANE</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>LYMPHOEDEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAVISCON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131644-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090515</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GENENTECH-310435</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BURKITT'S LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131645-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060412</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GENENTECH-310397</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RENAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131646-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-GENENTECH-302122</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICTURITION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY SLEEP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1000 MG, X2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091214</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091228</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIMESULIDE</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEFLAMOL</medicinalproduct>
        <drugdosagetext>6 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>50 MG, QAM</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>7131647-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GENENTECH-310216</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS B</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>375 MG/M2, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131648-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010001901</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>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080505</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>1 MG, QWK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131649-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006757</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>IMMUNOSUPPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugdosagetext>15 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131650-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090311</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GENENTECH-310394</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131651-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033612</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.701</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIASTOLIC DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT ATRIAL HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIGHT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBRISENTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TADALAFIL</medicinalproduct>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091013</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugindication>FLUID RETENTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMETANIDE</medicinalproduct>
        <drugindication>FLUID RETENTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN</medicinalproduct>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA 3 FATTY ACIDS</medicinalproduct>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOMETASONE FUROATE</medicinalproduct>
        <drugindication>NASAL CONGESTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUMS</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100726</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19820101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100726</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19820101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugindication>ELECTROLYTE SUBSTITUTION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091013</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAXSEED OIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131652-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-10P-062-0687873-00</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPRORELIN DEPOT (6M)</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020517</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100428</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROKAVIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091204</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131653-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-10P-167-0630270-00</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTHROTEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080225</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080225</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-CODAMOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080225</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080225</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131654-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-016420-10</companynumb>
    <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 EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>020733</drugauthorizationnumb>
        <drugdosagetext>DOSING INFORMATION UNKNOWN</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131655-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-016984-10</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>020733</drugauthorizationnumb>
        <drugdosagetext>DOSING INFORMATION UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131656-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-018517-10</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLON CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>020733</drugauthorizationnumb>
        <drugdosagetext>DOSAGE UNKNOWN AT THIS TIME.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131657-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-018453-10</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>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>022410</drugauthorizationnumb>
        <drugdosagetext>SUBOXONE SUBLINGUAL FILM/ DOSAGE UNKNOWN AT THIS TIME.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131658-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-018445-10</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>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>020733</drugauthorizationnumb>
        <drugdosagetext>DOSAGE UNKNOWN AT THIS TIME.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131659-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-016608-10</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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBSTANCE ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>020733</drugauthorizationnumb>
        <drugdosagetext>DOSING INFORMATION UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131660-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-016446-10</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>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>022410</drugauthorizationnumb>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>DRUG DEPENDENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugauthorizationnumb>022410</drugauthorizationnumb>
        <drugdosagetext>DOSAGE INFORMATION UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131661-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-016411-10</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>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>022410</drugauthorizationnumb>
        <drugdosagetext>UNIT DOSE AND FREQUENCY UNKNOWN.</drugdosagetext>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>DRUG DEPENDENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>022410</drugauthorizationnumb>
        <drugdosagetext>DOSING DETAILS UNKNOWN.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131662-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-018507-10</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>BREAST MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>020733</drugauthorizationnumb>
        <drugdosagetext>DOSAGE UNKNOWN AT THIS TIME.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131663-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101121</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-018634-10</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 EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE LABOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBUTEX</medicinalproduct>
        <drugauthorizationnumb>020732</drugauthorizationnumb>
        <drugdosagetext>DOSING DETAILS UNKNOWN.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131664-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-GENENTECH-302333</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>47</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATIC FEVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091113</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131665-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2010148173</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THELIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131666-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010135516</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>63</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101007</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS CITRATE</medicinalproduct>
        <drugdosagetext>100 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101004</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYDOXAL</medicinalproduct>
        <drugdosagetext>40 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOPHAGEN</medicinalproduct>
        <drugdosagetext>2 T, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC FUNCTION ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugdosagetext>1980 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100930</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131667-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-PFIZER INC-2010149168</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</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>EXFOLIATIVE RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100716</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>150 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
        <drugtreatmentduration>78</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
        <drugdosagetext>2 MG, 2X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUPENTIXOL DIHYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>2 MG + 1MG,  DAILY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131668-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010118180</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRING</medicinalproduct>
        <drugbatchnumb>KM973A</drugbatchnumb>
        <drugauthorizationnumb>020472</drugauthorizationnumb>
        <drugdosagetext>2 MG, EVERY 90 DAYS</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131669-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-PFIZER INC-2010139896</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOPOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TROPONIN T INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACICLOVIR</medicinalproduct>
        <drugdosagetext>4000 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>12.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
        <drugtreatmentduration>578</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>1 UNIT EVERY 72 HOURS</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BONE PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
        <drugtreatmentduration>578</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAUNAC</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
        <drugtreatmentduration>578</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEO-DUR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURABEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131670-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-1011DEU00066</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>86</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPROSARTAN MESYLATE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEBIVOLOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TACHYCARDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE MALEATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131671-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-1011GBR00081</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>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131672-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1011USA03393</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>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071201</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131673-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1010USA00967</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>
      <patientweight>33</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020830</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100923</drugenddate>
        <drugtreatmentduration>1362</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOCOID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ECZEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131674-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1011USA01063</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>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugauthorizationnumb>019462</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANXENE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131675-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-1006FRA00071</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MORBILLIFORM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISENTRESS</medicinalproduct>
        <drugauthorizationnumb>022145</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100514</drugenddate>
        <drugtreatmentduration>58</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISENTRESS</medicinalproduct>
        <drugauthorizationnumb>022145</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101115</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE AND ZIDOVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100514</drugenddate>
        <drugtreatmentduration>58</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101104</drugenddate>
        <drugtreatmentduration>195</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REPAGLINIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARBEPOETIN ALFA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABACAVIR SULFATE AND LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101115</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALISKIREN FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RILMENIDINE PHOSPHATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICARDIPINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101108</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131676-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1011USA02229</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>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH LOSS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131677-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CG-MERCK-1011USA03255</companynumb>
    <primarysource>
      <reportercountry>CONGO</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ONCHOCERCIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101026</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131678-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CG-MERCK-1011USA03251</companynumb>
    <primarysource>
      <reportercountry>CONGO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ONCHOCERCIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101016</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131679-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0909GBR00066</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>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131680-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1011USA03391</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>FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPARATHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERURICAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131681-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0901DEU00075</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>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CAROTID ARTERY STENOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081014</drugenddate>
        <drugtreatmentduration>149</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPIPRAMOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GENERALISED ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CAROTID ARTERY STENOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081010</drugenddate>
        <drugtreatmentduration>145</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ST JOHNS WORT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GENERALISED ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080929</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131682-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-12888BP</companynumb>
    <primarysource>
      <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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC 150</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021698</drugauthorizationnumb>
        <drugdosagetext>150 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101117</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131683-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033778</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>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101122</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131684-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-GENENTECH-303254</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>B6111B01</drugbatchnumb>
        <drugdosagetext>1000 MG, Q15D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100625</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCORT</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>6 MG, Q6H</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIMESULIDE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIOSAN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BESEROL</medicinalproduct>
        <drugdosagetext>100 MG, Q12H</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DORFLEX</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIBUTRAMINE HYDROCHLORIDE MONOHYDRATE</medicinalproduct>
        <drugdosagetext>15 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEFLAZACORT</medicinalproduct>
        <drugdosagetext>6 UNK, Q6H</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131685-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-GENENTECH-310118</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101112</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAREVAN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIO</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>DRUG NAME: CALCIO D</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131686-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0630573-00</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>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOFT TISSUE INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131687-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033909</companynumb>
    <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>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090612</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131688-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010005949</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLAST CELLS PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW RETICULIN FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100924</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131689-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-307033</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>225 MG, Q2W</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULFATE</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>PREDNISONE</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>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>PERCOCET</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>SINGULAIR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131690-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-GENENTECH-304573</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID FACTOR INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1000 MG/ML, 2/MONTH</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091016</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>2 TABLET, 1/WEEK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GINKGO BILOBA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>400 MG, UNK</drugdosagetext>
        <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>7131691-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-12915BP</companynumb>
    <primarysource>
      <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>ZANTAC</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021698</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131692-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TH-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-DE-03853GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugdosagetext>200 MG</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugdosagetext>400 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugdosagetext>60 MG FOR BODY WEIGHT {60 KG AND 80 MG FOR BODY WEIGHT }60 KG</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131693-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TH-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-DE-03856GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugdosagetext>200 MG</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugdosagetext>400 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugdosagetext>60 MG FOR BODY WEIGHT {60 KG AND 80 MG FOR BODY WEIGHT }60 KG</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFAMPICIN</medicinalproduct>
        <drugdosagetext>450 MG PER DAY FOR A BODY WEIGHT {50 KG AND 600 MG PER DAY FOR A BODY WEIGHT }50 KG</drugdosagetext>
        <drugindication>TUBERCULOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugindication>TUBERCULOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHAMBUTOL HYDROCHLORIDE</medicinalproduct>
        <drugindication>TUBERCULOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PYRAZINAMIDE</medicinalproduct>
        <drugindication>TUBERCULOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131694-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-310065</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>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>4 UNK, 4/WEEK</drugdosagetext>
        <drugindication>THROMBOTIC THROMBOCYTOPENIC PURPURA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131695-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-310181</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>TUNNEL VISION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>375 MG/M2, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TREANDA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100921</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131696-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101121</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-ABBOTT-10P-082-0677799-00</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLICATION OF PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REDUCTIL 15MG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020632</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBESITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REDUCTIL 15MG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020632</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131697-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MYLANLABS-2010S1021139</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE</medicinalproduct>
        <drugauthorizationnumb>077166</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE: 75 MG MILLIGRAM(S) EVERY DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100428</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE</medicinalproduct>
        <drugauthorizationnumb>077166</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE: 150 MG MILLIGRAM(S) EVERY DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100505</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE</medicinalproduct>
        <drugauthorizationnumb>077166</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE: 225 MG MILLIGRAM(S) EVERY DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100517</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE</medicinalproduct>
        <drugauthorizationnumb>077166</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE: 150 MG MILLIGRAM(S) EVERY DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100607</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE</medicinalproduct>
        <drugauthorizationnumb>077166</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE: 75 MG MILLIGRAM(S) EVERY DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100609</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131698-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL430196</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100120</drugenddate>
        <drugtreatmentduration>153</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131699-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-MYLANLABS-2010S1021234</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugauthorizationnumb>074046</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XERISTAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131700-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-MYLANLABS-2010S1021234</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugauthorizationnumb>074215</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XERISTAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131701-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MYLANLABS-2010S1021337</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugauthorizationnumb>070920</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080807</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCYCLIDINE HYDROCHLORIDE 2MG TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EXTRAPYRAMIDAL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131702-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010003740</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>APLASIA PURE RED CELL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugdosagetext>40000 UNIT, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100319</drugenddate>
        <drugtreatmentduration>128</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugdosagetext>60000 UNIT, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100419</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugdosagetext>40000 UNIT, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100510</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugdosagetext>60000 UNIT, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
        <drugtreatmentduration>101</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS</medicinalproduct>
        <drugdosagetext>2 UNIT, Q2WK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131703-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HU-AMGEN-HUNNI2010002950</companynumb>
    <primarysource>
      <reportercountry>HUNGARY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARBEPOETIN ALFA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>10 A?G, UNK</drugdosagetext>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMID                          /00032601/</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>2.5 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>2 ML, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIGANTOL                           /00107901/</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPOTHIAZID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORMODIPIN                         /00972401/</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK UNK, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090810</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MALTOFER                           /00383901/</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>5 ML, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK UNK, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINNAT                             /00454601/</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>2 ML, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSPAMOX                            /00249601/</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>2 ML, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>25 A?G, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIORIX VACCINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>8 ML, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131704-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN LTD.-QUU443740</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>185 A?G, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091026</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>85 A?G, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091026</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROID NOS</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUPRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B12                        /00056201/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131705-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MYLANLABS-2010S1021444</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugauthorizationnumb>075716</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>METHYLTHIONINIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>POSTOPERATIVE ANALGESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131706-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MYLANLABS-2010S1021444</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugauthorizationnumb>077873</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>METHYLTHIONINIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>POSTOPERATIVE ANALGESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131707-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TH-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-DE-06429GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugdosagetext>200 MG</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugdosagetext>400 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugdosagetext>60 MG FOR BODY WEIGHT {60 KG AND 80 MG FOR BODY WEIGHT }60 KG</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131708-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-MYLANLABS-2010S1021602</companynumb>
    <primarysource>
      <reportercountry>TURKEY</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>ANORGASMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugauthorizationnumb>076314</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MIGRAINE PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugauthorizationnumb>076314</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugauthorizationnumb>076314</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131709-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-MYLANLABS-2010S1021619</companynumb>
    <primarysource>
      <reportercountry>TURKEY</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>DRUG ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYBUTYNIN</medicinalproduct>
        <drugauthorizationnumb>076644</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SUBSTANCE ABUSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131710-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MYLANLABS-2010S1021628</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>NODULAR REGENERATIVE HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL VARICES HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugauthorizationnumb>090788</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131711-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090316</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-WATSON-2009-11949</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 INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>076685</drugauthorizationnumb>
        <drugdosagetext>40 MG, DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANOLAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDROCORTISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN GLARGINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131712-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080624</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-WATSON-2008-07914</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>076685</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUSIDIC ACID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESLORATADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRIDAMOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131713-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ELI_LILLY_AND_COMPANY-SE201011007453</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</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>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERIPARATIDE</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
        <drugtreatmentduration>567</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>300 MG, 3/D</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FURIX</medicinalproduct>
        <drugdosagetext>40 MG, 2/D</drugdosagetext>
        <drugindication>OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091029</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040406</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091102</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131714-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2010144399</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugauthorizationnumb>008762</drugauthorizationnumb>
        <drugindication>STATUS EPILEPTICUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL</medicinalproduct>
        <drugindication>STATUS EPILEPTICUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131715-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010156713</companynumb>
    <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>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131716-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2010154633</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL TUBE INSERTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131717-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101121</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010154971</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131718-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010156064</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131719-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010155147</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>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HANGOVER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXLANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERCHLORHYDRIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131720-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101121</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010154105</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>BACK DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NERVE INJURY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131721-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010159630</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugauthorizationnumb>020151</drugauthorizationnumb>
        <drugdosagetext>450 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131722-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010155120</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>HIP SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131723-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010129028</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>120.18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETIC NEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
        <drugdosagetext>10/325 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL XL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131724-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006168</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090610</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131725-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-GBRSP2010004573</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>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, WEEKLY</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131726-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-AMGEN-NLDSP2010004506</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, WEEKLY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICHEW-D3</medicinalproduct>
        <drugdosagetext>500 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>25 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIDOXINE HCL</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugdosagetext>300 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>5 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131727-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR201011005234</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPRONIZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANXIOLYTICS</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LINDILANE</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131728-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011005703</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>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 D/F, UNK</drugdosagetext>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131729-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011005262</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>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131730-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011005307</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>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNKNOWN</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131731-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ELI_LILLY_AND_COMPANY-IT201011004857</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugdosagetext>2 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SARTAN</medicinalproduct>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131732-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ELI_LILLY_AND_COMPANY-IT201011004722</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOPOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, 3/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOMOTOR HYPERACTIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100729</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugdosagetext>125 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOMOTOR HYPERACTIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100729</drugenddate>
        <drugtreatmentduration>210</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIBOMET</medicinalproduct>
        <drugdosagetext>80 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITRIN</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSTIDE</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131733-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ELI_LILLY_AND_COMPANY-BE201011004793</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>100</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>UNK, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100602</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>7.5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131734-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ELI_LILLY_AND_COMPANY-BR201011004721</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>GASTROINTESTINAL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>750 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINVASTATINA</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMAZEPAM</medicinalproduct>
        <drugdosagetext>10 MG, EACH EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131735-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-10P-167-0638013-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>TRABECTEDIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1.2 MG/M2 (MILLIGRAM PER SQ. METER). CYCLES 1-3</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SARCOMA METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>TRABECTEDIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1.2 MG/M2. CYCLE 4, 2.4MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLIZINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLIZINE</medicinalproduct>
        <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>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON HCL</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>7131736-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CZ-AMGEN-CZECT2010004118</companynumb>
    <primarysource>
      <reportercountry>CZECH REPUBLIC</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>JOINT ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131737-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-AMGEN-NLDSP2010004516</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG/ML WEEKLY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101108</drugenddate>
        <drugtreatmentduration>1366</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMAZEPAM</medicinalproduct>
        <drugdosagetext>3 MG, 3X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE</medicinalproduct>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131738-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-AMGEN-NLDSP2010004610</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, WEEKLY</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100503</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131739-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AMGEN-DEUSP2010005206</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131740-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AMGEN-QUU436292</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100316</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131741-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2009BI028173</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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGAMENT RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONTROL OF LEGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugbatchnumb>P68059</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070518</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090416</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPYRA</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131742-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI006013</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CALCULUS URETERIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugbatchnumb>P68076</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091012</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131743-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI011535</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>
      <patientweight>67</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MAJOR DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100326</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</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>GEODON</medicinalproduct>
        <drugindication>CONFUSIONAL STATE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131744-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI025878</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>CERVICAL SPINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080218</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPYRA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131745-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BIOGENIDEC-2010BI027530</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>0</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL DRUGS AFFECTING FOETUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYDACTYLY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131746-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100907</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI029597</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>49</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100526</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTEROL</medicinalproduct>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROXICET</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>PROTEIN S DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPY (NOS)</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131747-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-BIOGENIDEC-2010BI029862</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>ABDOMINAL HERNIA OBSTRUCTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMORAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INGUINAL HERNIA, OBSTRUCTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugbatchnumb>P68095</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100923</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131748-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI032260</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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090306</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPRYA (ORAL DALFAMPRIDINE)</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS (NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR (VENLAFAXINE HYDOCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131749-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI040911</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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090325</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030406</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131750-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI040936</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080530</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131751-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041089</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>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETIT MAL EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131752-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041090</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>THROMBOSIS</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>20070530</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131753-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041111</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>KNEE OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090226</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131754-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041146</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>COLONIC STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131755-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BIOGENIDEC-2010BI041226</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPLASTIC NAEVUS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT MELANOMA IN SITU</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100524</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131756-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2010BI004390</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>BUNION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <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>20070502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131757-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2009BI003866</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>BLADDER CANCER</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>20030801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131758-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI024188</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32126</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080109</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131759-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI027663</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</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32119</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020927</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131760-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI031728</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 DELIVERY DEVICE IMPLANTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080510</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131761-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI037238</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>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981019</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131762-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI040118</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>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050815</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131763-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041105</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>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS (NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131764-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041177</companynumb>
    <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 BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000229</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131765-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041439</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>STRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131766-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041466</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020909</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131767-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041694</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>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090312</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131768-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041715</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>RENAL MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131769-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI036093</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>HERPES SIMPLEX</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>20030317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060111</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131770-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI040023</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>72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</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>7131771-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041103</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>CHILLS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100102</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131772-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041441</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 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>19981201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131773-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041476</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>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</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>7131774-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041484</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>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100914</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131775-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041487</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</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>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131776-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041580</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGRAPHIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</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>19990624</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131777-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041590</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>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</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>7131778-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041596</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 HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131779-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041597</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>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101119</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131780-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041599</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>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAIN PILLS (NOS)</medicinalproduct>
        <drugindication>ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131781-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041601</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>EXPOSURE TO COMMUNICABLE DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131782-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041610</companynumb>
    <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>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131783-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041613</companynumb>
    <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>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131784-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041614</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>FEAR</reactionmeddrapt>
      </reaction>
      <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>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131785-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041619</companynumb>
    <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>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131786-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041620</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>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING OF DESPAIR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRUSTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981209</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131787-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041622</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>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131788-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041632</companynumb>
    <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>DRUG SPECIFIC ANTIBODY PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</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>20010801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131789-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041656</companynumb>
    <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 DISORDER</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>7131790-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041657</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>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</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>20101119</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131791-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041697</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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060913</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>20000915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060726</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131792-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041847</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>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REACTION TO PRESERVATIVES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32124</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060421</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131793-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI008266</companynumb>
    <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>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTRACTIBILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGRAPHIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCORIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONTROL OF LEGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERONEAL NERVE PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091030</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131794-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI008345</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>CONJUNCTIVITIS VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</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>20080617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100708</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131795-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI019926</companynumb>
    <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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHONDROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPICONDYLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060830</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131796-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI022038</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEASONAL ALLERGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugbatchnumb>P32116</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091013</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131797-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI022692</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>
      <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>20070607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010203</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131798-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI024523</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>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</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>7131799-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI027205</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>BACK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131800-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI029298</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <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>7131801-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI029388</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>ESCHERICHIA URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090728</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPYRA</medicinalproduct>
        <drugindication>GAIT DISTURBANCE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131802-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI036105</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>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</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>20081217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131803-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI036484</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>
      <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>20071017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080424</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100730</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131804-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI038778</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>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</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>20100430</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131805-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI039356</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>ADVERSE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</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>20101022</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131806-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI040102</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>DRUG SPECIFIC ANTIBODY PRESENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131807-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI040834</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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100629</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080807</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131808-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041204</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>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131809-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041494</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>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101105</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131810-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041498</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>PANIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100809</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131811-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041503</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>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070404</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131812-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041506</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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100427</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131813-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041531</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>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100708</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131814-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041537</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>DRUG SPECIFIC ANTIBODY PRESENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100823</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131815-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041542</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VEIN DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080331</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131816-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041543</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>POOR VENOUS ACCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131817-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041555</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100527</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131818-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041556</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>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100319</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090116</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131819-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041560</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>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STREPTOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100920</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131820-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041562</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>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100310</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131821-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041577</companynumb>
    <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>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131822-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041581</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>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEATED RED CELLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081230</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131823-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041595</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>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101007</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131824-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041608</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090922</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131825-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041611</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020805</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131826-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041612</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>NUCLEATED RED CELLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131827-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041618</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>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090805</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131828-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041624</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100528</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131829-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041628</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</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>20100920</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131830-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041630</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>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090824</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131831-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041635</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>CENTRAL VENOUS CATHETERISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070202</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131832-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041638</companynumb>
    <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>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131833-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041639</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090414</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131834-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041641</companynumb>
    <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>20090828</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131835-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041645</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 IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070725</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021011</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131836-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041646</companynumb>
    <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>20101001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131837-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041647</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>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050216</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131838-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041649</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>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080624</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131839-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041652</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>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080326</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131840-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041655</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 TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131841-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041661</companynumb>
    <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>DECREASED ACTIVITY</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>20080707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081203</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131842-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041664</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>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070307</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131843-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041666</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</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080703</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131844-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041674</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>NASOPHARYNGITIS</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>20080604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131845-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041683</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>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131846-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041690</companynumb>
    <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>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080314</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131847-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041699</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>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131848-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041708</companynumb>
    <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>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100922</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131849-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041712</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <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>20070803</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131850-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041718</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>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090326</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131851-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041725</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101119</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131852-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041728</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>AURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LICHEN PLANUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131853-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041735</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>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100222</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131854-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041740</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100609</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131855-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041742</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>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131856-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041751</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>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080320</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131857-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041757</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS FLOATERS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131858-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041759</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>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS [NOS]</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS RELAPSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131859-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041763</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>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131860-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041764</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>20080730</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131861-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041768</companynumb>
    <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 DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100908</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131862-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041769</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>SEASONAL ALLERGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100219</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131863-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041809</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>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101008</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131864-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041812</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>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090925</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131865-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041819</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>ASTHENIA</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>20100914</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131866-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041820</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>DEPRESSION</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>20100331</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131867-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041822</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>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131868-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041826</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION VIRAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070215</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131869-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041829</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>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</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>20100319</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131870-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041834</companynumb>
    <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>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131871-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041836</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>BRADYPHRENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100113</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131872-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041840</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>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131873-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090814</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2008BI006931</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080311</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131874-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20081208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2008BI033202</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>AGRAPHIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMICEPHALALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131875-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090918</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2009BI030134</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>ORAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090706</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131876-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2009BI031289</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>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</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>20090921</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131877-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2009BI037165</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 INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090420</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131878-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2010BI040240</companynumb>
    <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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131879-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-BAXTER-2010BH027921</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>GAMMAGARD LIQUID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101013</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131880-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-724622</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980424</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131881-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20081001</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-CELGENEUS-056-21880-08100226</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>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070606</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUPRESSYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHYSIOGEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYZAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131882-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028851</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD LIQUID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131883-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20081001</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-CELGENEUS-056-21880-08100256</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>PNEUMONIA VIRAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071112</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131884-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-CELGENEUS-114-20785-10112115</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>109</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugauthorizationnumb>020785</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELPHALAN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100811</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APD</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100802</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100802</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOLON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101015</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBASALATE CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131885-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-CELGENEUS-028-C5013-10112629</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ILIUM FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED INTRAABDOMINAL FLUID COLLECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugauthorizationnumb>020785</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELPHALAN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELPHALAN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101107</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131886-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-CELGENEUS-028-21880-10112627</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131887-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10110991</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>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101026</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131888-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028853</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD LIQUID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131889-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-015677-10</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>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION DURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MUCINEX</medicinalproduct>
        <drugbatchnumb>WO00472021</drugbatchnumb>
        <drugdosagetext>PATIENT TOOK ONE TABLET ONCE OR TWICE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INCREASED UPPER AIRWAY SECRETION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MUCINEX</medicinalproduct>
        <drugbatchnumb>WO00472021</drugbatchnumb>
        <drugdosagetext>NOT USING EVERY DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131890-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-CELGENEUS-028-C5013-10062944</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPERINFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CC-5013</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100609</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
        <drugdosagetext>1-2 TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILK OF MAGNESIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100610</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131891-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-CELGENEUS-056-C5013-10110162</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CC-5013</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>T-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CC-5013</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100323</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131892-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028849</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABNORMAL SENSATION IN EYE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD LIQUID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131893-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-20785-10092432</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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>020785</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101012</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131894-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-CELGENEUS-009-21880-10080898</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TUMOUR FLARE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100811</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100811</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOLOC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM VERLA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131895-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-CELGENEUS-056-21880-10091565</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100301</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100301</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131896-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PFIZER INC-2010156088</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APALLIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131897-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10113083</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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100927</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131898-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2010RR-39601</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>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUPILS UNEQUAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>077977</drugauthorizationnumb>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131899-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-RANBAXY-2010RR-39586</companynumb>
    <primarysource>
      <reportercountry>TURKEY</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>PUPILS UNEQUAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>077977</drugauthorizationnumb>
        <drugdosagetext>50 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>077977</drugauthorizationnumb>
        <drugdosagetext>75 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>UNK MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>0.75 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>15 MG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131900-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2010R1-39797</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>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugauthorizationnumb>076285</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDICOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131901-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2010R1-38127</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>7.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL DRUGS AFFECTING FOETUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIPIPRAZOLE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIHYDROCODEINE BITARTRATE INJ</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>077977</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORETHISTERONE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPRANOLOL HCL</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131902-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-RANBAXY-2010RR-39754</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 GENERALISED EXANTHEMATOUS PUSTULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugauthorizationnumb>076635</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROPLEX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131903-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-RANBAXY-2010RR-39748</companynumb>
    <primarysource>
      <reportercountry>TURKEY</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>AORTIC VALVE REPLACEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CO-TRIMOXAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ENDOCARDITIS BACTERIAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugindication>ENDOCARDITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYNTABALIN</medicinalproduct>
        <drugindication>ENDOCARDITIS BACTERIAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFAMPICIN</medicinalproduct>
        <drugdosagetext>600 MG, UNK</drugdosagetext>
        <drugindication>ENDOCARDITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
        <drugauthorizationnumb>065356</drugauthorizationnumb>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ENDOCARDITIS BACTERIAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131904-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2010R1-38595</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR ACIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugauthorizationnumb>021591</drugauthorizationnumb>
        <drugdosagetext>850 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100910</drugenddate>
        <drugtreatmentduration>4635</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>DOXAZOSIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>DRIED FERROUS SULPHATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD GLUCOSE INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131905-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2010R1-38175</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS OF PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVE BIRTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE LABOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIPIPRAZOLE</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIHYDROCODEINE TABLETS</medicinalproduct>
        <drugdosagetext>30 MG,  1 TO 2 TDS.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE 100MG TABLETS</medicinalproduct>
        <drugauthorizationnumb>077977</drugauthorizationnumb>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORETHISTERONE</medicinalproduct>
        <drugdosagetext>350 UG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>500 MG, TID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091023</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE SODIUM PHOSPHATE DROPS</medicinalproduct>
        <drugdosagetext>0.1 %, BID, TO EACH NOSTRIL.</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090722</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORAMPHENICOL</medicinalproduct>
        <drugdosagetext>0.5 %, QID</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090722</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBAZAM</medicinalproduct>
        <drugdosagetext>10 IM 1 TABLET TWICE DAILY FOR 1 WEEK THAN HALF A TABLET TWICE DAILY FOR 1 WEEK.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPICILLIN SODIUM/SULBACTAM SODIUM</medicinalproduct>
        <drugdosagetext>500/125 TABLETS, TDS</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100326</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugdosagetext>75 MG, TID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugdosagetext>3.35 G/5 ML , 5-10 ML, DAILY.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER</medicinalproduct>
        <drugdosagetext>5 %, PRN, 10 PATCH</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICONAZOLE</medicinalproduct>
        <drugdosagetext>2 %,</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TPN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
        <drugdosagetext>5 MG, PRN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091221</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131906-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010095312</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>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>1 STARTER PACK; CONTINUOUS PACK WITH FOUR REFILLS</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</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>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131907-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-PFIZER INC-2009251663</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugauthorizationnumb>021266</drugauthorizationnumb>
        <drugdosagetext>200 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASPERGILLOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080311</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugauthorizationnumb>021266</drugauthorizationnumb>
        <drugdosagetext>200 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080325</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUTROGIN</medicinalproduct>
        <drugdosagetext>250 UG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>BONE MARROW FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080315</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>75 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OESOPHAGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080308</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFIXIME</medicinalproduct>
        <drugdosagetext>100 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OESOPHAGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080308</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENIRAMINE</medicinalproduct>
        <drugdosagetext>4 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANTIALLERGIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080317</drugenddate>
        <drugtreatmentduration>58</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>169.32 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080228</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZAVEDOS</medicinalproduct>
        <drugdosagetext>40.63 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080225</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131908-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010067265</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBIDOPA + LEVODOPA</medicinalproduct>
        <drugdosagetext>10/100 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TREMOR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBIDOPA + LEVODOPA</medicinalproduct>
        <drugindication>PARAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBIDOPA + LEVODOPA</medicinalproduct>
        <drugindication>PERIPHERAL COLDNESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131909-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHIRE-ALL1-2010-06214</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSRENOL</medicinalproduct>
        <drugauthorizationnumb>021468</drugauthorizationnumb>
        <drugdosagetext>1000 MG, OTHER (WITH EACH MEAL)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131910-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHIRE-SPV1-2010-01388</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYVANSE</medicinalproduct>
        <drugauthorizationnumb>021977</drugauthorizationnumb>
        <drugdosagetext>60 MG, 1X/DAY:QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYVANSE</medicinalproduct>
        <drugauthorizationnumb>021977</drugauthorizationnumb>
        <drugdosagetext>30 MG, 1X/DAY:QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100226</drugstartdate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYVANSE</medicinalproduct>
        <drugauthorizationnumb>021977</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY:QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131911-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHIRE-SPV1-2010-02049</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTUNIV</medicinalproduct>
        <drugauthorizationnumb>022037</drugauthorizationnumb>
        <drugdosagetext>UNK MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYVANSE</medicinalproduct>
        <drugdosagetext>UNK MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131912-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHIRE-SPV1-2010-02054</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>28.571</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GUANFACINE HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>80009130</drugbatchnumb>
        <drugauthorizationnumb>022037</drugauthorizationnumb>
        <drugdosagetext>4 MG, 1X/DAY:QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101122</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GUANFACINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>022037</drugauthorizationnumb>
        <drugdosagetext>UNK MG, 1X/DAY:QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131913-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100927</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-JNJFOC-20101000117</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131914-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RANBAXY-2010US-39635</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>LICHENOID KERATOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
        <drugauthorizationnumb>065007</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131915-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RANBAXY-2010US-39636</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK COMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugauthorizationnumb>019152</drugauthorizationnumb>
        <drugdosagetext>6 G</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131916-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RANBAXY-2010US-39779</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PSEUDOEPHEDRINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>077442</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131917-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-RANBAXY-2010US-37826</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugauthorizationnumb>075556</drugauthorizationnumb>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100727</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EUPANTOL</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100727</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40 MG, IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100727</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ PROPOXYPHENE HCL</medicinalproduct>
        <drugdosagetext>2 TABLETS IN THE EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100727</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BI-PROFENID</medicinalproduct>
        <drugdosagetext>150 MG, IN THE EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100727</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131918-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RANBAXY-2010US-36354</companynumb>
    <primarysource>
      <reportercountry>ALGERIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMAGNESAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugauthorizationnumb>019152</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAZOSIN HCL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANITUMUMAB</medicinalproduct>
        <drugdosagetext>UNK, 1 EVERY 2 WEEK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131919-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RANBAXY-2010US-39744</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>CHOLESTATIC LIVER INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugauthorizationnumb>076134</drugauthorizationnumb>
        <drugdosagetext>10 MG/D, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHINITIS ALLERGIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIAC</medicinalproduct>
        <drugdosagetext>2.5 MG + 6.25 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131920-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRACCO-005551</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>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTIHANCE</medicinalproduct>
        <drugbatchnumb>S0P259A</drugbatchnumb>
        <drugauthorizationnumb>021357</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANGIOGRAM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131921-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>UA-TEVA-XM22-04-254332GER</companynumb>
    <primarysource>
      <reportercountry>UKRAINE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-SMALL CELL LUNG CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XM22 PEG-FILGRASTIM</medicinalproduct>
        <drugdosagetext>BLINDED XM22 6 MG OR PLACEBO</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>COLONY STIMULATING FACTOR PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100726</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XM22 PEG-FILGRASTIM</medicinalproduct>
        <drugdosagetext>BLINDED XM22 6 MG OR PLACEBO</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XM22 PEG-FILGRASTIM</medicinalproduct>
        <drugdosagetext>BLINDED XM22 6 MG OR PLACEBO</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100911</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XM22 PEG-FILGRASTIM</medicinalproduct>
        <drugdosagetext>BLINDED XM22 6 MG OR PLACEBO</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100723</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100818</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugauthorizationnumb>074284</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100725</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugauthorizationnumb>074284</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100820</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugauthorizationnumb>074284</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugauthorizationnumb>074284</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100725</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100820</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100911</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100725</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PULMONARY OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100820</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100725</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PULMONARY OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100820</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOT'HEMA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMINOCAPROIC ACID</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PULMONARY OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETAMSILATE</medicinalproduct>
        <drugindication>PULMONARY OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMIZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PULMONARY OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMIZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLASMA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLASMA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMINOPHYLLINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PULMONARY OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FEBRILE NEUTROPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PULMONARY OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIKETHAMIDE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PULMONARY OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>L-LYSINE AESCINATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PULMONARY OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORGLYCON (CONVALLARIA MAJALIS EXTRACT)</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PULMONARY OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PULMONARY OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COCARBOXYLASE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PULMONARY OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PULMONARY OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INOSINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PULMONARY OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101022</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131922-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-JNJFOC-20101200120</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BULIMIA NERVOSA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugdosagetext>2 TO 5 MG/DAY.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131923-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-JNJFOC-20101200158</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENOPAUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugdosagetext>2-5MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131924-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-JNJFOC-20101200159</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OBSESSIVE-COMPULSIVE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131925-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-015703-10</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>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MUCINEX DM</medicinalproduct>
        <drugbatchnumb>WO00463792</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131926-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101200010</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MATERNAL DRUGS AFFECTING FOETUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRISOMY 21</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEMASOLE</medicinalproduct>
        <drugauthorizationnumb>017481</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRON SUPPLEMENTS</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131927-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101108656</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>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINOBRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugauthorizationnumb>015923</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DISULFIRAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOMIPRAMINE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENZTROPINE MESYLATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAZODONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DONEPEZIL HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131931-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL406386</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>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1015736</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101029</drugenddate>
        <drugtreatmentduration>226</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131932-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RANBAXY-2010US-39818</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>021591</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131936-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2010R1-39791</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMPICILLIN SODIUM/SULBACTAM SODIUM</medicinalproduct>
        <drugdosagetext>375 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131937-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2010R1-38864</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>78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugauthorizationnumb>076990</drugauthorizationnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100906</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugauthorizationnumb>076990</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100916</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131946-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RANBAXY-2010US-39819</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>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>021591</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131947-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-MX-00188MX</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DABIGATRAN ETEXILATE</medicinalproduct>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>220 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>4 G</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMIZOL</medicinalproduct>
        <drugdosagetext>4 G</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZALDIAR</medicinalproduct>
        <drugdosagetext>1 TABLET EVERY 6 HOURS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugdosagetext>750 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131948-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-257300USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NERVE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugauthorizationnumb>020622</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131949-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-257426USA</companynumb>
    <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>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULFATE AUTOHALER</medicinalproduct>
        <drugauthorizationnumb>021457</drugauthorizationnumb>
        <drugdosagetext>PRN</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLESEVELAM HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131950-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-257459USA</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>TOOTH DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULFATE AUTOHALER</medicinalproduct>
        <drugauthorizationnumb>021457</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BROVANA</medicinalproduct>
        <drugdosagetext>15 UG/2ML</drugdosagetext>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LETROZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORMOTEROL FUMARATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131951-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-257475USA</companynumb>
    <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>ALBUTEROL SULFATE AUTOHALER</medicinalproduct>
        <drugbatchnumb>PAA18B</drugbatchnumb>
        <drugauthorizationnumb>021457</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131952-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAXTER-2010BH028176</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>52</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEIBA</medicinalproduct>
        <drugbatchnumb>VNF2K021A</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HAEMOSTASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEIBA</medicinalproduct>
        <drugbatchnumb>VNF2K021A</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACQUIRED HAEMOPHILIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101115</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131959-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028632</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>
      <reaction>
        <reactionmeddrapt>ANTI-HBC ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTI-HBS ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD LIQUID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MYASTHENIA GRAVIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD LIQUID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OFF LABEL USE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORMAL HUMAN IMMUNOGLOBULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>GOUT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVALIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131963-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20100708263</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>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131964-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20100210275</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>9RMKA85501</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>9RMKA85501</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131965-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101001692</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131966-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-JNJFOC-20101108595</companynumb>
    <primarysource>
      <reportercountry>GREECE</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>HODGKIN'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FILICINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131967-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101109023</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131968-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-JNJFOC-20101108994</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>HEARING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODULE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC POTASSIUM</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131975-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101121</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-CUBIST-2010S1000332</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</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>20100515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100519</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131976-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101109088</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>117.94</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <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>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BALSALAZIDE DISODIUM</medicinalproduct>
        <drugdosagetext>5 IN AM  AND 4 IN PM/ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131977-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-CUBIST-2010S1001121</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>
      <patientweight>73</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CREATININE RENAL CLEARANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CUBICIN</medicinalproduct>
        <drugauthorizationnumb>021572</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DEVICE RELATED INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CUBICIN</medicinalproduct>
        <drugauthorizationnumb>021572</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LINEZOLID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMIPENEM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE HYCLATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131978-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-CUBIST-2010S1001576</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENDOCARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CUBICIN</medicinalproduct>
        <drugauthorizationnumb>021572</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ENDOCARDITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100416</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CUBICIN</medicinalproduct>
        <drugauthorizationnumb>021572</drugauthorizationnumb>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LINEZOLID</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100430</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100430</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100430</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131979-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-CUBIST-2010S1001727</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>95</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CUBICIN</medicinalproduct>
        <drugauthorizationnumb>021572</drugauthorizationnumb>
        <drugindication>STAPHYLOCOCCAL BACTERAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100819</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CUBICIN</medicinalproduct>
        <drugauthorizationnumb>021572</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100819</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIPERACILLIN W/TAZOBACTAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100819</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131988-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-RA-00274RA</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>2 CAPSULES DAILY (ONE IN THE MORNING AND ONE AT NIGHT)</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL</medicinalproduct>
        <drugdosagetext>AS REQUIRED</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131989-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ASTRAZENECA-2010SE03673</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARA-2</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131990-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ASTRAZENECA-2010SE55955</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>BLOOD PRESSURE INADEQUATELY CONTROLLED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101123</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANLO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101123</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7131991-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ASTRAZENECA-2010SE06344</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100209</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMALGIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIPLATELET THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METILDOPA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METILDOPA</medicinalproduct>
        <drugdosagetext>HALF A TABLET TWICE A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURAN T4</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132006-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>UG-ABBOTT-10P-165-0658811-00</companynumb>
    <primarysource>
      <reportercountry>UGANDA</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>MALARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALUVIA TABLETS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021906</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALARIA PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100317</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALUVIA TABLETS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021906</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZT</medicinalproduct>
        <drugindication>MALARIA PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100721</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZT</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE (EPIVIR HBV)</medicinalproduct>
        <drugindication>MALARIA PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100317</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE (EPIVIR HBV)</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTRIMOXAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132007-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-NAPPMUNDI-CAN-2010-0001619</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>FEELING OF DESPAIR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUTRANS TRANSDERMAL PATCH</medicinalproduct>
        <drugauthorizationnumb>021306</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132008-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101100720</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>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132016-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010003699</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>3 A?G/KG, UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100825</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132017-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-NAPPMUNDI-GBR-2010-0007421</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>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNIPHYLLIN CONTINUS TABLETS</medicinalproduct>
        <drugauthorizationnumb>087571</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMINOPHYLLINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132023-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006668</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLADDER CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugindication>THROMBOCYTOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091112</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132024-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10112762</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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101022</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132025-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-SANOFI-AVENTIS-200910515DE</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>65.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLEXANE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020164</drugauthorizationnumb>
        <drugdosagetext>DOSE AS USED: 2X0.6 MLDOSE UNIT: .6 ML</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE AS USED: 1-0-1/2 DOSE UNIT: 5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XIPAMIDE</medicinalproduct>
        <drugdosagetext>DOSE AS USED: 10 MG ORAL 2 IN DAY  MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080722</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TORASEMIDE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE AS USED: 10 MG, 5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugdosagetext>DOSE AS USED: 200 MG, 2 IN DAY DOSE UNIT: 200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URBASON</medicinalproduct>
        <drugdosagetext>DOSE UNIT: 10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIANI</medicinalproduct>
        <drugdosagetext>DOSE AS USED: 1 DF DOSAGE FORM</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132026-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13376BP</companynumb>
    <primarysource>
      <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>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</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>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>TRANSIENT ISCHAEMIC ATTACK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICATION NOT FURTHER SPECIFIED</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132027-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-FF-00952FF</companynumb>
    <primarysource>
      <qualification>2</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>PRADAXA</medicinalproduct>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>150 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIP ARTHROPLASTY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132032-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100602</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ASTRAZENECA-2010SE25557</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>QUALITY OF LIFE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugauthorizationnumb>020578</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APO-SALVENT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CADUET</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELOCON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT HFA</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOBUNOLOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132033-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ASTRAZENECA-2010SE55960</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>105</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND HCT</medicinalproduct>
        <drugauthorizationnumb>021093</drugauthorizationnumb>
        <drugdosagetext>16/12.5 MG OD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132034-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006247</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100917</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132035-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010005920</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>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132036-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-ASTRAZENECA-2010SE47362</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugbatchnumb>LF8363</drugbatchnumb>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100720</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugdosagetext>TITRATED TO 32 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100716</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLESTYRAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETRUSITOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132037-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090608</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-ASTRAZENECA-2009SE05002</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</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>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132038-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ASTRAZENECA-2010SE33707</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>EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugauthorizationnumb>018240</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132042-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2010SE55012</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16960</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENISCUS LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101019</drugenddate>
        <drugtreatmentduration>841</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132043-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2010SE55501</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugauthorizationnumb>019777</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>GASTRIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugindication>MACULAR DEGENERATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOMIL</medicinalproduct>
        <drugdosagetext>AS REQUIRED</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132044-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-ASTRAZENECA-2010SE47342</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>110</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugbatchnumb>KC8218</drugbatchnumb>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081215</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132045-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20081001</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-CELGENEUS-056-21880-08100232</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALACYCLOVIR HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPECIAFOLDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132046-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010DE68731</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080220</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132047-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010DE72522</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132048-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010FR79756</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>ARTERIAL THROMBOSIS LIMB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTREMITY NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOE AMPUTATION</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>20090801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORECORMON</medicinalproduct>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132049-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010FR81450</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>ANTIPSYCHOTIC DRUG LEVEL BELOW THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEPONEX</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>600 MG, QD</drugdosagetext>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132050-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010MX78621</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYST REMOVAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>320 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>160 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132051-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-AMGEN-QUU406335</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091209</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>25 MG, QWK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090918</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091209</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132052-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101108907</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>CHILD ABUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugauthorizationnumb>020281</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132053-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040201729</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>52.16</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CUTANEOUS LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <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>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132054-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2010GB04156</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>ANTIPSYCHOTIC DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOITRE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</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>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>350 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>250 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugdosagetext>1250 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100718</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBIMAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101014</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYOSCINE HBR HYT</medicinalproduct>
        <drugdosagetext>300 UG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SALIVARY HYPERSECRETION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132055-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US68993</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY OF PARTNER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TASIGNA</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101007</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TASIGNA</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101010</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132056-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2010GB05125</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>200 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000516</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSED MOOD</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCYCLIDINE HYDROCHLORIDE 2MG TAB</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYOSCINE HBR HYT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132057-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2010GB04637</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL 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>20100929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101005</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101005</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugdosagetext>15 MG, UNK</drugdosagetext>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090326</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132058-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010MX78706</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 PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LITHOTRIPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RASILEZ HCT</medicinalproduct>
        <drugauthorizationnumb>022107</drugauthorizationnumb>
        <drugdosagetext>150/12.5 MG, 1 TABLET DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101111</drugenddate>
        <drugtreatmentduration>211</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132059-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2007GB01803</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>ANTIPSYCHOTIC DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>100MG AM / 500MG PM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000516</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>500 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>200 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugdosagetext>20 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSED MOOD</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCYCLIDINE HYDROCHLORIDE 2MG TAB</medicinalproduct>
        <drugdosagetext>5 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYOSCINE HBR HYT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132060-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2010GB02297</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>INTENTIONAL SELF-INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021219</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugindication>INTENTIONAL SELF-INJURY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132061-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2009CA47217</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREATINE URINE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREATININE RENAL CLEARANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN CELL VOLUME DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED CELL DISTRIBUTION WIDTH INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SERUM FERRITIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG EVERY 6 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090721</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132062-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2009US01787</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC PROCEDURE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETERISATION CARDIAC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY BYPASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COSTOCHONDRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPEN WOUND</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERWEIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE THORACIC PROCEDURE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTPERICARDIOTOMY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THORACOTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR CAUTERISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugauthorizationnumb>021200</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132063-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US79521</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>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132064-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010AU80318</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132065-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US79047</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST LUMP REMOVAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugdosagetext>2.5 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100621</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132066-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-SANOFI-AVENTIS-2010SA071292</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</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>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>021759</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELOKEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROLINGUAL</medicinalproduct>
        <drugdosagetext>1-3 BOOSTS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOMIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOMIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSCOPAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSCOPAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTECORTIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAVOBAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DALTEPARIN SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101117</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132067-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-ASTRAZENECA-2010SE47346</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28913</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugbatchnumb>KC8218</drugbatchnumb>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090605</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN</medicinalproduct>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132068-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ASTRAZENECA-2010SE01138</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>94</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND HCT</medicinalproduct>
        <drugauthorizationnumb>021093</drugauthorizationnumb>
        <drugdosagetext>8/12.5 MG OD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132069-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ASTRAZENECA-2010SE50725</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugbatchnumb>NH3410</drugbatchnumb>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>200 MCG 1 PUFFS, TWO TIMES A DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132070-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010FR80458</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS BULLOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYSIPELAS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICOSE ULCERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
        <drugauthorizationnumb>020261</drugauthorizationnumb>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RASILEZ HCT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITRODERM</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>VASODILATATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIATEC</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGIOTENSIN CONVERTING ENZYME INHIBITOR FOETOPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SECTRAL</medicinalproduct>
        <drugdosagetext>400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHYSIOTENS</medicinalproduct>
        <drugdosagetext>0.4 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>2 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLECAINE LP</medicinalproduct>
        <drugdosagetext>200</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VENTRICULAR ARRHYTHMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132071-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA76638</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</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>RASILEZ</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>150 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOLOC</medicinalproduct>
        <drugdosagetext>40 MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>850 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>25 MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>200 MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>150 MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>0.137 MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132072-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010VE45125</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORADILE</medicinalproduct>
        <drugauthorizationnumb>020831</drugauthorizationnumb>
        <drugdosagetext>TWICE A DAY</drugdosagetext>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
        <drugdosagetext>TWICE A DAY</drugdosagetext>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINNARIZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132073-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP79202</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>51</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALISKIREN/AMOLODIPINE BESYLATE/HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>150 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100807</drugenddate>
        <drugtreatmentduration>132</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAINTATE</medicinalproduct>
        <drugdosagetext>2.5 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100807</drugenddate>
        <drugtreatmentduration>118</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugdosagetext>4 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100412</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANDEL</medicinalproduct>
        <drugdosagetext>80MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100412</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugdosagetext>25 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100412</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMETEC</medicinalproduct>
        <drugdosagetext>20MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100809</drugenddate>
        <drugtreatmentduration>120</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>2.5MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100329</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132074-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010DE79700</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132075-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP76675</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>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INCADRONIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132076-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2010GB02300</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 DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100816</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>150 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100817</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100818</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132081-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US73798</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>BRONCHIAL IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY THROAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM DISCOLOURED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOBI</medicinalproduct>
        <drugauthorizationnumb>050753</drugauthorizationnumb>
        <drugdosagetext>300 MG, BID</drugdosagetext>
        <drugindication>CYSTIC FIBROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>2.5 G, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugdosagetext>1 G, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugdosagetext>250 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugdosagetext>1 CAPSULE 1 TIME DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
        <drugdosagetext>2 PUFFS PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>10 MG DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>150 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugdosagetext>800 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>2 TABLETS EVERY 4 HRS PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMOZYME</medicinalproduct>
        <drugdosagetext>2.5 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFAMPIN</medicinalproduct>
        <drugdosagetext>600 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LINEZOLID</medicinalproduct>
        <drugdosagetext>600 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZTREONAM</medicinalproduct>
        <drugdosagetext>10 GM DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132082-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101128</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA80289</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugdosagetext>9.5 MG/24 HOURS</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100521</drugenddate>
        <drugtreatmentduration>193</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132083-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010TR75227</companynumb>
    <primarysource>
      <reportercountry>TURKEY</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>EXELON</medicinalproduct>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132084-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA54145</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICTURITION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100319</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132085-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CR80735</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>H1N1 INFLUENZA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORADIL</medicinalproduct>
        <drugauthorizationnumb>020831</drugauthorizationnumb>
        <drugdosagetext>12 MCG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFLONIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132086-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010AU81108</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
    </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>STALEVO 100</medicinalproduct>
        <drugauthorizationnumb>021485</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132087-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010AU51272</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA/ZOLEDRONATE T29581+A++OS</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090217</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132088-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-SANOFI-AVENTIS-2010SA066254</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLEXANE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020164</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100827</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132089-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-KINGPHARMUSA00001-K200901424</companynumb>
    <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 PRESSURE INADEQUATELY CONTROLLED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALITONE</medicinalproduct>
        <drugauthorizationnumb>088051</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132090-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-KINGPHARMUSA00001-K200901439</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>BLOOD PRESSURE INADEQUATELY CONTROLLED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALITONE</medicinalproduct>
        <drugauthorizationnumb>088051</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132097-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2010GB05147</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>300 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>1 G, QID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLATE</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG NOCTE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL</medicinalproduct>
        <drugdosagetext>20 MG NOCTE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS FUMARATE</medicinalproduct>
        <drugdosagetext>210 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugdosagetext>50 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIRENZEPINE</medicinalproduct>
        <drugdosagetext>25 MG MANE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132098-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2009IE54068</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>100 MG MANE AND 350 MG NOCTE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPROMAZINE</medicinalproduct>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOTON</medicinalproduct>
        <drugdosagetext>30MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132099-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2010GB05093</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>37.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132106-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20100501956</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132107-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-AVENTIS-2010SA072016</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020164</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132112-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-DE-06572GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY RESTENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELMISARTAN</medicinalproduct>
        <drugauthorizationnumb>020850</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132113-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13426BP</companynumb>
    <primarysource>
      <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>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132114-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13412BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYE PAIN</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>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <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>20101101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132115-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100729</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10070386</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.192</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM LA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EYE VITAMINS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132116-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101027</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>GT-SANOFI-AVENTIS-2010SA066353</companynumb>
    <primarysource>
      <reportercountry>GUATEMALA</reportercountry>
      <qualification>5</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>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugauthorizationnumb>020905</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METICORTEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132117-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006399</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GANGRENE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1021465</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132118-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-ASTRAZENECA-2010SE47358</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugbatchnumb>K28218</drugbatchnumb>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090503</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132119-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-10P-087-0682955-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>25</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFZON FINE GRANULE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050749</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100804</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100804</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132120-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10070645</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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132121-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAUSCH-2010BL005537</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 TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCERATIVE KERATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BESIVANCE</medicinalproduct>
        <drugbatchnumb>547001</drugbatchnumb>
        <drugauthorizationnumb>022308</drugauthorizationnumb>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>PREOPERATIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100929</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BESIVANCE</medicinalproduct>
        <drugbatchnumb>547001</drugbatchnumb>
        <drugauthorizationnumb>022308</drugauthorizationnumb>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>OFF LABEL USE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100929</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOPTIC</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOPTIC</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>PREOPERATIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THERATEARS</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>OCULAR HYPERAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100916</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132122-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100902</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10090270</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>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132123-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>AT-SANOFI-AVENTIS-2010SA071750</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</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>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugauthorizationnumb>020905</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132124-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2010SE55962</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CREATININE RENAL CLEARANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>021399</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101108</drugenddate>
        <drugtreatmentduration>38</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101108</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132125-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GENZYME-THYM-1002123</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>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>APLASTIC ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091109</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132126-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101005317</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</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>REMICADE</medicinalproduct>
        <drugdosagetext>NEXT DOSE WILL BE POSTPONED ON 26-OCT-2010</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132127-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20090906498</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>48</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <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>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132128-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-JNJFOC-20101100426</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPH NODE TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADALIMUMAB</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MERCAPTOPURINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132129-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GENZYME-THYM-1002127</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>APLASTIC ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091109</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132130-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010000509</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>BONE MARROW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOGENETIC ANALYSIS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACROCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARROW HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>80 A?G/KG, UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>160 A?G/KG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081030</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>160 A?G/KG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>85 A?G/KG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>160 A?G/KG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>160 A?G/KG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>80 A?G/KG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>80 A?G/KG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>80 A?G/KG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>40 A?G/KG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>40 A?G/KG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>40 A?G/KG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>40 A?G/KG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>40 A?G/KG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>40 A?G/KG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>40 A?G/KG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090306</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>40 A?G/KG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090313</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>40 A?G/KG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>40 A?G/KG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>40 A?G/KG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>40 A?G/KG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090417</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>40 A?G/KG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>40 A?G/KG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>40 A?G/KG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>40 A?G/KG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>40 A?G/KG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>40 A?G/KG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>40 A?G/KG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090529</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>40 A?G/KG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090529</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>40 A?G/KG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>40 A?G/KG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>60 A?G/KG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090612</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>60 A?G/KG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090612</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>0.12 ML, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>.12 ML, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090626</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>50 UNK, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>50 UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>20 UNK, PRN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>20 UNK, PRN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugdosagetext>200 UNK, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugdosagetext>200 UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTOSEC</medicinalproduct>
        <drugdosagetext>20 UNK, QD</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTOSEC</medicinalproduct>
        <drugdosagetext>20 UNK, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101022</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132131-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101120</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA072687</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>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JEVTANA KIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>201023</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132132-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2010SE52050</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>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAL</medicinalproduct>
        <drugauthorizationnumb>019810</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132133-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2010SE17598</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>306</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>98</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCREATININAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>QUADRIPLEGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</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>
        <drugdosagetext>( 13975 MG)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>( 13975 MG)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULPIRIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOBAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOBAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HIRNAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIBITTOACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARULEON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132135-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GENZYME-THYM-1002120</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>69</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPROLIFERATIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>3.75 MG/KG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>APLASTIC ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100405</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132136-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010005889</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>NPLATE</medicinalproduct>
        <drugindication>THROMBOCYTOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100517</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132137-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20100407909</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>40.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFLAMMATORY BOWEL DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIPLE VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132138-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-JNJFOC-20101104304</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>95</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACILLARY ANGIOMATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAT SCRATCH DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGIOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DACORTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPONDYLOARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIDROSALURETIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMUREL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILEITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132139-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101128</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SA-SANOFI-AVENTIS-2010SA057129</companynumb>
    <primarysource>
      <reportercountry>SAUDI ARABIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>33.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLOSTAR</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APIDRA SOLOSTAR</medicinalproduct>
        <drugauthorizationnumb>021629</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLOSTAR</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS SOLOSTAR</medicinalproduct>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132140-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2010SE01512</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>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIPTANOL</medicinalproduct>
        <drugdosagetext>OD</drugdosagetext>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANCORON</medicinalproduct>
        <drugdosagetext>BID</drugdosagetext>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>BID</drugdosagetext>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>OD</drugdosagetext>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>BID</drugdosagetext>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>BID</drugdosagetext>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURAN T4</medicinalproduct>
        <drugdosagetext>OD</drugdosagetext>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIMETICONE</medicinalproduct>
        <drugdosagetext>OD</drugdosagetext>
        <drugindication>FLATULENCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMARINE</medicinalproduct>
        <drugdosagetext>OD</drugdosagetext>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DRAMIN B6</medicinalproduct>
        <drugdosagetext>TID/PRN</drugdosagetext>
        <drugindication>VOMITING</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132141-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ASTRAZENECA-2010SE52388</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28861</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SOPOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101023</drugenddate>
        <drugtreatmentduration>53</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101023</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101024</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOMOTOR HYPERACTIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101023</drugenddate>
        <drugtreatmentduration>53</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132142-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2010SE49996</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13259</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>450 MG ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100702</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HIBERNA</medicinalproduct>
        <drugdosagetext>900 MG ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100702</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugdosagetext>7600 MG ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100702</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132143-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0685140-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>4.35</patientweight>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132144-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-10P-062-0687214-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>44</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101025</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132145-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-10P-062-0674148-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTIC LYMPHANGIOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132146-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-10P-087-0654323-00</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>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPLIN SR FOR INJECTION 11.25 MG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020708</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPLIN FOR INJECTION 3.75 MG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020011</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080714</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132149-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA063980</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</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLOSTAR</medicinalproduct>
        <drugbatchnumb>OF292A</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>OF292A</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE:13 UNIT(S)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE:14 UNIT(S)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE:13 UNIT(S)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXCEDRIN (MIGRAINE)</medicinalproduct>
        <drugdosagetext>1 PER DAY</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132150-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028378</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>FLUID OVERLOAD</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132151-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MPIJNJ-2010-05000</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LONG QT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TORSADE DE POINTES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021602</drugauthorizationnumb>
        <drugdosagetext>2.2 MG, CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100831</drugenddate>
        <drugtreatmentduration>113</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEVATRIL</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANTIEMETIC SUPPORTIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100831</drugenddate>
        <drugtreatmentduration>113</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100831</drugenddate>
        <drugtreatmentduration>113</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTRIM FORTE EU RHO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACICLOVIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132152-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MPIJNJ-2010-05959</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEPATITIS B</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</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>20090201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132153-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MPIJNJ-2010-05030</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES SIMPLEX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS PARALYTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROGENIC BLADDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URETERIC RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021602</drugauthorizationnumb>
        <drugdosagetext>2.04 MG, CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100827</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOPEMIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100828</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOPEMIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100830</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</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>BAKTAR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>4 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIFUNGAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100903</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TANNALBIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100830</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITRIZOLE</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIFUNGAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100831</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIFUNGAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100913</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugdosagetext>100 UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100918</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100928</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUNGUARD</medicinalproduct>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FUNGAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100921</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100830</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132154-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-SANOFI-AVENTIS-2009SA008658</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILE DUCT STONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080610</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080708</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>5-FU</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080610</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>5-FU</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080709</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080610</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080709</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132155-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENZYME-THYM-1002117</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>TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>125 MG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEART TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101123</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132156-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-EISAI INC.-E2090-01399-SOL-JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CACHEXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRERIEF</medicinalproduct>
        <drugauthorizationnumb>020789</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132160-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-GENZYME-CLOF-1001334</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVOLTRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021673</drugauthorizationnumb>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101114</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IDARUBICIN</medicinalproduct>
        <drugdosagetext>24 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101112</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>400 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132161-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAXTER-2010BH028596</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC ANEURYSM RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>XS6949W</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER</medicinalproduct>
        <drugbatchnumb>XP6868W</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132162-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-SANOFI-AVENTIS-2010SA013167</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED THERAPY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132169-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2010SE41957</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>65.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100828</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOLVADEX</medicinalproduct>
        <drugauthorizationnumb>021109</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBAL DRUGS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132170-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-NOVOPROD-315217</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTAPHANE PENFILL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019959</drugauthorizationnumb>
        <drugdosagetext>20 IU, QD</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090408</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTRAPID HM PENFILL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>SLIDING SCALE 4-6-8 OR 10 UNITS</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090408</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132171-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-NOVOPROD-316910</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORDITROPIN</medicinalproduct>
        <drugbatchnumb>YU60597</drugbatchnumb>
        <drugauthorizationnumb>021148</drugauthorizationnumb>
        <drugdosagetext>1.4 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORDITROPIN</medicinalproduct>
        <drugauthorizationnumb>021148</drugauthorizationnumb>
        <drugdosagetext>1.4 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132172-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-318988</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>PANCREATITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>1.2 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101121</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132173-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-NOVOPROD-318877</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</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>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULATARD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KREDEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMPUGAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALURES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AERIUS                             /01009701/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIOBE                             /01079901/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALCIPOS-D</medicinalproduct>
        <drugdosagetext>500/400 MG/IE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUROFERON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugdosagetext>120 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132174-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-NOVOPROD-318892</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORDITROPIN NORDIFLEX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021148</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRADER-WILLI SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100510</drugenddate>
        <drugtreatmentduration>144</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132175-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-NOVOPROD-317902</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIC COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VICTIM OF CRIME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLIN 70/30</medicinalproduct>
        <drugauthorizationnumb>019991</drugauthorizationnumb>
        <drugindication>OFF LABEL USE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugdosagetext>0.012 G, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SCOPOLAMINE</medicinalproduct>
        <drugdosagetext>0.0004 G, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132176-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-NOVOPROD-317904</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VICTIM OF CRIME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIXTARD HUMAN 70/30</medicinalproduct>
        <drugauthorizationnumb>019991</drugauthorizationnumb>
        <drugindication>OFF LABEL USE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERGOMETRINE MALEATE</medicinalproduct>
        <drugindication>ABORTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132177-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-314440</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>54.422</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugbatchnumb>YZF0151</drugbatchnumb>
        <drugauthorizationnumb>020986</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132178-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-05376BP</companynumb>
    <primarysource>
      <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>COMPULSIVE SHOPPING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSEXUALITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JUDGEMENT IMPAIRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NR</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL TREMOR</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132179-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-DE-06676PO</companynumb>
    <primarysource>
      <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>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DABIGATRAN</medicinalproduct>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132180-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-GENZYME-CERZ-1001227</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEREZYME</medicinalproduct>
        <drugauthorizationnumb>020367</drugauthorizationnumb>
        <drugdosagetext>60 U/KG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GAUCHER'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132181-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2010SE56067</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31191</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AZOTAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101029</drugenddate>
        <drugtreatmentduration>64</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTAQ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101029</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINTROM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ART 50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugdosagetext>2.5 MG/ML SIX DROPS EVERY EVENING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERY-TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132182-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-NOVOPROD-319126</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTRAPID</medicinalproduct>
        <drugauthorizationnumb>019938</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 2 DF DOSAGE FORM EVERY DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100407</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 50 MG MILLIGRAM(S) EVERY DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFEROX 100</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 1 DF DOSAGE FORM EVERY DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOITRE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132183-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SN-NOVOPROD-318233</companynumb>
    <primarysource>
      <reportercountry>DENMARK</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugbatchnumb>YS61123</drugbatchnumb>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>1.6 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRID</medicinalproduct>
        <drugdosagetext>2 MG, BID</drugdosagetext>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100422</drugenddate>
        <drugtreatmentduration>314</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRID</medicinalproduct>
        <drugdosagetext>2 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100812</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>1000 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090529</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>500 MG, TID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090612</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>500 MGX5</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE</medicinalproduct>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
        <drugdosagetext>5/500 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMICRON</medicinalproduct>
        <drugdosagetext>30 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090612</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORFIT</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100422</drugenddate>
        <drugtreatmentduration>175</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>4 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132184-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-NOVOPROD-319110</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULATARD</medicinalproduct>
        <drugbatchnumb>UK</drugbatchnumb>
        <drugauthorizationnumb>019959</drugauthorizationnumb>
        <drugdosagetext>50 IU, QD ( 30 IU MORNING AND 20 IU EVENING)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CERIS</medicinalproduct>
        <drugdosagetext>2 TAB, QD ( 2 TABS IN MORNING)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>1000 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>500 MG, QD  (1 TABLET MORNING AND EVENING)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDENSIEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN                          /00261401/</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132185-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006521</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1021298</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100524</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132187-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DL2010-0952</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>ABORTION INCOMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFEPRISTONE TABLETS, 200 MG (DANCO LABS)</medicinalproduct>
        <drugauthorizationnumb>020687</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABORTION INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800 MCG, BUCCAL</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132188-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-CEPHALON-2010006155</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TREANDA</medicinalproduct>
        <drugauthorizationnumb>022249</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050112</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050112</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132189-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-256405USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugauthorizationnumb>073178</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132190-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-256407USA</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>CARDIOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>076565</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132191-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-A03200903688</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>
      <patientweight>73.48</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONCUSSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST-TRAUMATIC AMNESTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN CR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021774</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN CR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021774</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021774</drugauthorizationnumb>
        <drugdosagetext>DOSE TEXT: TAKES DOSES OF 5MG OR LESS AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021774</drugauthorizationnumb>
        <drugdosagetext>DOSE TEXT: TAKES DOSES OF 7 TO 8 MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>20 MG ALTERNATING WITH 40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLGARD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AS DIRECTED (4-5 TIMES A DAY)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132192-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-015677-10</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>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION DURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MUCINEX</medicinalproduct>
        <drugbatchnumb>WO00472021</drugbatchnumb>
        <drugdosagetext>PATIENT TOOK ONE TABLET ONCE OR TWICE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INCREASED UPPER AIRWAY SECRETION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MUCINEX</medicinalproduct>
        <drugbatchnumb>WO00472021</drugbatchnumb>
        <drugdosagetext>NOT USING EVERY DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPASENT</medicinalproduct>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132193-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AMGEN-DEUSP2010006270</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD PARATHYROID HORMONE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLIA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100828</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132194-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GENZYME-MOZO-1000446</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOZOBIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022311</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HAEMATOPOIETIC STEM CELL MOBILISATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOZOBIL</medicinalproduct>
        <drugauthorizationnumb>022311</drugauthorizationnumb>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132195-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-BAXTER-2010BH028689</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FUNGAL PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>DIABETIC NEPHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132196-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-CEPHALON-2010006156</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>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TREANDA</medicinalproduct>
        <drugauthorizationnumb>022249</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070316</drugenddate>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070316</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132197-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-253156USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUDDEN HEARING LOSS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugauthorizationnumb>061926</drugauthorizationnumb>
        <drugindication>OROPHARYNGEAL PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXILANT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXILANT</medicinalproduct>
        <drugindication>LARYNGEAL ULCERATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132199-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101128</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-SANOFI-AVENTIS-2010SA048368</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugindication>HEAD AND NECK CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132200-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-GENZYME-FABR-1001258</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FABRAZYME</medicinalproduct>
        <drugdosagetext>50 MG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FABRY'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100528</drugenddate>
        <drugtreatmentduration>139</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FABRAZYME</medicinalproduct>
        <drugdosagetext>1 MG/KG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132201-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-JNJFOC-20101107608</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <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>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132202-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KP-ALEXION-A201001483</companynumb>
    <primarysource>
      <reportercountry>KOREA, DEMOCRATIC PEOPLE'S REPUBLIC OF</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIRIS</medicinalproduct>
        <drugdosagetext>600 MG, QW</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAROXYSMAL NOCTURNAL HAEMOGLOBINURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100119</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIRIS</medicinalproduct>
        <drugdosagetext>900 MG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101112</drugenddate>
        <drugtreatmentduration>297</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>2-4 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101126</drugenddate>
        <drugtreatmentduration>1773</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILYMARIN</medicinalproduct>
        <drugdosagetext>2C-3C</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
        <drugtreatmentduration>1281</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEXOFENADINE HCL</medicinalproduct>
        <drugdosagetext>120 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
        <drugtreatmentduration>61</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132203-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033767</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>IDIOPATHIC PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101113</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132204-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GENZYME-FABR-1001672</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>FABRAZYME</medicinalproduct>
        <drugdosagetext>35 MG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FABRY'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FABRAZYME</medicinalproduct>
        <drugdosagetext>70 MG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugdosagetext>160 MG, UNK</drugdosagetext>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
        <drugdosagetext>2 PUFFS</drugdosagetext>
        <drugindication>RESPIRATORY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugindication>GOUT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132208-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-JNJFOC-20101107892</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXIL</medicinalproduct>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugdosagetext>DAY 4</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BORTEZOMIB</medicinalproduct>
        <drugdosagetext>DAYS: 1, 4, 8, AND 11</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>DAYS: 1-2, 4-5, 8-9, 11-12</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132209-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DK-JNJFOC-20101104764</companynumb>
    <primarysource>
      <reportercountry>DENMARK</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>DEMENTIA ALZHEIMER'S TYPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132210-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-JNJFOC-20101107887</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>DOXIL</medicinalproduct>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugdosagetext>DAY 4</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BORTEZOMIB</medicinalproduct>
        <drugdosagetext>DAYS 1, 4, 8 AND 11</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>DAYS 1-2, 4-5, 8-9, 11-12</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132211-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15412166</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>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID SUPPLEMENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132212-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-15407836</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULEPTIL</medicinalproduct>
        <drugdosagetext>FORMLN: NEULEPTIL 4%</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132213-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-15089485</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>
      <patientweight>93</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>5MG/ML; RECENT INF-29MAR2010; 250MG/M2 RECENT DOSE 250MG/M2:15MAR10-5APR10 RESTARTED ON 12APR10</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>ON DAY 1,8 OF 21-DAY CYCLE RECENTINF:15MAR10-5APR10(20DY) RESTRTD WITH 1 IN 3 WK 12APR10 1DF=5AUC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>RECENT INF-22MAR10;1000MG/M2DOSE:ON DAY 1,8 OF 21-DAY CYCLE15MAR10-5APR10 2IN 3 WK RESTD ON 12APR10</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100315</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132214-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BRISTOL-MYERS SQUIBB COMPANY-15413941</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>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RETINAL ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>LAST AND RECENT DOSE:16NOV10 STREG:5MG/ML INTERRUPTED ON 22NOV10</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEAD AND NECK CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
        <drugtreatmentduration>78</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>LAST AND RECENT DOSE:25OCT10 INTERRUPTED ON 22NOV10</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEAD AND NECK CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101025</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CILENGITIDE</medicinalproduct>
        <drugdosagetext>LAST AND RECENT DOSE:16NOV10 INTERRUPTED ON 22NOV10</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEAD AND NECK CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
        <drugtreatmentduration>78</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>LAST AND RECENT DOSE:25OCT10 CONTINOUS INF FROM DAY 1 TO DAY 4 OF CYCLE INTERRUPTED ON 22NOV10</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEAD AND NECK CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101025</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132215-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-BRISTOL-MYERS SQUIBB COMPANY-15226889</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>RECENT INF ON 30JUL10 DF=750/48 UNITS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100730</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>1 DF = 750/48 MG.RECENT INF ON 16JUL10,ALSO 95MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100715</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100715</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FILGRASTIM</medicinalproduct>
        <drugdosagetext>1 DF=48 MILLION IE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100724</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100722</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100722</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100730</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132216-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GENZYME-FABR-1001675</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FABRAZYME</medicinalproduct>
        <drugdosagetext>35 MG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FABRY'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FABRAZYME</medicinalproduct>
        <drugdosagetext>70 MG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugdosagetext>160 MG, UNK</drugdosagetext>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
        <drugdosagetext>2 PUFFS</drugdosagetext>
        <drugindication>RESPIRATORY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugindication>GOUT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132217-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BRISTOL-MYERS SQUIBB COMPANY-15308729</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>ACUTE PSYCHOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>ALSO TAKEN 15MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132218-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-15342363</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>47</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERAMMONAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BARACLUDE</medicinalproduct>
        <drugauthorizationnumb>021797</drugauthorizationnumb>
        <drugdosagetext>20SEP10</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>8-HOUR BAYER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOLAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARGAMATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RYTHMODAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPADEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONILAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAXOBERON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>1DF=5-6-8 UNITS/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>1DF=7 UNITS/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132219-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BRISTOL-MYERS SQUIBB COMPANY-15385040</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100903</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100909</drugenddate>
        <drugtreatmentduration>63</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100909</drugenddate>
        <drugtreatmentduration>63</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOFOLENE</medicinalproduct>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100909</drugenddate>
        <drugtreatmentduration>63</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugdosagetext>8 MG/2 ML</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100909</drugenddate>
        <drugtreatmentduration>63</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugdosagetext>8 MG/4 ML</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100909</drugenddate>
        <drugtreatmentduration>63</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETON</medicinalproduct>
        <drugdosagetext>10 MG/ML</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100909</drugenddate>
        <drugtreatmentduration>63</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132220-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-12602470</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEPHRADINE</medicinalproduct>
        <drugauthorizationnumb>061764</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040122</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132221-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-BRISTOL-MYERS SQUIBB COMPANY-15344344</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>PLEURISY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORENCIA</medicinalproduct>
        <drugdosagetext>WEEK 0, 2, 4, AND THEN EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100809</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>086358</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100809</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRICORT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132222-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BRISTOL-MYERS SQUIBB COMPANY-15366396</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIASTOLIC DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION VENTRICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULAR FILTRATION RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT ATRIAL DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>MOST RECENT DOSE ON 04OCT2010.NO OF INFUSIONS:9.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101004</drugenddate>
        <drugtreatmentduration>59</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>MOST RECENT INFUSION ON 20SEP2010.ON DAY 1 OF CYCLE.DOSE REDUCED TO 60MG/M2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100920</drugenddate>
        <drugtreatmentduration>45</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>TABLET.ON DAY 1-15; MOST RECENT INFUSION ON 04OCT2010.DOSE REDUCED TO 750MG/M2</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101004</drugenddate>
        <drugtreatmentduration>59</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132223-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-15411820</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>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>DOSE INCREASED TO 30MG</drugdosagetext>
        <drugindication>SCHIZOPHRENIA, DISORGANISED TYPE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132224-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-BRISTOL-MYERS SQUIBB COMPANY-15413339</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>ACUTE PSYCHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugauthorizationnumb>021360</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CYCLOSERINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETHAMBUTOL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRAZINAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFAMPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STREPTOMYCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132227-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GENZYME-FABR-1001676</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MYECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FABRAZYME</medicinalproduct>
        <drugdosagetext>70 MG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FABRY'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugdosagetext>160 MG, UNK</drugdosagetext>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
        <drugdosagetext>2 PUFFS</drugdosagetext>
        <drugindication>RESPIRATORY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugindication>GOUT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132228-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2010158431</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>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOBACCO USER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132230-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENZYME-CERZ-1001674</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>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEREZYME</medicinalproduct>
        <drugauthorizationnumb>020367</drugauthorizationnumb>
        <drugdosagetext>3600 U, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GAUCHER'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEREZYME</medicinalproduct>
        <drugauthorizationnumb>020367</drugauthorizationnumb>
        <drugdosagetext>3600 U, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100216</drugenddate>
        <drugtreatmentduration>4117</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEREZYME</medicinalproduct>
        <drugauthorizationnumb>020367</drugauthorizationnumb>
        <drugdosagetext>2000 U, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101012</drugenddate>
        <drugtreatmentduration>224</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugdosagetext>70 MG, 1X/W</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugdosagetext>80 MG, Q12HR</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>200 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZAVESCA</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GAUCHER'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132231-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHIRE-SPV1-2010-02018</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53.061</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>489 (LISDEXAMFETAMINE DIMESYLATE)</medicinalproduct>
        <drugbatchnumb>80017153A</drugbatchnumb>
        <drugauthorizationnumb>021977</drugauthorizationnumb>
        <drugdosagetext>30 MG, 1X/DAY:QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INVESTIGATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132232-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>UA-SANOFI-AVENTIS-2010SA071250</companynumb>
    <primarysource>
      <reportercountry>UKRAINE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>94</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROTIC RETINOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOVENOUS FISTULA OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC RETINOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDROTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100304</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN INJECTION</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100304</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132233-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2008BH010988</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOPULMONARY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODYNAMIC INSTABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLACTACIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL DRAINAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL EMPYEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INTRAVENOUS CATHETER MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CRANIECTOMY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SUBDURAL EMPYEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>051</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>051</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>051</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERSED</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THROMBIN LOCAL SOLUTION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACITRACIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFOTAXIME SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUMIN (HUMAN)</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>TEARISOL</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACRI-LUBE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAPAVERINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADENOSINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPINEPHRINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUMAZENIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NALOXONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCAINAMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFUROXIME</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132235-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CEPHALON-2010005940</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>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE FOR UNAPPROVED INDICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG PRESCRIBING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE ODOUR ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugbatchnumb>PA30310</drugbatchnumb>
        <drugauthorizationnumb>020717</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHOSPHA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132236-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2008BH010990</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>73</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIC-ISCHAEMIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>010</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080423</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>047056</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080422</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>097081</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080422</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>107024</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080422</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>107064</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080422</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>107066</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080422</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>107074</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080422</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>107111</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080422</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHOSLO</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>REGLAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSRENOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PHOSPHORUS INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCERNA ^ROSS^</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MEDICAL DIET</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULCOLAX</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GUAIFENESIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHOSLO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PHOSPHORUS INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTEIN SUPPLEMENTS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MEDICAL DIET</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INFLUENZA VACCINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INFLUENZA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMCINOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIGAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENGERIX-B</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZEMPLAR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERRLECIT                               /USA/</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMYCIN-MP</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <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>VYTORIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEFLEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132243-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20091100675</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BOVINE TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BCG VACCINE</medicinalproduct>
        <drugindication>IMMUNISATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132244-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2009BH010291</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>79</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPARIN-INDUCED THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOPHLEBITIS SUPERFICIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INTRACARDIAC THROMBUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INTRACARDIAC THROMBUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070713</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070713</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEPIRUDIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INTRACARDIAC THROMBUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070813</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEPIRUDIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070813</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIVALIRUDIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEART TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070725</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIVALIRUDIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070725</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</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>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</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>K-DUR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLCYSTEINE</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>AMBIEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAZOLAM</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>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <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>TYLENOL-500</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070628</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132245-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2010GB05212</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>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</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>20080130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
        <drugtreatmentduration>1009</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INTERFERON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>180 UG /WEEK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>600 MG AT NIGHT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIPIPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132246-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US78769</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONGESTIVE CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>600 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132247-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2009US19061</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132248-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2009NL06882</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADHESIOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROSTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON EXELON+SOL</medicinalproduct>
        <drugauthorizationnumb>021025</drugauthorizationnumb>
        <drugdosagetext>1.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DELIRIUM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090529</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON EXELON+SOL</medicinalproduct>
        <drugauthorizationnumb>021025</drugauthorizationnumb>
        <drugdosagetext>1.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON EXELON+SOL</medicinalproduct>
        <drugauthorizationnumb>021025</drugauthorizationnumb>
        <drugdosagetext>1.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON EXELON+SOL</medicinalproduct>
        <drugauthorizationnumb>021025</drugauthorizationnumb>
        <drugdosagetext>4.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON EXELON+SOL</medicinalproduct>
        <drugauthorizationnumb>021025</drugauthorizationnumb>
        <drugdosagetext>3 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090602</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132249-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP22926</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugauthorizationnumb>019201</drugauthorizationnumb>
        <drugdosagetext>25 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugauthorizationnumb>019201</drugauthorizationnumb>
        <drugdosagetext>50 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTERVERTEBRAL DISC PROTRUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100312</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUROTROPIN</medicinalproduct>
        <drugdosagetext>4 DF, (16 IU)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100312</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100312</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPEL</medicinalproduct>
        <drugdosagetext>150 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100311</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132251-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US78209</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL ARTERIAL OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR GRAFT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101015</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132252-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA78944</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>METASTASES TO LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LYMPH NODES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950806</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132253-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010FR79555</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PACKED RED BLOOD CELL TRANSFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugauthorizationnumb>019201</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUPHYLLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRICANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAROXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OGAST</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132254-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010NL02309</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL FAECES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON EXELON+SOL</medicinalproduct>
        <drugauthorizationnumb>021025</drugauthorizationnumb>
        <drugdosagetext>1.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DELIRIUM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON EXELON+SOL</medicinalproduct>
        <drugauthorizationnumb>021025</drugauthorizationnumb>
        <drugdosagetext>1.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON EXELON+SOL</medicinalproduct>
        <drugauthorizationnumb>021025</drugauthorizationnumb>
        <drugdosagetext>1.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON EXELON+SOL</medicinalproduct>
        <drugauthorizationnumb>021025</drugauthorizationnumb>
        <drugdosagetext>1.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON EXELON+SOL</medicinalproduct>
        <drugauthorizationnumb>021025</drugauthorizationnumb>
        <drugdosagetext>3 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON EXELON+SOL</medicinalproduct>
        <drugauthorizationnumb>021025</drugauthorizationnumb>
        <drugdosagetext>3 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON EXELON+SOL</medicinalproduct>
        <drugauthorizationnumb>021025</drugauthorizationnumb>
        <drugdosagetext>3 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON EXELON+SOL</medicinalproduct>
        <drugauthorizationnumb>021025</drugauthorizationnumb>
        <drugdosagetext>3 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON EXELON+SOL</medicinalproduct>
        <drugauthorizationnumb>021025</drugauthorizationnumb>
        <drugdosagetext>4.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON EXELON+SOL</medicinalproduct>
        <drugauthorizationnumb>021025</drugauthorizationnumb>
        <drugdosagetext>4.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON EXELON+SOL</medicinalproduct>
        <drugauthorizationnumb>021025</drugauthorizationnumb>
        <drugdosagetext>4.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUFENTANIL CITRATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SEDATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOBUTAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOREPINEPHRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROMYCINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORTHALIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPROMELLOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETOMIDATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUTAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAZOCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL W/IPRATROPIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUIMUCIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM HYDROXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DROPERIDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGULAR INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOL ^ALPHARMA^</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCURONIUM BROMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132255-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH005741</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>ARTERIOSCLEROSIS CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CORONARY ARTERY BYPASS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080307</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132256-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-15407703</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>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA ACIDOTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APROVEL TABS 300 MG</medicinalproduct>
        <drugauthorizationnumb>020757</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMPETACT</medicinalproduct>
        <drugdosagetext>1DF=15MG/850MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANDEMRIX</medicinalproduct>
        <drugbatchnumb>A81CA103A</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>H1N1 INFLUENZA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BI-PROFENID</medicinalproduct>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVIGARD PAC (COPACKAGED)</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLIAN</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XATRAL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091122</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132257-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US79226</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132258-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP69270</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCHLORAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100922</drugenddate>
        <drugtreatmentduration>49</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>8-HOUR BAYER</medicinalproduct>
        <drugdosagetext>100MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
        <drugdosagetext>10MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>2.5MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTIST</medicinalproduct>
        <drugdosagetext>10MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>1MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070811</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCORAN</medicinalproduct>
        <drugdosagetext>500MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BASEN</medicinalproduct>
        <drugdosagetext>0.9MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYSLEE</medicinalproduct>
        <drugdosagetext>10MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090502</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132259-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010IT78315</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>CHOLECYSTITIS INFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEFERASIROX</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>20 MG/KG, UNK</drugdosagetext>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEFERASIROX</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>10 MG/KG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEFERASIROX</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>20 MG/KG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEFERASIROX</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>10 MG/KG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANSFUSIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132260-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US75916</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOPEDIC PROCEDURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</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>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132261-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010AU41473</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070814</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132262-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2010GB05196</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>BONE OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUMERUS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
        <drugtreatmentduration>776</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>25 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>7 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
        <drugdosagetext>40 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>20 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>40 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROTIGOTINE</medicinalproduct>
        <drugdosagetext>16 MG DAILY</drugdosagetext>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STALEVO 100</medicinalproduct>
        <drugdosagetext>6 DF DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE</medicinalproduct>
        <drugdosagetext>50 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132263-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2008GB09281</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>ANTIPSYCHOTIC DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN SCAN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>500 MG, QD</drugdosagetext>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>350 MG/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>150 MG MANE, 200 MG NOCTE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>200MG MANE, 300MG NOCTE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>350 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100713</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>175 MG (50 MG MANE, 125 MG NOCTE)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>100 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>150 MG PER DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>200 MG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132264-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA78193</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKULL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101114</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132265-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010MT79239</companynumb>
    <primarysource>
      <reportercountry>MALTA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>160 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>5MG DAILY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132266-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US76438</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IMMUNOGLOBULIN G ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>750 MG/ DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132268-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU434810</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1018474</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100815</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132269-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU434302</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACARODERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>360 A?G, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOCYTOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101112</drugenddate>
        <drugtreatmentduration>270</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>1000 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugdosagetext>1 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODIOL</medicinalproduct>
        <drugdosagetext>300 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>1 MG, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugdosagetext>500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>300 MG, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugdosagetext>30 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>10 MG, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACICLOVIR</medicinalproduct>
        <drugdosagetext>400 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POSACONAZOLE</medicinalproduct>
        <drugdosagetext>200 MG, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM + SULFAMETHOXAZOLE</medicinalproduct>
        <drugdosagetext>UNK UNK, 3 TIMES/WK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMCINOLONE</medicinalproduct>
        <drugdosagetext>.5 %, BID</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
        <drugdosagetext>1 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>20 MEQ, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>UNK UNK, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugdosagetext>600 MG, QWK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>4 MG, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugdosagetext>400 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DASATINIB</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugdosagetext>1 DF, QOD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugdosagetext>1 DF, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VACCINES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132270-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA61552</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URAEMIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UROSEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>350 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100906</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOLTERODINE TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
        <drugdosagetext>100 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARSITAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugdosagetext>30 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTHROTEC</medicinalproduct>
        <drugdosagetext>60 MG, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HCT</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>500 MG, BID</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132271-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2010GB05266</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>CATATONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</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>20031126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101109</drugenddate>
        <drugtreatmentduration>2541</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132272-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2009US66720</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132273-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP75238</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>26.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugauthorizationnumb>019201</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132274-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US62453</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>500 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SIDEROBLASTIC ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>500 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HAEMOCHROMATOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1500 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100919</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>500 MG, QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132275-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CH78548</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DEFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>80 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101007</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132276-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR78994</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>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugdosagetext>ONE TABLET DAILY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132277-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA78935</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ORTHOPEDIC PROCEDURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101117</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132278-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP61839</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</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>20100610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100909</drugenddate>
        <drugtreatmentduration>92</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INTERFERON ALFA</medicinalproduct>
        <drugdosagetext>6000000 IU, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061009</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132279-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010AT78926</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN TRIPLE DTR+TAB</medicinalproduct>
        <drugauthorizationnumb>022314</drugauthorizationnumb>
        <drugdosagetext>160/10/12.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100612</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132281-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US75455</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL SENSATION IN EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1500 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD TRANSFUSION, AUXILIARY PRODUCTS</medicinalproduct>
        <drugdosagetext>3 UNITS OF 3 WEEKS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS</medicinalproduct>
        <drugdosagetext>3 UNITS EVERY 3 WEEK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132282-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2009JP23785</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>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE STIMULATION TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugauthorizationnumb>019201</drugauthorizationnumb>
        <drugdosagetext>75MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYONAL</medicinalproduct>
        <drugdosagetext>15 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOTIFEN FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHARYNGITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132283-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US67924</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132284-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US79087</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1000 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LYMPHOCYTE COUNT ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132285-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2009CY42365</companynumb>
    <primarysource>
      <reportercountry>CYPRUS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL COLIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>20 MG/KG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090817</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>26 MG/KG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>20 MG/KG/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100514</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132286-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA79882</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>ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRANIOTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132288-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2010US02022</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.43</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FULL BLOOD COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THALASSAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132289-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US79364</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132290-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010AU79412</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>NEUTROPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>275 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132291-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP66549</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100830</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
        <drugdosagetext>24 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100816</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUNITINIB MALATE</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100528</drugenddate>
        <drugtreatmentduration>51</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100802</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXINORM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100802</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAIXAN</medicinalproduct>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100802</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugdosagetext>0.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100802</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOTEC</medicinalproduct>
        <drugdosagetext>300 ?G, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100802</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMITT</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100816</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAL</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100802</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALONAL</medicinalproduct>
        <drugdosagetext>800 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100802</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132292-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2010GB05468</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>OVERDOSE</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>20000912</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132293-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010DE15450</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONCOMITANT DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMN107 AMN+CAP</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101028</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMN107 AMN+CAP</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>NO TREATMENT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101111</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMN107 AMN+CAP</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>800 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIDAZOLAM COMP-MID+</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100930</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132294-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GENZYME-CERZ-1001365</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>CEREZYME</medicinalproduct>
        <drugauthorizationnumb>020367</drugauthorizationnumb>
        <drugdosagetext>60 U, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GAUCHER'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100610</drugenddate>
        <drugtreatmentduration>394</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132295-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH023964</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>ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132296-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2008AU24727</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STALEVO 100</medicinalproduct>
        <drugauthorizationnumb>021485</drugauthorizationnumb>
        <drugdosagetext>150 MG, 5QD</drugdosagetext>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MODOPAR</medicinalproduct>
        <drugdosagetext>200 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132297-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010IN80546</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASUNRA</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>400 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132298-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US80131</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>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100715</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132299-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP80590</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>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>NEPHROTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLORIC</medicinalproduct>
        <drugindication>NEPHROTIC SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEVALOTIN</medicinalproduct>
        <drugindication>NEPHROTIC SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132300-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR23625</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELIDEL</medicinalproduct>
        <drugauthorizationnumb>021302</drugauthorizationnumb>
        <drugdosagetext>30 GRAM, 1 APPLICATION AT NIGHT</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>RASH</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132301-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR25486</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>018927</drugauthorizationnumb>
        <drugdosagetext>5ML, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>018927</drugauthorizationnumb>
        <drugdosagetext>7ML, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>018927</drugauthorizationnumb>
        <drugdosagetext>2 %, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132302-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010MX80854</companynumb>
    <primarysource>
      <reportercountry>MEXICO</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>EXFORGE HCT</medicinalproduct>
        <drugauthorizationnumb>022314</drugauthorizationnumb>
        <drugdosagetext>1 TABLET PER DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132303-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033695</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>HEPATIC NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132304-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-SANOFI-AVENTIS-2010SA071330</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUTOPEN 24</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETHINYLESTRADIOL/GESTODENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENSTRUAL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugdosagetext>ACCORDING TO GLYCEMIA</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132305-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH024427</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>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132306-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010FR18073</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APPENDICITIS PERFORATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CERTICAN</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEART TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEART TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090731</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091010</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLUPRED</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHYSIOTENS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELISOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMAREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XATRAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASTAREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIATEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132307-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US81253</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>FEMARA</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100120</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132308-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR50277</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020823</drugauthorizationnumb>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132309-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2009DE10986</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AXILLARY MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CGS 20267 T30748+TAB</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070821</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132310-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101007935</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>BOVINE TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TICE BCG</medicinalproduct>
        <drugindication>IMMUNISATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132311-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA-2010-0054927</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>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022272</drugauthorizationnumb>
        <drugdosagetext>240 MG, BID</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132313-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GENZYME-THYM-1002126</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>APLASTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>APLASTIC ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132314-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-256388USA</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>CARDIOTOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugauthorizationnumb>040333</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132315-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-256363USA</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>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>074739</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132316-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BIOGENIDEC-2010BI041367</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>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132317-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GENZYME-THYM-1002131</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>GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1.25 MG/KG, ONCE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GRAFT VERSUS HOST DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132318-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028302</companynumb>
    <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 DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132323-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NAPPMUNDI-USA-2010-0055872</companynumb>
    <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 ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEEDLE TRACK MARKS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022272</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132324-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028347</companynumb>
    <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 COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GANGRENE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132326-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NAPPMUNDI-USA-2010-0055946</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BEDRIDDEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCOHERENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022272</drugauthorizationnumb>
        <drugdosagetext>40 MG, QID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132327-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028795</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</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132328-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US80090</companynumb>
    <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>FOCALIN</medicinalproduct>
        <drugauthorizationnumb>021278</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132329-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2010GB05093</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>37.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132330-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GENZYME-FABR-1001674</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>UTERINE PROLAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FABRAZYME</medicinalproduct>
        <drugdosagetext>35 MG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FABRY'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FABRAZYME</medicinalproduct>
        <drugdosagetext>70 MG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugdosagetext>160 MG, UNK</drugdosagetext>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
        <drugdosagetext>2 PUFFS</drugdosagetext>
        <drugindication>RESPIRATORY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugindication>GOUT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132331-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101121</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028818</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>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132336-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA79628</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON CANCER RECURRENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMBOLISM ARTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugindication>COGNITIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugdosagetext>25 MG ONCE A WEEK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAVIK</medicinalproduct>
        <drugdosagetext>1 CAPSULE DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM 500</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>400 BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugdosagetext>1 DF, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugdosagetext>1- 2 PUFFS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
        <drugdosagetext>ONE TO TWO INHALATION BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
        <drugdosagetext>1-2 TABS PRN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132337-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ABBOTT-10P-114-0686894-00</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>4.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugbatchnumb>86922TF,91681TF</drugbatchnumb>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugbatchnumb>86922TF,91681TF</drugbatchnumb>
        <drugadministrationroute>051</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101118</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>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132338-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-10P-087-0646233-00</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100507</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100514</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>10 MG DAILY DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100407</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZALTOPROFEN</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000322</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100428</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugindication>GASTRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132339-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH029005</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>INGUINAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONEAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132340-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NAPPMUNDI-USA-2010-0051801</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022272</drugauthorizationnumb>
        <drugdosagetext>10 MG, Q12H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101028</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN/TAXOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK NG/ML, UNK</drugdosagetext>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132346-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010005908</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>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100813</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132347-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA-2010-0054315</companynumb>
    <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>COLLAPSE OF LUNG</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022272</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132348-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENZYME-FABR-1001636</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FABRAZYME</medicinalproduct>
        <drugbatchnumb>A0017A01</drugbatchnumb>
        <drugdosagetext>70 MG, QOW</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FABRY'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FABRAZYME</medicinalproduct>
        <drugdosagetext>35 MG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL PM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132349-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20091100676</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE LABOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <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>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132350-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101108574</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SPINAL FUSION SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132351-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-254187USA</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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132352-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-256429USA</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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARAVIS</medicinalproduct>
        <drugauthorizationnumb>076135</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132353-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-256381USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>080738</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132354-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-US-WYE-H18296510</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>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>021110</drugauthorizationnumb>
        <drugdosagetext>1 MG, 5X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIONEURONAL TUMOUR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>800 MG (LIQUID), 2X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132355-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-US-WYE-H17843510</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED *NO SUBJECT DRUG</medicinalproduct>
        <drugdosagetext>VANUTIDE CRIDIFICAR 3 UG AND QS-21 AT 50 UG</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090916</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED ACC-001</medicinalproduct>
        <drugdosagetext>VANUTIDE CRIDIFICAR 3 UG AND QS-21 AT 50 UG</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090916</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED ACC-001, QS-21</medicinalproduct>
        <drugdosagetext>VANUTIDE CRIDIFICAR 3 UG AND QS-21 AT 50 UG</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090916</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED QS-21</medicinalproduct>
        <drugdosagetext>VANUTIDE CRIDIFICAR 3 UG AND QS-21 AT 50 UG</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090916</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED *NO SUBJECT DRUG</medicinalproduct>
        <drugdosagetext>VANUTIDE CRIDIFICAR 3 UG AND QS-21 AT 50 UG</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100317</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED ACC-001</medicinalproduct>
        <drugdosagetext>VANUTIDE CRIDIFICAR 3 UG AND QS-21 AT 50 UG</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100317</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED ACC-001, QS-21</medicinalproduct>
        <drugdosagetext>VANUTIDE CRIDIFICAR 3 UG AND QS-21 AT 50 UG</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100317</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED QS-21</medicinalproduct>
        <drugdosagetext>VANUTIDE CRIDIFICAR 3 UG AND QS-21 AT 50 UG</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100317</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DONEPEZIL HCL</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>200 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENSURE PLUS</medicinalproduct>
        <drugdosagetext>4 CANS PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGESTROL</medicinalproduct>
        <drugdosagetext>625 MG PER 5ML, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100818</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132356-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-JP-WYE-H15644610</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOSYN</medicinalproduct>
        <drugauthorizationnumb>050684</drugauthorizationnumb>
        <drugdosagetext>4.5 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100105</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
        <drugdosagetext>1 G, 1X/DAY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091221</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAZUCROSS</medicinalproduct>
        <drugdosagetext>1000 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091225</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132357-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA-2010-0052239</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>68.027</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BREAKTHROUGH PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM TREMENS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022272</drugauthorizationnumb>
        <drugdosagetext>10 MG, BID</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101029</drugenddate>
        <drugtreatmentduration>40</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132358-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-256370USA</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>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugauthorizationnumb>077396</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BROMISOVAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132366-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PURDUE-USA-2010-0055943</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</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>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021745</drugauthorizationnumb>
        <drugdosagetext>200 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</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>TRAZODONE</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>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERSYL                           /00790702/</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <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>7132374-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-SANOFI-AVENTIS-2010SA059533</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PERIPHERAL MOTOR NEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021759</drugauthorizationnumb>
        <drugdosagetext>1 IN 14 DAYS</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021759</drugauthorizationnumb>
        <drugdosagetext>1 IN 14 DAYS</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVESTIGATIONAL DRUG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1 IN 14 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVESTIGATIONAL DRUG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1 IN 14 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100729</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVESTIGATIONAL DRUG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>5-FU</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>5-FU</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100318</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100318</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100411</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100411</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>TWICE PER DAY EVERY CYCLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100912</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100218</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100218</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100409</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100409</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100703</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100703</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPHENAMINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100218</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPHENAMINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100218</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPHENAMINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100409</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPHENAMINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100409</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPHENAMINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100703</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPHENAMINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100703</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOTIAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100302</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
        <drugdosagetext>10 TO 20 CC GARGLE</drugdosagetext>
        <drugindication>STOMATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
        <drugdosagetext>10 TO 20 CC GARGLE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100320</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100404</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100519</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER</medicinalproduct>
        <drugdosagetext>20 TO 30 CC GARGLE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100409</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>WOUND COMPLICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100411</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100411</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WOUND COMPLICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100418</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100418</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100410</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100410</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugindication>ABDOMINAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY RETENTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100603</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN AND CLAVULANATE POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WOUND COMPLICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN AND CLAVULANATE POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUGH SYRUP</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100708</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUGH SYRUP</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100718</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100707</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZYDAMINE</medicinalproduct>
        <drugdosagetext>GARGLE FREQUENTLY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100710</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100729</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBROXOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100718</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100519</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132375-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13432BP</companynumb>
    <primarysource>
      <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>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101130</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132376-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13427BP</companynumb>
    <primarysource>
      <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>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101130</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132377-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-ABBOTT-10P-066-0684049-00</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEMPLAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020819</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPERPARATHYROIDISM SECONDARY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOVELEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANTIPLATELET THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASTAREL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTERIOSCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLOPEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLORIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MADOPAR</medicinalproduct>
        <drugdosagetext>1/4 TABLET, 4 TIMES A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132378-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-DE-06455GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC HYPEROSMOLAR COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODYNAMIC INSTABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE + ZIDOVUDINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132379-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-10P-087-0683450-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>41.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFZON</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050749</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIOFERMIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SENEGA SYRUP</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMEZINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MUCOTRON</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132380-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CL-PFIZER INC-CL-WYE-H16854910</companynumb>
    <primarysource>
      <reportercountry>CHILE</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>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091127</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132382-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-FR-WYE-G05703010</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>29</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugauthorizationnumb>020589</drugauthorizationnumb>
        <drugdosagetext>1 DOSE FORM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100212</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITROMAX</medicinalproduct>
        <drugdosagetext>600 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100212</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HELICIDINE</medicinalproduct>
        <drugdosagetext>15 ML, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100212</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132383-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-JP-WYE-H09355109</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>55</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANCARON</medicinalproduct>
        <drugauthorizationnumb>018972</drugauthorizationnumb>
        <drugdosagetext>100.0 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VENTRICULAR FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071110</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANCARON</medicinalproduct>
        <drugdosagetext>17 ML/HR (CONCENTRATION 1.5 MG/ML)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071013</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071110</drugenddate>
        <drugtreatmentduration>38</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071110</drugenddate>
        <drugtreatmentduration>38</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071110</drugenddate>
        <drugtreatmentduration>38</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIGMART</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071110</drugenddate>
        <drugtreatmentduration>38</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEKALANT HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071110</drugenddate>
        <drugtreatmentduration>38</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOGMATYL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071110</drugenddate>
        <drugtreatmentduration>38</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TICLOPIDINE HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071110</drugenddate>
        <drugtreatmentduration>38</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071110</drugenddate>
        <drugtreatmentduration>38</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132384-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-PFIZER INC-IT-WYE-H18363810</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMSIROLIMUS</medicinalproduct>
        <drugauthorizationnumb>022088</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>*BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>10 MG/KG, EVERY 2 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101025</drugenddate>
        <drugtreatmentduration>61</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100810</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEBIVOLOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BARNIDIPINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100810</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132390-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-737030</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIHYDROPYRIMIDINE DEHYDROGENASE DEFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>FREQUENCY: 14 DAYS/ 21 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132391-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-SANOFI-AVENTIS-2010SA071968</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>46</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOMAGNESAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>HYPOPHARYNGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>HYPOPHARYNGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>HYPOPHARYNGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAVANIC</medicinalproduct>
        <drugdosagetext>1-0-0</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>1-0-0</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>1-0-0</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>1-1-1</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAXIPARIN</medicinalproduct>
        <drugdosagetext>0-0-1</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132392-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-CELGENEUS-083-C5013-10112317</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CC-5013\PLACEBO</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132393-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-714621</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>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>B60063010, B6000B039, B6002B010, B+</drugbatchnumb>
        <drugdosagetext>FORM:INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100625</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>B60063010, B6000B039, B6002B010, B+</drugbatchnumb>
        <drugdosagetext>TEMPORARILY INTERRUPTED.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBAZAM</medicinalproduct>
        <drugdosagetext>10 MG AT 10 AM AND 30 MG AT 10 PM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIVALPROEX SODIUM</medicinalproduct>
        <drugdosagetext>500 MG AT 10 AM AND 750 MG AT 10 PM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAXSEED</medicinalproduct>
        <drugdosagetext>DRUG:FLAXSEED OIL</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA</medicinalproduct>
        <drugdosagetext>DRUG: OMEGA 3</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>AS PER THE REQUIREMENT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132394-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100421</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-717148</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132396-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100421</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-717158</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132397-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100420</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-717216</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132398-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-TEVA-236229ISR</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD KETONE BODY INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugauthorizationnumb>076420</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070830</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132399-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-ROCHE-719337</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>68.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILATREND</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZBROMARONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODIOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugdosagetext>DRUG REPORTED AS METHYLON</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOSARTAN</medicinalproduct>
        <drugdosagetext>OTHER INDICATION: PROTEINURIA</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100404</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132401-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NAPPMUNDI-GBR-2010-0007216</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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugauthorizationnumb>040086</drugauthorizationnumb>
        <drugdosagetext>400 MG, DAILY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN</medicinalproduct>
        <drugdosagetext>50 MG, DAILY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132402-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-722562</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19860301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132403-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-AVENTIS-2010SA070944</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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>016273</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERCIAN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGITALINE NATIVELLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINTROM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090905</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132404-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-722617</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THORACIC VERTEBRAL FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19891104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19900101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132405-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-722647</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>44.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL HERPES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080731</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132406-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033346</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>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132413-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-722755</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL HERPES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19920101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132414-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-TEVA-256893GER</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>HOSTILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugauthorizationnumb>087406</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIMENHYDRINATE (VOMEX A)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARCUMAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM (PANTOZOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMIZOLE SODIUM (NOVAMINSULFON)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL HYDROCHLORIDE (DOCITON)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132415-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-TEVA-255897GER</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>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugauthorizationnumb>070152</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugauthorizationnumb>070152</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100402</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugauthorizationnumb>070152</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100412</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIPERIDEN HYDROCHLORIDE TAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ALCOHOL WITHDRAWAL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100412</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100330</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100402</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100412</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132416-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-722778</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>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19900101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132417-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-735800</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>110</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugbatchnumb>RJ1198</drugbatchnumb>
        <drugauthorizationnumb>017533</drugauthorizationnumb>
        <drugdosagetext>DOSE REPORTER AS: 2 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PARANOIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugdosagetext>DRUG REPORTED: VALTRIAN (LOSARTAN POTASSIUM)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PONDERA</medicinalproduct>
        <drugdosagetext>1 TAB A DAY IN MORNING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCTYL</medicinalproduct>
        <drugdosagetext>FREQUENCY: 1 PER DAY/ AFTER DEFECATION</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132418-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-738096</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>38</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100713</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100714</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZULFIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100707</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100612</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCALTROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100612</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGLAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPARA-CA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100612</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
        <drugdosagetext>FORM: TAPE DRUG: MOHRUS TAPE DOSAGE UNCERTAIN</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132419-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-428548</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOTRETINOIN</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132420-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-PFIZER INC-2010155468</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>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>25 MG, 1X/DAY NOCTE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY NOCTE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132421-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-PFIZER INC-2010153441</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>PUSTULAR PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OTREON</medicinalproduct>
        <drugauthorizationnumb>050675</drugauthorizationnumb>
        <drugdosagetext>200 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101023</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugdosagetext>100 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101023</drugenddate>
        <drugtreatmentduration>1027</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugdosagetext>200 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101023</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN  AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>160/12.5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132422-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-672624</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAIR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugdosagetext>FREQ: 5 AMPOULES/MONTH, MISSED ONE DOSE IN DECEMBER</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMYTRIL</medicinalproduct>
        <drugdosagetext>TAKEN WHEN PRESENTS PAIN</drugdosagetext>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRONE</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIMESULIDE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEFLAZACORT</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132423-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-SANOFI-AVENTIS-2010SA071572</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC RETINOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL DETACHMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIPEN</medicinalproduct>
        <drugbatchnumb>B268</drugbatchnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091231</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURAN T4</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132424-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-SANOFI-AVENTIS-2010SA072003</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>49</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMAGNESAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>HYPOPHARYNGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>HYPOPHARYNGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>HYPOPHARYNGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAVANIC</medicinalproduct>
        <drugdosagetext>1-0-0</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>1-0-0</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>1-0-0</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>1-1-1</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAXIPARIN</medicinalproduct>
        <drugdosagetext>0-0-1</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>2-2-2</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>1-1-1</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM VERLA TABLET</medicinalproduct>
        <drugdosagetext>1-1-1</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101031</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM-SANDOZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM-SANDOZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugdosagetext>1-0-1</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALINOR</medicinalproduct>
        <drugdosagetext>2-2-1</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM ASPARTATE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101109</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132425-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ENDO PHARMACEUTICALS INC.-OPIR20100044</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 DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPANA</medicinalproduct>
        <drugauthorizationnumb>021611</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPANA</medicinalproduct>
        <drugauthorizationnumb>021611</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPANA</medicinalproduct>
        <drugauthorizationnumb>021611</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPANA ER</medicinalproduct>
        <drugauthorizationnumb>021610</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN MANAGEMENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132426-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-680523</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>32</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CACHEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAFT DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE COLOUR ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NELFINAVIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
        <drugdosagetext>DRUG WITHDRAWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugdosagetext>DRUG WITHDRAWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CO-TRIMOXAZOLE</medicinalproduct>
        <drugdosagetext>DRUG WITHDRAWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KIVEXA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RALTEGRAVIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugdosagetext>DRUG WITHDRAWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132428-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-716710</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090327</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090422</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090527</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090722</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090819</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugdosagetext>FORM: PERORAL AGENT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URINORM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLAKAY</medicinalproduct>
        <drugdosagetext>FORM REPORTED: PERORAL AGENT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONIC ACID</medicinalproduct>
        <drugdosagetext>DRUG REPORTED AS FOSAMAC 35 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090624</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132429-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-AMGEN-AUSSP2010006250</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANTI-ERYTHROPOIETIN ANTIBODY NEGATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APLASIA PURE RED CELL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPREX</medicinalproduct>
        <drugdosagetext>UNK UNK, Q2WK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090130</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132430-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100420</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-717144</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132431-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-EISAI INC.-E2020-08009-SPO-JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS OBLITERANS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOREA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED SELF-CARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19750101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMODIAN-DEPOT</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19630101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMODIAN-DEPOT</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugauthorizationnumb>020690</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090601</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUP-4</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTERIOSCLEROSIS OBLITERANS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132432-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100421</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-717155</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132438-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100421</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-717218</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132439-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2008BH010999</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>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREATH SOUNDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC VALVE VEGETATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOCARDITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KLEBSIELLA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DELTASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE SODIUM SUCCINATE</medicinalproduct>
        <drugadministrationroute>065</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>2</drugcharacterization>
        <medicinalproduct>KAYEXALATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</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>7132440-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-722692</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAL FISSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19971201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132441-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-SANOFI-AVENTIS-2010SA071584</companynumb>
    <primarysource>
      <reportercountry>MEXICO</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 ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC FOOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020496</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132442-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-723030</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>BLOOD CHOLESTEROL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL DRYNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>STOP DATE REPORTED AS 31 SEP 98, LATER 80 MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYCLINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NUPRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFFERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARIJUANA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132443-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-EISAI INC.-E3810-04238-SPO-JP</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARIET (RABEPRAZOLE)</medicinalproduct>
        <drugauthorizationnumb>020973</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101017</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHINESE HERBAL MEDICINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101017</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132444-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-725577</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>32.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE BONE MARROW APLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL SENSORIMOTOR NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>B5004, B3343</drugbatchnumb>
        <drugdosagetext>FORM:7.5 MG/KG, LAST DOSE PRIOR TO SAE: 03 NOVEMBER 2010. TEMPORARILY INTERRUPTED</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACTINOMYCIN</medicinalproduct>
        <drugdosagetext>FORM:1.5 MG/M2, LAST DOSE:28 AUG 2010</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100828</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACTINOMYCIN</medicinalproduct>
        <drugdosagetext>LAST DOSE PRIOR TO SAE: 03 NOVEMBER 2010.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugdosagetext>FORM:60 MG/M2, LAST DOSE:29 AUG 2010</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100828</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugdosagetext>LAST DOSE PRIOR TO SAE : 04 NOVEMBER 2010.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugdosagetext>FORM:6 G/M2, LAST DOSE:29 AUG 2010</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100828</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugdosagetext>LAST DOSE PRIOR TO SAE:04 NOVEMBER 2010.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>LAST DOSE:28 AUG 2010, FORM:1.5 MG/M2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100903</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>RESTARTED. LAST DOSE PRIOR TO SAE : 17 SEPTEMBER 2010.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugdosagetext>REPORTED AS 800MGX3/W</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERFALGAN</medicinalproduct>
        <drugdosagetext>REPORTED AS 500MG*4/D</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100829</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPHREN</medicinalproduct>
        <drugdosagetext>REPORTED AS 8MG*2/D</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100902</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLITICAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100902</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPASFON</medicinalproduct>
        <drugdosagetext>DOSE:1-2AMP/D</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOLOSAL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRACUTIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CERNEVIT-12</medicinalproduct>
        <drugdosagetext>TDD:1.5 AMP /D</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUTESA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132445-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0633074-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>47.67</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132446-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-10P-062-0687823-00</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>104</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEMOTHERAPY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEMPLAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021606</drugauthorizationnumb>
        <drugdosagetext>ONCE PER WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPARATHYROIDISM SECONDARY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132447-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-725577</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>32.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE BONE MARROW APLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL SENSORIMOTOR NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>B5004, B3343</drugbatchnumb>
        <drugdosagetext>FORM:7.5 MG/KG, LAST DOSE PRIOR TO SAE: 03 NOVEMBER 2010. TEMPORARILY INTERRUPTED</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTINOMYCIN D</medicinalproduct>
        <drugdosagetext>FORM:1.5 MG/M2, LAST DOSE PRIOR TO SAE 03 NOV 2010</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100828</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugdosagetext>FORM:60 MG/M2, LAST DOSE PRIOR TO SAE 04 NOV 2010.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100828</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugdosagetext>FORM:6 G/M2, LAST DOSE PRIOR TO SAE 04 NOV 2010.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100828</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>LAST DOSE:28 AUG 2010, FORM:1.5 MG/M2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100903</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>RESTARTED. LAST DOSE PRIOR TO SAE : 17 SEPTEMBER 2010.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugdosagetext>REPORTED AS 800MGX3/W</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERFALGAN</medicinalproduct>
        <drugdosagetext>REPORTED AS 500MG*4/D</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100829</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPHREN</medicinalproduct>
        <drugdosagetext>REPORTED AS 8MG*2/D</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100902</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLITICAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100902</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPASFON</medicinalproduct>
        <drugdosagetext>DOSE:1-2AMP/D</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOLOSAL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRACUTIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CERNEVIT-12</medicinalproduct>
        <drugdosagetext>TDD:1.5 AMP /D</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUTESA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132449-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-727383</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>DIHYDROPYRIMIDINE DEHYDROGENASE DEFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugbatchnumb>118657 PLUS 130445</drugbatchnumb>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>DOSE PRIOR TO SAE:10 SEP 2010. DOSE ON DAY 1-33 W/O  WEEKENDS PLUS OPTIONAL BOOST. TREATMENT DELAYED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>LAST DOSE PRIOR TO SAE: 06 SEP 2010.  DOSE TO BE GIVEN ON DAY 1, 8, 15, 22 AND 29. TREATMENT DELAYED</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARDYFERON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANSILANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOLEVURE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132450-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-AVENTIS-2010SA071931</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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMAREL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020496</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100904</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAMOX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100904</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugdosagetext>10 MG AND 15 MG DAILY, EVERY TWO DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100904</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100904</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEMIGOXINE NATIVELLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100904</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEBIVOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132451-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2009BH012328</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>087125</drugbatchnumb>
        <drugadministrationroute>010</drugadministrationroute>
        <drugindication>HAEMODIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>107024</drugbatchnumb>
        <drugadministrationroute>010</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>010</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030427</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>107024</drugbatchnumb>
        <drugadministrationroute>010</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>010</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030430</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>010</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>107024</drugbatchnumb>
        <drugadministrationroute>010</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071229</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>107024</drugbatchnumb>
        <drugadministrationroute>010</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>107024</drugbatchnumb>
        <drugadministrationroute>010</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>107024</drugbatchnumb>
        <drugadministrationroute>010</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>107064</drugbatchnumb>
        <drugadministrationroute>010</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>107064</drugbatchnumb>
        <drugadministrationroute>010</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>107064</drugbatchnumb>
        <drugadministrationroute>010</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>087125</drugbatchnumb>
        <drugadministrationroute>010</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>107064</drugbatchnumb>
        <drugadministrationroute>010</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>107024</drugbatchnumb>
        <drugadministrationroute>010</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>107064</drugbatchnumb>
        <drugadministrationroute>010</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>107064</drugbatchnumb>
        <drugadministrationroute>010</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>404213</drugbatchnumb>
        <drugadministrationroute>010</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>404291</drugbatchnumb>
        <drugadministrationroute>010</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071031</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>402291</drugbatchnumb>
        <drugadministrationroute>010</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>404438</drugbatchnumb>
        <drugadministrationroute>010</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>402291</drugbatchnumb>
        <drugadministrationroute>010</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>402291</drugbatchnumb>
        <drugadministrationroute>010</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071218</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>402291</drugbatchnumb>
        <drugadministrationroute>010</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>402291</drugbatchnumb>
        <drugadministrationroute>010</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071222</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>402291</drugbatchnumb>
        <drugadministrationroute>010</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071224</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHOSLO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIATX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NPH INSULIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NPH INSULIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENSIPAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROPOIETIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080121</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132452-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EE-ROCHE-741158</companynumb>
    <primarysource>
      <reportercountry>ESTONIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELIRI</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100629</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132453-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-741161</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASTUZUMAB</medicinalproduct>
        <drugdosagetext>DOSE LEVEL: 6 MG/KG, FORM: VIAL, LAST DOSE PRIOR TO SAE 21 OCTOBER 2010</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASTUZUMAB</medicinalproduct>
        <drugdosagetext>TOTAL DOSE: 410 MG, DATE OF LAST DOSE PRIOR TO SAE: 11 NOVEMBER 2010</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>DOSE LEVEL: 15 MG/KG, FORM: VIAL, LAST DOSE PRIOR TO SAE 21 OCTOBER 2010</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>TOTAL DOSE: 1026 MG, DATE OF LAST DOSE PRIOR TO SAE: 11 NOVEMBER 2010</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>DOSE LEVEL: 6 AUC, FORM: VIAL, LAST DOSE PRIOR TO SAE 21 OCTOBER 2010</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>DOSE LEVEL: 6 AUC, DATE OF LAST DOSE PRIOR TO SAE: 11 NOVEMBER 2010</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>DOSE LEVEL: 75 MG/M2. FORM: VIAL, LAST DOSE PRIOR TO SAE 21 OCTOBER 2010</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>TOTAL DOSE: 135.25 MG, DATE OF LAST DOSE PRIOR TO SAE: 11 NOVEMBER 2010</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132454-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH000145</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>134</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ENZYMES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HISTIOCYTOSIS HAEMATOPHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNOSUPPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL FUNCTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY SYNCYTIAL VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STILL'S DISEASE ADULT ONSET</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC INFLAMMATORY RESPONSE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRACHEAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INTRAVENOUS CATHETER MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CATHETERISATION CARDIAC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HAEMODIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIZANIDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOSYN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <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>TYLENOL-500</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERRLECIT                               /USA/</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUONEB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENAZPRINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENTYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132459-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-BAXTER-2010BH028467</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FUNGAL PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132460-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-BAXTER-2010BH028681</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FUNGAL PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132461-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101121</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJCH-2010027308</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>90.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISTERINE WHITENING QUICK DISSOLVING STRIPS</medicinalproduct>
        <drugbatchnumb>3161610</drugbatchnumb>
        <drugdosagetext>TEXT:TWO STRIPS ONCE A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DENTAL CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>TEXT:20MG A DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugdosagetext>TEXT:120MG TWICE A DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>TEXT:ONE A DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132462-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AMGEN-DEUCT2010002223</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100412</drugenddate>
        <drugtreatmentduration>225</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>800 MG ONE TO THREE TIMES DAILY WHEN NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GYNODIAN-DEPOT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIANI</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTRAPHANE HM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132463-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-741639</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUZEON</medicinalproduct>
        <drugauthorizationnumb>021481</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132464-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-741838</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOTRETINOIN</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132465-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040625</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-741860</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOTRETINOIN</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132466-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060222</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-741922</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132470-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENZYME-FABR-1001680</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>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FABRAZYME</medicinalproduct>
        <drugdosagetext>70 MG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FABRY'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061218</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132471-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050819</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-742011</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL WALL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUZEON</medicinalproduct>
        <drugauthorizationnumb>021481</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132472-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXBR2010US02000</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugauthorizationnumb>090039</drugauthorizationnumb>
        <drugdosagetext>25 MG, QW</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>AUTOIMMUNE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>20 MG, BID</drugdosagetext>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325 MG, QD</drugdosagetext>
        <drugindication>ROUTINE HEALTH MAINTENANCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>15 MG, QD</drugdosagetext>
        <drugindication>AUTOIMMUNE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugdosagetext>ONCE WEEKLY</drugdosagetext>
        <drugindication>BONE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D3</medicinalproduct>
        <drugdosagetext>10000 U, QW</drugdosagetext>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>300 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>7.5 MG, QD</drugdosagetext>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132473-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2010DE12328</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA NERVOSA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN HEXAL (NGX)</medicinalproduct>
        <drugauthorizationnumb>075539</drugauthorizationnumb>
        <drugdosagetext>900 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>100 UG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROIDECTOMY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132474-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2010GB13029</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</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>ARTERIOSCLEROSIS CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JEJUNAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>60 MG/M2, TIW</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100319</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugauthorizationnumb>065339</drugauthorizationnumb>
        <drugdosagetext>50 MG/M2, TIW</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100319</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>1250 MG/M2, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>625 MG/M2, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100324</drugenddate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132475-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2010GB13190</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>ACUTE HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TROPONIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugauthorizationnumb>065209</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101109</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMETANIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCERYL TRINITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEBIVOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHOLCODINE LINCTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE W/SALMETEROL XINAFOATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIOTROPIUM BROMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132476-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2010US13178</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>CONTINUOUS HAEMODIAFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERDYNAMIC LEFT VENTRICLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLACTACIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugauthorizationnumb>075985</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132477-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US79398</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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENAZEPRIL HCL TABLETS (NGX)</medicinalproduct>
        <drugauthorizationnumb>076402</drugauthorizationnumb>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugindication>RENAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101105</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILK THISTLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GARLIC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101104</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132478-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2010US13124</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>CONSCIOUSNESS FLUCTUATING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugauthorizationnumb>078409</drugauthorizationnumb>
        <drugdosagetext>275 MG, BID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132479-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060907</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-742266</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLBLAINS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOTRETINOIN</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132480-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090924</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-742275</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>FORM: INFUSION</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLFOX REGIMEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132481-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-742283</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUZEON</medicinalproduct>
        <drugauthorizationnumb>021481</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132482-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IR-ROCHE-742749</companynumb>
    <primarysource>
      <reportercountry>IRAN (ISLAMIC REPUBLIC OF)</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>H1N1 INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OSELTAMIVIR</medicinalproduct>
        <drugauthorizationnumb>021087</drugauthorizationnumb>
        <drugdosagetext>TABLETS OR CAPSULES</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>H1N1 INFLUENZA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132483-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>TR-ROCHE-744186</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRCERA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARNITEN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEMIKS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132484-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-744460</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DRAINAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACLIZUMAB</medicinalproduct>
        <drugdosagetext>AT DAYS 4 AND 18 POST TRANSPLANT- AS PER PROTOCOL</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugdosagetext>20MG/KG/DOSE BD- DOSE AS PER PROTOCOL</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugdosagetext>0.20MG/KG WITHIN 6 HOURS OF TRANSPLANT--0.05MG/KG/DOSE X BD-DOSE AS PER PROTOCOL.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132485-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-739426</companynumb>
    <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 METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132486-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GENENTECH-310303</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090618</drugenddate>
        <drugtreatmentduration>157</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS NOS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132487-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-741304</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOTRETINOIN</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132492-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060522</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-741516</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>FUZEON</medicinalproduct>
        <drugauthorizationnumb>021481</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132493-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-741535</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>FUZEON</medicinalproduct>
        <drugauthorizationnumb>021481</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BURKITT'S LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132494-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13429BP</companynumb>
    <primarysource>
      <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>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132495-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-FF-00553FF</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOPLASTIC LEFT HEART SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100122</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132496-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13428BP</companynumb>
    <primarysource>
      <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>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101130</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132497-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20081008</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-742100</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>METASTASES TO CENTRAL NERVOUS SYSTEM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132498-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040217</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-742214</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIV INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUZEON</medicinalproduct>
        <drugauthorizationnumb>021481</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132499-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-AVENTIS-2010SA071316</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PYOSTACINE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100630</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>016273</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IXPRIM</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANIDIP</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132500-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-AMGEN-BRACT2010004128</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOFORMIN</medicinalproduct>
        <drugdosagetext>500 MG, 3X/DAY</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132501-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2010161698</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>
      <patientweight>68.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARGATROBAN</medicinalproduct>
        <drugauthorizationnumb>020883</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEPARIN-INDUCED THROMBOCYTOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101123</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAHOR</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101122</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101114</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERSYL</medicinalproduct>
        <drugdosagetext>5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101122</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101115</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAFALGAN</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101122</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugdosagetext>15 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101122</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugdosagetext>1 DF, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONTRAMAL</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101124</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132503-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-PFIZER INC-2009252937</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUNITINIB MALATE</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>25 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER EXTENSIVE STAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090630</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESALAZINE</medicinalproduct>
        <drugdosagetext>500 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>18 UG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugdosagetext>25/250 MICROG 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESPASMYL</medicinalproduct>
        <drugdosagetext>50 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>500 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081023</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINNARIZINE</medicinalproduct>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081023</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRADONAL</medicinalproduct>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132504-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007074594</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugauthorizationnumb>050711</drugauthorizationnumb>
        <drugdosagetext>250 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EYE INFECTION TOXOPLASMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070711</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEDERFOLINE</medicinalproduct>
        <drugdosagetext>25 MG, 3X/WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EYE INFECTION TOXOPLASMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100710</drugenddate>
        <drugtreatmentduration>1110</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MALOCIDE</medicinalproduct>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EYE INFECTION TOXOPLASMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070710</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132505-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-742315</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>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 1 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>DOSAGE IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>DOSAGE IS UNCERTAIN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugdosagetext>DOSAGE IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugdosagetext>DOSAGE IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>PEGINTRON(PEGINTERFERON ALFA-2B(GENETICAL RECOMBINATION). DOSAGE IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugtreatmentduration>53</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>DOSAGE IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugtreatmentduration>53</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132506-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-742392</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>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132507-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-742624</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOTRETINOIN</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132508-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-ROCHE-744169</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMIFLU</medicinalproduct>
        <drugauthorizationnumb>021087</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132509-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-744257</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOLOC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEMETIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132511-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-744415</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONTINUOUS HAEMODIAFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENIC NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACLIZUMAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>050758</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132512-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-744442</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACLIZUMAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugdosagetext>3 DAY COURSE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BASILIXIMAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132513-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-744767</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELPLAT</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090330</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>5-FU</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090330</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFOLINATE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090330</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCYRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMELTEON</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090330</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URIEF</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090403</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTROM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090425</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXART</medicinalproduct>
        <drugdosagetext>FREQUENCY: 1/</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090929</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132514-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10071581</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 HUMAN CHORIONIC GONADOTROPIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132515-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-AMGEN-ARGSP2010004563</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132516-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-744485</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACLIZUMAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>050759</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132517-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-744491</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACLIZUMAB</medicinalproduct>
        <drugdosagetext>AT DAYS 4 AND 18 POST TRANSPLANT- AS PER PROTOCOL</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugdosagetext>20MG/KG/DOSE BD- DOSE AS PER PROTOCOL</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugdosagetext>0.20MG/KG WITHIN 6 HOURS OF TRANSPLANT--0.05MG/KG/DOSE X BD-DOSE AS PER PROTOCOL</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugadministrationroute>037</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132518-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJCH-2010027303</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 EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132519-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ROCHE-744543</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</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>SIGMOIDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>AFTER FEW CYCLES THERAPY WAS DISCONTINUED.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>AFTER FEW CYCLES THERAPY WAS DISCONTINUED.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
        <drugdosagetext>AFTER FEW CYCLES THERAPY WAS DISCONTINUED.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugdosagetext>AFTER FEW CYCLES THERAPY WAS DISCONTINUED.</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132520-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-744556</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PERIPHERAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>FORM: INFUSION; STRENGTH: 25 MG/ML, RECEIVED 4 CYCLES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>5-FU</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132521-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-744669</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>LAST DOSE PRIOR TO SAE: 18 OCT 2010</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>LAST DOSE PRIOR TO SAE: 05 OCT 2010</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100828</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
        <drugdosagetext>LAST DOSE PRIOR TO SAE: 05 OCT 2010</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100828</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>5-FU</medicinalproduct>
        <drugdosagetext>LAST DOSE PRIOR TO SAE: 05 OCT 2010</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100828</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132522-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-744687</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugdosagetext>FORM: INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132523-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-744770</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALGANCICLOVIR HCL</medicinalproduct>
        <drugauthorizationnumb>021304</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CYTOMEGALOVIRUS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100805</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALGANCICLOVIR HCL</medicinalproduct>
        <drugauthorizationnumb>021304</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPRYCEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132531-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US80806</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080512</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132532-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP76407</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MECHANICAL VENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050574</drugauthorizationnumb>
        <drugdosagetext>150 MG, DAILY</drugdosagetext>
        <drugindication>NEPHROTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>40 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132533-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010DE16838</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALISKIREN</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>CODE NOT BROKEN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100502</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED ALISKIREN ALI+TAB</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>CODE NOT BROKEN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
        <drugtreatmentduration>183</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED NO TREATMENT RECEIVED NOMED</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>CODE NOT BROKEN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
        <drugtreatmentduration>183</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>CODE NOT BROKEN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
        <drugtreatmentduration>183</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED ALISKIREN ALI+TAB</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>NO TREATMENT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED NO TREATMENT RECEIVED NOMED</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>NO TREATMENT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>NO TREATMENT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>CODE NOT BROKEN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED NO TREATMENT RECEIVED NOMED</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>CODE NOT BROKEN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>CODE NOT BROKEN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESIDRIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DELIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOHEXAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AQUAPHOR TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132535-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2009JP45964</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>COLONIC STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ANTRAL VASCULAR ECTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL TELANGIECTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEOCOLOSTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LASER THERAPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMA CARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMATINIB</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMATINIB</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>300 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPER-CVAD</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132536-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010DE16241</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>120</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENURESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTRIGLYCERIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPOMATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugauthorizationnumb>020234</drugauthorizationnumb>
        <drugdosagetext>300 MG IN THE MORNING AND 600 MG IN THE EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100315</drugenddate>
        <drugtreatmentduration>5475</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugdosagetext>200MG, HALF TABLET IN THE MORNING AND HALF A TABLET IN THE EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132538-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US79710</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>KNEE OPERATION</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100618</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132539-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-ROCHE-744920</companynumb>
    <primarysource>
      <reportercountry>FINLAND</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>INTESTINAL FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACTEMRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132540-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-745046</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PARANEOPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132541-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CL-ROCHE-745073</companynumb>
    <primarysource>
      <reportercountry>CHILE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>PER 12 HOURS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132542-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010FR81229</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN URINE PRESENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNTOCINON</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100816</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOSE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100816</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132543-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US79413</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THYROID OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100521</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132544-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US79110</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>MEMORY IMPAIRMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132545-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010SE17808</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMN107 AMN+CAP</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>300 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090610</drugenddate>
        <drugtreatmentduration>546</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMN107 AMN+CAP</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090611</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132546-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA79487</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MAMMOPLASTY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4MG EVERY 6 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090419</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132547-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010AU79751</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIRUBIN CONJUGATED INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION ATRIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL STROMAL TUMOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOBULINS INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT ATRIAL DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR GRAFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG/DAY</drugdosagetext>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>600 MG/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>05 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugdosagetext>150 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugdosagetext>60 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132548-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2009US07521</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>ADNEXA UTERI MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADRENAL MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED INTEREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO SPINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIODONTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALPINGO-OOPHORECTOMY BILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCINEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132549-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US78851</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYFORTIC</medicinalproduct>
        <drugauthorizationnumb>050791</drugauthorizationnumb>
        <drugdosagetext>360 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132550-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CH79451</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugauthorizationnumb>010187</drugauthorizationnumb>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugindication>DYSTHYMIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MODURETIC 5-50</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>1 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEROTEC</medicinalproduct>
        <drugdosagetext>1 MG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132551-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US12894</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.633</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBARIC OXYGEN THERAPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR SPINE FLATTENING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL TURBINATE HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPEN WOUND</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENT DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEQUESTRECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SERRATIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER-AIRWAY COUGH SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUPRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYZAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugdosagetext>500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugdosagetext>0.4 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
        <drugdosagetext>500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORHEXIDINE GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTEREN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEREX (POLYSACCHARIDE-IRON COMPLEX)</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASACORT</medicinalproduct>
        <drugdosagetext>2 SPRAY EACH NOSTRIL</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHINOCORT</medicinalproduct>
        <drugdosagetext>1 SPRAY EACH NOSTRIL</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugdosagetext>1 DF, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPICILLIN</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASTELIN</medicinalproduct>
        <drugdosagetext>1 SPRAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLODERM</medicinalproduct>
        <drugdosagetext>APPLY TWICE DAILY</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTOPIC</medicinalproduct>
        <drugdosagetext>APPLY TWICE DAILY</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132552-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010IT74457</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENIGN BREAST NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE EROSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK LEFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CENTRAL NERVOUS SYSTEM NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPUTERISED TOMOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMANGIOMA OF LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGEAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO SPINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROENDOCRINE CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SARCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR INVASION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>200 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCLERODERMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101012</drugenddate>
        <drugtreatmentduration>140</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugdosagetext>4 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugdosagetext>125 MG X 2, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENAPREN</medicinalproduct>
        <drugdosagetext>5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASEXTEN</medicinalproduct>
        <drugdosagetext>20 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROPRAM</medicinalproduct>
        <drugdosagetext>20 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugdosagetext>10 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132553-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP80157</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONATE T29581+</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4MG (EVERY 3 TO 4 WEEKS)</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100323</drugenddate>
        <drugtreatmentduration>736</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRACYT</medicinalproduct>
        <drugdosagetext>2 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100902</drugenddate>
        <drugtreatmentduration>1172</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>8-HOUR BAYER</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090318</drugenddate>
        <drugtreatmentduration>639</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugdosagetext>0.2 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100902</drugenddate>
        <drugtreatmentduration>1001</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090318</drugenddate>
        <drugtreatmentduration>608</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090318</drugenddate>
        <drugtreatmentduration>468</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>3 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090318</drugenddate>
        <drugtreatmentduration>293</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM LACTATE</medicinalproduct>
        <drugdosagetext>3 G, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100902</drugenddate>
        <drugtreatmentduration>878</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASLON</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100902</drugenddate>
        <drugtreatmentduration>513</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAL</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100902</drugenddate>
        <drugtreatmentduration>520</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132554-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP80026</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>TOOTH FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132555-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010TW17179</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091015</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132556-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RS-SANOFI-AVENTIS-A01200909704</companynumb>
    <primarysource>
      <reportercountry>SERBIA</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>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INVESTIGATIONAL DRUG</medicinalproduct>
        <drugdosagetext>TREATMENT NUMBER: 0917047</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INVESTIGATIONAL DRUG</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CILAZAPRIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090210</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132557-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101100767</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>INFERTILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPERM COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132558-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-JNJFOC-20101108449</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREZISTA</medicinalproduct>
        <drugauthorizationnumb>021976</drugauthorizationnumb>
        <drugdosagetext>3 X 300 MG; GIVEN THAT THE 400 MG TABLET WAS TILL NOT AVAILABLE IN SPAIN.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132559-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-ROCHE-745180</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100923</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132560-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010NL76499</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugbatchnumb>S0230</drugbatchnumb>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4MG/5ML ONCE PER 21 DAYS</drugdosagetext>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100819</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugbatchnumb>S0240</drugbatchnumb>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4MG/5ML ONCE PER 21 DAYS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugbatchnumb>S0240</drugbatchnumb>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4MG/5ML ONCE PER 21 DAYS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101109</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132561-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010FR81434</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>ZOLEDRONATE T29581++BM</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132562-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2009DE10993</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENTEROCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KLEBSIELLA SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UROSEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DRAINAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugdosagetext>250 MG, DAILY DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYFORTIC</medicinalproduct>
        <drugdosagetext>1440 MG, DAILY DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NO TREATMENT RECEIVED NOMED</medicinalproduct>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132563-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CN64477</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AZOTAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROGENIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYMYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugauthorizationnumb>021014</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
        <drugtreatmentduration>549</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLOROQUINE PHOSPHATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DI QIAO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCALTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENEFITS BIOT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AIXI TE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAILING</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN 70/30</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132564-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2009AU10199</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CERTICAN</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>2 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090402</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132565-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP78208</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132567-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP47991</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</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>20100607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100611</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>20100623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100711</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM POLYSTYRENE SULFONATE</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
        <drugdosagetext>2 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMICRON</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELOKEN</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SORAFENIB TOSILATE</medicinalproduct>
        <drugdosagetext>800 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100304</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SORAFENIB TOSILATE</medicinalproduct>
        <drugdosagetext>400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTCILLIN</medicinalproduct>
        <drugdosagetext>4.0 G</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100614</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
        <drugdosagetext>1.0 G</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100616</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN PHOSPHATE</medicinalproduct>
        <drugdosagetext>1200 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100621</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIRSTCIN</medicinalproduct>
        <drugdosagetext>2.0 G</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100621</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugdosagetext>400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100628</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugdosagetext>0.25 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100706</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132568-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-745215</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132569-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-NOVOPROD-318825</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>98</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugbatchnumb>UNKOWN</drugbatchnumb>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132570-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-NOVOPROD-317914</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VICTIM OF HOMICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLIN 70/30</medicinalproduct>
        <drugauthorizationnumb>019991</drugauthorizationnumb>
        <drugindication>OFF LABEL USE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132571-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-318863</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>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>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>1.2 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>1.8 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132572-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-NOVOPROD-317903</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>HYPOGLYCAEMIC COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VICTIM OF CRIME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLIN 70/30</medicinalproduct>
        <drugauthorizationnumb>019991</drugauthorizationnumb>
        <drugindication>OFF LABEL USE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugdosagetext>0.012 G, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SCOPOLAMINE</medicinalproduct>
        <drugdosagetext>0.0005 G, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132573-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-NOVOPROD-303483</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIRAGLUTIDE FLEXPEN</medicinalproduct>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>1.8 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>1000 MG, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASTEN                             /00880402/</medicinalproduct>
        <drugdosagetext>20 UNK, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARDEGIC                           /00002703/</medicinalproduct>
        <drugdosagetext>75 UNK, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STILNOX                            /00914901/</medicinalproduct>
        <drugdosagetext>10 UNK, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132574-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-NOVOPROD-316659</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLIN N</medicinalproduct>
        <drugbatchnumb>YS60300</drugbatchnumb>
        <drugauthorizationnumb>019959</drugauthorizationnumb>
        <drugdosagetext>40 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100416</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLIN N</medicinalproduct>
        <drugauthorizationnumb>019959</drugauthorizationnumb>
        <drugdosagetext>20 U, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE DIPROPIONATE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VACCINES</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132575-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-NOVOPROD-317746</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>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONIC CLONIC MOVEMENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VICTIM OF CRIME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLIN 70/30</medicinalproduct>
        <drugauthorizationnumb>019991</drugauthorizationnumb>
        <drugindication>OFF LABEL USE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132576-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-NOVOPROD-306331</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYHYDRAMNIOS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE LABOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STILLBIRTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTRAPID HM PENFILL</medicinalproduct>
        <drugdosagetext>18 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100904</drugenddate>
        <drugtreatmentduration>173</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULATARD HM PENFILL</medicinalproduct>
        <drugauthorizationnumb>019959</drugauthorizationnumb>
        <drugdosagetext>6 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100904</drugenddate>
        <drugtreatmentduration>173</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132577-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070702</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-745324</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXANES</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132578-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-744463</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAFT DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>050723</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACLIZUMAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132579-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006413</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>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060120</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132580-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101012</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-NOVOPROD-317926</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD INSULIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VICTIM OF HOMICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIXTARD HUMAN 70/30</medicinalproduct>
        <drugauthorizationnumb>019991</drugauthorizationnumb>
        <drugindication>OFF LABEL USE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132581-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-NOVOPROD-314182</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugbatchnumb>N/A</drugbatchnumb>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>0.9 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100823</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>1 G, BID</drugdosagetext>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMICRON MR</medicinalproduct>
        <drugdosagetext>120 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132587-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006666</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19951221</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132588-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101108499</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>20-35 MG/M2 MIXED IN 100 CC 5 % DEXTROSE WATER OVER ONE HOUR ON ON DAY ONE.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO LIVER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugdosagetext>20-35 MG/M2 MIXED IN 100 CC 5 % DEXTROSE WATER OVER ONE HOUR ON ON DAY ONE.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>100-125 MG/M2 IN NORMAL SALINE 250 ML</drugdosagetext>
        <drugadministrationroute>013</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>100-125 MG/M2 IN NORMAL SALINE 250 ML</drugdosagetext>
        <drugadministrationroute>013</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugdosagetext>DAY 1</drugdosagetext>
        <drugadministrationroute>013</drugadministrationroute>
        <drugindication>METASTASES TO LIVER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugdosagetext>DAY 1</drugdosagetext>
        <drugadministrationroute>013</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>DAY 1 PRIOR TO CHEMOTHERAPY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO LIVER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>FOR 5 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>FOR 5 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>DAY 1 PRIOR TO CHEMOTHERAPY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132589-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101108498</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>20-35 MG/M2 MIXED IN 100 CC 5 % DEXTROSE WATER OVER ONE HOUR ON ON DAY ONE.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO LIVER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugdosagetext>20-35 MG/M2 MIXED IN 100 CC 5 % DEXTROSE WATER OVER ONE HOUR ON ON DAY ONE.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>100-125 MG/M2 IN NORMAL SALINE 250 ML</drugdosagetext>
        <drugadministrationroute>013</drugadministrationroute>
        <drugindication>METASTASES TO LIVER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>100-125 MG/M2 IN NORMAL SALINE 250 ML</drugdosagetext>
        <drugadministrationroute>013</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugdosagetext>DAY 1</drugdosagetext>
        <drugadministrationroute>013</drugadministrationroute>
        <drugindication>METASTASES TO LIVER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugdosagetext>DAY 1</drugdosagetext>
        <drugadministrationroute>013</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>DAY 1 PRIOR TO CHEMOTHERAPY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO LIVER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>FOR 5 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>FOR 5 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>DAY 1 PRIOR TO CHEMOTHERAPY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132590-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20100307161</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>0, 2, 6 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRAVOL TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132598-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-JNJFOC-20101108920</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCENTRATED MOTRIN INFANTS DROPS</medicinalproduct>
        <drugauthorizationnumb>020603</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCENTRATED MOTRIN INFANTS DROPS</medicinalproduct>
        <drugauthorizationnumb>020603</drugauthorizationnumb>
        <drugdosagetext>2 DAYS PER MONTH</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132599-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2010161240</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
        <drugauthorizationnumb>020987</drugauthorizationnumb>
        <drugdosagetext>20 TO 80 MG DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100817</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100829</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
        <drugdosagetext>40 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMERON</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>013</drugadministrationroute>
        <drugindication>ARTERIOGRAM CORONARY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100817</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132600-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2010161639</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</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>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>80 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORASPIN</medicinalproduct>
        <drugdosagetext>81 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>6 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132601-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-PFIZER INC-2010156428</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132602-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-HQWYE290807JUN04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>011839</drugauthorizationnumb>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>0.625/5MG</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19931101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19940601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>011839</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGESTERONE</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIEST</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIEST</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132603-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010156218</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>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>50 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STALEVO 100</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMANTADINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RASAGILINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132604-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010160761</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSIVE SYMPTOM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132605-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJCH-2010027300</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 EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRA-UTERINE DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132606-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MA-PFIZER INC-2010161515</companynumb>
    <primarysource>
      <reportercountry>MOROCCO</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMATIC CRISIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUINAPRIL HCL</medicinalproduct>
        <drugauthorizationnumb>019885</drugauthorizationnumb>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101130</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132607-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2009226536</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>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>011839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19931101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19940601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>011839</drugauthorizationnumb>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19931101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19940601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19931101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19940601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>0.625/5MG</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGESTERONE</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIEST</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132608-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2010155730</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL WEIGHT GAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY MASS INDEX INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>400 MG, UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugtreatmentduration>183</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132609-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2010160461</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URETHRAL ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>1 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVAMES</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132610-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010160763</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSIVE SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100918</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132611-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160623</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>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132617-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20101108284</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PALEXIA RETARD</medicinalproduct>
        <drugauthorizationnumb>022304</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132618-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101108120</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>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUCYNTA</medicinalproduct>
        <drugauthorizationnumb>022304</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE RELAXANT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132620-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-JNJFOC-20100304214</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE LABOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE RUPTURE OF MEMBRANES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREZISTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREZISTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREZISTA</medicinalproduct>
        <drugauthorizationnumb>021976</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RALTEGRAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RALTEGRAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RALTEGRAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132621-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20101104042</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZALDIAR</medicinalproduct>
        <drugauthorizationnumb>021123</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOOTHACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132622-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20090902539</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE MALFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
        <drugbatchnumb>0711781</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORDIAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECGONINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZOYLECGONINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132623-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101121</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101006225</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS CONTACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT ADHESION ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0908032;1008470P1</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0908032;1008470P1</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>NECK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132624-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101107650</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.18</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT ADHESION ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>1000868</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132625-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101107655</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.79</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE SCAB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTERED AT INAPPROPRIATE SITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION DURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT ADHESION ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
        <drugbatchnumb>1000862</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugindication>SWELLING</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132626-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20101104848</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>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020588</drugauthorizationnumb>
        <drugdosagetext>ONCE OR TWICE DAILY ON AN AS NEEDED BASIS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132627-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-JNJFOC-20101106464</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CUSHING'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COCAINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132628-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20101107882</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAZE PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABNORMAL BEHAVIOUR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEPTICUR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132629-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20101107626</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugauthorizationnumb>021346</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132630-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MY-JNJFOC-20080105967</companynumb>
    <primarysource>
      <reportercountry>MALAYSIA</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>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED ACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN STRIAE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>BRAIN INJURY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugauthorizationnumb>021346</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRAIN INJURY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLAZAPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132631-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2010SE56228</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>021399</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132632-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2010SE04124</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>PANCREATITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTORA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132633-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-AMGEN-AUSSP2010004535</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA OF EYELID</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>730</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132639-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VN-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-DE-06607GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CRYPTOCOCCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNE RECONSTITUTION SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PENICILLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTRIMOXAZOLE</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132640-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20100700828</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>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugdosagetext>CYCLE 1</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER RECURRENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ALANINE AMINOTRANSFERASE INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ASPARTATE AMINOTRANSFERASE INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER RECURRENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPSO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVARIAN CANCER RECURRENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVARIAN CANCER RECURRENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROHYPNOL</medicinalproduct>
        <drugdosagetext>TABLET, AS NECESSARY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132641-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101102081</companynumb>
    <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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ASCITES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXIL</medicinalproduct>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132642-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101107775</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>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXIL</medicinalproduct>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132644-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101100888</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>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>KIDNEY INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>020635</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132645-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20100602974</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>EPICONDYLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAVANIC</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132646-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-JNJFOC-20101107553</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOXACIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132647-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070604853</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE ROOT COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLANTAR FASCIITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENOSYNOVITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATITIS</drugindication>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132648-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20101200298</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ENTEROCOLITIS BACTERIAL</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELECOX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYSLEE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132649-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-EISAI INC.-E7389-01068-CLI-US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64</patientweight>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>E7389 (BOLD)</medicinalproduct>
        <drugauthorizationnumb>201532</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100623</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERLOTINIB HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100624</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132650-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2008BH010989</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>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAILURE TO THRIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID OVERLOAD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN CARDIAC DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071218</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071218</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</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>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINACALCET</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>LANTHANUM CARBONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOETIN ALFA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN LISPRO</medicinalproduct>
        <drugadministrationroute>065</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>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugadministrationroute>048</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>LANTUS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM A-D</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARINOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPINEPHRINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132651-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2008BH010992</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>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROMECHANICAL DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOTRACHEAL INTUBATION COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPLANT SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS IN DEVICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>010</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070922</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>010</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>010</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>010</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070922</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>010</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070918</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>010</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070922</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>010</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>THROMBOSIS IN DEVICE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PULMONARY EMBOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070516</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>PHOSLO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFUROXIME AXETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DECREASED APPETITE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENALTABS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL DECONGESTANT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASAL CONGESTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHERATUSSIN AC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</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>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070516</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENAZPRINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN UPPER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISORDIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070516</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070516</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPATITIS B VACCINE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEPHROCAPS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HECTOROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANCEF</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>HYDROMORPHONE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCAGEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUTOSE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORMAL SALINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132658-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-JNJFOC-20100908622</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>EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EROSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAKTARIN</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>017450</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAKTARIN</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>017450</drugauthorizationnumb>
        <drugdosagetext>QUANTITY SUFFICIENT, AD. US. EXT</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>TINEA PEDIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132659-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20101101841</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DISPENSING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugbatchnumb>35528;35538A</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugbatchnumb>35528;35538A</drugbatchnumb>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugbatchnumb>35528;35538A</drugbatchnumb>
        <drugdosagetext>1 X 50 MG MORNING AND 2 X 100 MG NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugbatchnumb>35528;35538A</drugbatchnumb>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INFLUENZA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOFRAMYCIN EAR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHOLESTEATOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132660-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-JNJFOC-20101107295</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugauthorizationnumb>021121</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132661-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101106045</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC BYPASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHORT-BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugauthorizationnumb>021121</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132662-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101108648</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>29.48</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLAT AFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATIONS, MIXED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugauthorizationnumb>021121</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132663-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ENDO PHARMACEUTICALS INC.-OPER20100208</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>RUPTURED CEREBRAL ANEURYSM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPANA ER</medicinalproduct>
        <drugauthorizationnumb>021610</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132666-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101108503</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>20-35 MG/M2 MIXED IN 100 CC 5 % DEXTROSE WATER OVER ONE HOUR ON ON DAY ONE.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO LIVER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugdosagetext>20-35 MG/M2 MIXED IN 100 CC 5 % DEXTROSE WATER OVER ONE HOUR ON ON DAY ONE.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>100-125 MG/M2 IN NORMAL SALINE 250 ML</drugdosagetext>
        <drugadministrationroute>013</drugadministrationroute>
        <drugindication>METASTASES TO LIVER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>100-125 MG/M2 IN NORMAL SALINE 250 ML</drugdosagetext>
        <drugadministrationroute>013</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugdosagetext>DAY 1</drugdosagetext>
        <drugadministrationroute>013</drugadministrationroute>
        <drugindication>METASTASES TO LIVER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugdosagetext>DAY 1</drugdosagetext>
        <drugadministrationroute>013</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>DAY 1 PRIOR TO CHEMOTHERAPY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO LIVER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>FOR 5 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>FOR 5 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>DAY 1 PRIOR TO CHEMOTHERAPY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132667-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101101024</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</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>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANCREAZE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022523</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANCREATIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132668-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20101102915</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUROTEP MT</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132669-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060906252</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>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>1-3 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugdosagetext>1-3 MG</drugdosagetext>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132670-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-JNJFOC-20101108185</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DROWNING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugauthorizationnumb>021346</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132672-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101108207</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>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAZADYNE</medicinalproduct>
        <drugauthorizationnumb>021169</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GALANTAMINE HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>021169</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APIXABAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APIXABAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANEXA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132676-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-BAXTER-2010BH028475</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FUNGAL PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132677-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101108805</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugdosagetext>ONCE DAILY SEASONALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132678-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-JNJFOC-20101108993</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>DOSE REPORTED AS ^3^</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSAID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132679-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ENDO PHARMACEUTICALS INC.-OPER20100206</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 ABUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPANA ER</medicinalproduct>
        <drugauthorizationnumb>021610</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132683-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010005912</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132685-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0660724-00</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>CHRONIC HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRRHOSIS ALCOHOLIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021402</drugauthorizationnumb>
        <drugdosagetext>75 MCG DAILY</drugdosagetext>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100509</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</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>OXYCODONE HCL</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>PROMETHAZINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132686-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ABBOTT-10P-114-0687826-00</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>160MG ON 11-SEP-2010, 80MG ON 25-SEP-2010, 40 MG EVERY 2 WEEKS FROM 12-OCT-2010 ONWARDS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100911</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132687-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ABBOTT-10P-150-0687690-00</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXAT</medicinalproduct>
        <drugdosagetext>2.5 STRENGTH</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132688-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SI-AMGEN-SVNNI2010005208</companynumb>
    <primarysource>
      <reportercountry>SLOVENIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CINACALCET HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>021688</drugauthorizationnumb>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPARATHYROIDISM SECONDARY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugdosagetext>80 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugdosagetext>UNK UNK, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCII CARBONAS</medicinalproduct>
        <drugdosagetext>1 G, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100912</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLURENORM</medicinalproduct>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
        <drugdosagetext>4 G, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOPURINOL</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOPRIL</medicinalproduct>
        <drugdosagetext>20 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORYOL</medicinalproduct>
        <drugdosagetext>25 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONTROLOC                          /01263201/</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
        <drugdosagetext>800 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TANYZ                              /01280301/</medicinalproduct>
        <drugdosagetext>400 A?G, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZEMPLAR</medicinalproduct>
        <drugdosagetext>1 A?G, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TONOCARDIN                         /00639301/</medicinalproduct>
        <drugdosagetext>4 UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101023</drugenddate>
        <drugtreatmentduration>211</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRO-DUR</medicinalproduct>
        <drugdosagetext>200 A?G, UNK</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DORMICUM                           /00036201/</medicinalproduct>
        <drugdosagetext>7500 A?G, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100612</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTILIN</medicinalproduct>
        <drugdosagetext>600 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100623</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORECORMON</medicinalproduct>
        <drugdosagetext>8000 IU, 2 TIMES/WK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZALDIAR                            /01573601/</medicinalproduct>
        <drugdosagetext>7500 A?G, INTERMITTENT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZALDIAR                            /01573601/</medicinalproduct>
        <drugdosagetext>3250 A?G, INTERMITTENT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132695-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RU-AMGEN-RUSSP2010001241</companynumb>
    <primarysource>
      <reportercountry>RUSSIAN FEDERATION</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugbatchnumb>1017519A</drugbatchnumb>
        <drugdosagetext>1</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
        <drugtreatmentduration>75</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugbatchnumb>1017519A</drugbatchnumb>
        <drugdosagetext>1 A?G/KG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugbatchnumb>1017519A</drugbatchnumb>
        <drugdosagetext>2 A?G/KG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugbatchnumb>1017519A</drugbatchnumb>
        <drugdosagetext>3 A?G/KG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNIZOLON</medicinalproduct>
        <drugdosagetext>170 MG, QD</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100929</drugenddate>
        <drugtreatmentduration>45</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNIZOLON</medicinalproduct>
        <drugdosagetext>120</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100929</drugenddate>
        <drugtreatmentduration>45</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THROMBOCONCENTRATE</medicinalproduct>
        <drugdosagetext>2</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100911</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRESH FROZEN PLASMA</medicinalproduct>
        <drugdosagetext>1</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100914</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUSPENSION OF ERITROCYTES FILTRATED</medicinalproduct>
        <drugdosagetext>1</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100914</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRASOL</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100914</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132696-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ABBOTT-10P-114-0687795-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYE INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAPULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN PLAQUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132697-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0688389-00</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>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020945</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARUNAVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091109</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132698-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ASTRAZENECA-2010SE55712</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA FACIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMAGNESAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>019810</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132705-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2010-41907</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100929</drugenddate>
        <drugtreatmentduration>236</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132706-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2010-41887</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA VIRAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugbatchnumb>DP026P0102</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101026</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTAVIS</medicinalproduct>
        <drugdosagetext>UNK UG, UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100813</drugenddate>
        <drugtreatmentduration>364</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CHANNEL BLOCKERS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132707-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2010-41484</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>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</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>7132708-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2010-41854</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugbatchnumb>EO072P0102</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132709-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101120</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2010-41899</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091030</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132710-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ACTELION-A-US2010-42005</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COR PULMONALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILOPROST INHALATION ROW</medicinalproduct>
        <drugdosagetext>UNK UG, 6 X DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100813</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132711-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101120</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2010-41929</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugbatchnumb>EP072P0102</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CHANNEL BLOCKERS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132712-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2010-41839</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugbatchnumb>EP072P0102</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTAVIS</medicinalproduct>
        <drugbatchnumb>01074A</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CHANNEL BLOCKERS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132713-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2010-40271</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</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>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
        <drugbatchnumb>94506B</drugbatchnumb>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090403</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132714-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2010-41391</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>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIGHT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>EP070P0103</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101104</drugenddate>
        <drugtreatmentduration>909</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CHANNEL BLOCKERS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132715-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2010-40965</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugbatchnumb>DP026P0102</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100927</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CHANNEL BLOCKERS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132716-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-SW-00370DB</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>38</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ONYCHOMADESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>1 ANZ</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugdosagetext>1 ANZ</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALEORID</medicinalproduct>
        <drugdosagetext>750 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERSYL NOVUM</medicinalproduct>
        <drugdosagetext>2.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugdosagetext>2 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELTROXIN</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132717-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-ACTELION-A-CH2010-41426</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132718-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2010-41856</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugbatchnumb>EP072P0102</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101026</drugenddate>
        <drugtreatmentduration>659</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132720-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ACTELION-A-CH2010-39574</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>REBOUND EFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIGHT VENTRICULAR SYSTOLIC PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 62.5 MG JPN</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
        <drugtreatmentduration>118</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 62.5 MG JPN</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060126</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 62.5 MG JPN</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>93.75 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060608</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 62.5 MG JPN</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 62.5 MG JPN</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>93.75 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060801</drugenddate>
        <drugtreatmentduration>39</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 62.5 MG JPN</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070802</drugenddate>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 62.5 MG JPN</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070818</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BERAPROST SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SARPOGRELATE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132727-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-10P-056-0653064-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</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>ENANTONE 11.25 MG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020708</drugauthorizationnumb>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100603</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUPRESSYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARDEGIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPENTUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PINAVERIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESIDRIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASTAREL</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>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IKOREL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</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>DIFFU K</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132728-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-10P-167-0687701-00</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>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132729-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-10P-062-0687801-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAL PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132730-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-10P-028-0685157-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BACTERIAL DISEASE CARRIER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>H1N1 INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <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>METHOTREXATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132736-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101108614</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <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>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132737-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2010158481</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYDROCHOLECYSTIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>DOSE ACCORDING TO PROTOCOL</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN</medicinalproduct>
        <drugdosagetext>0.4 MG, 1X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>5 MG, 1X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132738-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2008037098</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugauthorizationnumb>050670</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugdosagetext>EVERY DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>EVERY DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN TRIHYDRATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFPODOXIME PROXETIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071218</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132740-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-FR-WYE-H17544910</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INIPOMP</medicinalproduct>
        <drugauthorizationnumb>020988</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100710</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAZOCILLINE</medicinalproduct>
        <drugdosagetext>12 G, 1X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSEUDOMONAL BACTERAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100809</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugdosagetext>400 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100809</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>500 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSEUDOMONAL BACTERAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100808</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIKACIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100710</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132741-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101011</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-CELGENEUS-129-21880-10112320</companynumb>
    <primarysource>
      <reportercountry>POLAND</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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132742-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-CELGENEUS-129-21880-10112305</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>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132746-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201006007307</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>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugdosagetext>35 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100916</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132749-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101120</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101109020</companynumb>
    <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>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugdosagetext>REPORTED AS ^200 MG^</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STENT PLACEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugdosagetext>REPORTED AS ^200 MG^</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTERIAL GRAFT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132750-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010155189</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>004782</drugauthorizationnumb>
        <drugdosagetext>0.625 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD OESTROGEN ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>TENDONITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132751-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010157285</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL SENSATION IN EYE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYSTANE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>DRY EYE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELCHOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>12.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>2 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CITRATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MEDICAL DIET</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B3 (NICOTINIC ACID AMIDE)</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MEDICAL DIET</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MEDICAL DIET</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132752-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010156262</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.773</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>50 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101113</drugenddate>
        <drugtreatmentduration>75</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
        <drugdosagetext>10MG IN MORNING AND 20 MG AT NIGHT</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>50 MG, 2X/DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090913</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132753-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101121</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010153934</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.458</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030824</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132754-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010134157</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY SLEEP</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>20101019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101019</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugdosagetext>10 MG, DAILY</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>40 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugdosagetext>30 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>500 MG, DAILY</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugdosagetext>20 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>10 MG, DAILY</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugdosagetext>7.5 MG, AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132755-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010156648</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132756-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2009275567</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>011839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132757-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010156080</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>AMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugauthorizationnumb>012541</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132758-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010156184</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugindication>ANXIETY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>1000 MG, 1X/DAY</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132759-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010154476</companynumb>
    <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>ESTROPIPATE</medicinalproduct>
        <drugauthorizationnumb>083220</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132760-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010108288</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugauthorizationnumb>020334</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132761-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010155199</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENERGY INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132762-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010156303</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>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM SILVER</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COENZYME Q10</medicinalproduct>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AMNESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132763-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010155133</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>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugauthorizationnumb>020280</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132764-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101120</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010132096</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</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>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCINEX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PALIPERIDONE</medicinalproduct>
        <drugdosagetext>9 MG, 1X/DAY</drugdosagetext>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132765-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010123223</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugbatchnumb>V100645</drugbatchnumb>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132766-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010159579</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SEXUAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132767-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-US-WYE-H08315809</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>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>011839</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRATEST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132768-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010155051</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugbatchnumb>Z100483</drugbatchnumb>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugindication>BLOOD PRESSURE ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132769-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010154460</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>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugdosagetext>2400 MG, DAILY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132770-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-US-WYE-H18343310</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>020151</drugauthorizationnumb>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>020151</drugauthorizationnumb>
        <drugdosagetext>75 MG, 3X/DAY</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>020151</drugauthorizationnumb>
        <drugdosagetext>75 MG, 2X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugauthorizationnumb>020151</drugauthorizationnumb>
        <drugdosagetext>75 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAZOLAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132771-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010134765</companynumb>
    <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>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132772-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010155961</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>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugtreatmentduration>61</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132773-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010157309</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>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>100 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132774-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010154770</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>106</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY SLEEP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEXOFENADINE</medicinalproduct>
        <drugdosagetext>180 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SEASONAL ALLERGY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132775-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010153795</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132776-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010156896</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THYROTOXIC CRISIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugauthorizationnumb>018972</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132777-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010156855</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN FALSE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGEL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132778-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010153513</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.773</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF LIBIDO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132779-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010155512</companynumb>
    <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>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTROGEL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132780-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010126397</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>125</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>100 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132781-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010155985</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>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132782-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010094051</companynumb>
    <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>VIAGRA</medicinalproduct>
        <drugbatchnumb>314833021</drugbatchnumb>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132783-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010154865</companynumb>
    <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 DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL MYCOTIC INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRING</medicinalproduct>
        <drugauthorizationnumb>020472</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132784-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010155316</companynumb>
    <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>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132785-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010154955</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-TESTOSTERONE</medicinalproduct>
        <drugauthorizationnumb>085635</drugauthorizationnumb>
        <drugdosagetext>200 MG, EVERY 14 DAYS</drugdosagetext>
        <drugindication>BLOOD TESTOSTERONE DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-TESTOSTERONE</medicinalproduct>
        <drugauthorizationnumb>085635</drugauthorizationnumb>
        <drugdosagetext>100 MG, EVERY 14 DAYS</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132786-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010153665</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugdosagetext>UNK, 2X/DAY</drugdosagetext>
        <drugindication>DIABETIC NEUROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132787-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010156291</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>150 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>HYPOAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>PARAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugdosagetext>0.1 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>0.5 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>100 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION</medicinalproduct>
        <drugdosagetext>75 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
        <drugdosagetext>325 MG, AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>7.5 MG, 1X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132788-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-US-WYE-H18456910</companynumb>
    <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>PROTONIX</medicinalproduct>
        <drugauthorizationnumb>020987</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENALOG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132789-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010157772</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>UNINTENDED PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugauthorizationnumb>020246</drugauthorizationnumb>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132790-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010155107</companynumb>
    <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>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>50 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>100 MG, AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132791-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010153605</companynumb>
    <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>GENOTROPIN</medicinalproduct>
        <drugauthorizationnumb>020280</drugauthorizationnumb>
        <drugdosagetext>0.4 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HYPOPITUITARISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132792-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010153323</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugauthorizationnumb>012541</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>BLOOD OESTROGEN ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>600 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132793-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010159544</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>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020919</drugauthorizationnumb>
        <drugdosagetext>120 MG, DAILY</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132794-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010159459</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE DRYNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERACUSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLEOCIN</medicinalproduct>
        <drugauthorizationnumb>050441</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132795-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010122375</companynumb>
    <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>NEURONTIN</medicinalproduct>
        <drugbatchnumb>V100685</drugbatchnumb>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132796-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010157299</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>51.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DISPENSING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>50 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MOOD SWINGS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CADUET</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132797-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010155975</companynumb>
    <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>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AROMASIN</medicinalproduct>
        <drugauthorizationnumb>020753</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132798-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160737</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LACTOSE INTOLERANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132799-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010156292</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>96.145</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugdosagetext>320/25 MG, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>0.3 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132800-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010154271</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.32</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>50 MG, 2X/DAY</drugdosagetext>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugdosagetext>100 MG, 2X/DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>20 MG, AS NEEDED</drugdosagetext>
        <drugindication>OEDEMA PERIPHERAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>30 MG, AS NEEDED</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGENS</medicinalproduct>
        <drugdosagetext>1 MG, 1X/DAY</drugdosagetext>
        <drugindication>HORMONE THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132801-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2009279068</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>011839</drugauthorizationnumb>
        <drugdosagetext>2.5-10MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPHASE (PREMARIN;CYCRIN 14/14)</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132802-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101120</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010153745</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>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>150 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>MYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132803-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010123493</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.96</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY THROAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOCAL CORD DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOVIAZ</medicinalproduct>
        <drugauthorizationnumb>022030</drugauthorizationnumb>
        <drugdosagetext>4 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY INCONTINENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100927</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOVIAZ</medicinalproduct>
        <drugauthorizationnumb>022030</drugauthorizationnumb>
        <drugdosagetext>8 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101006</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>200 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>200 MG, 4X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
        <drugdosagetext>30 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIOTHYRONINE SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132804-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2009249525</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>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LYMPH NODES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>011839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>011839</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19981106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>0.625 MG, UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19981106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>0.625/2.5MG</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000815</drugenddate>
        <drugtreatmentduration>648</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTROGENS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHROID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000110</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132805-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-HQWYE804203FEB04</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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOMICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>020151</drugauthorizationnumb>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SOCIAL PHOBIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>020151</drugauthorizationnumb>
        <drugdosagetext>TITRATED UPT TO 300 MG DAILY OVER THE COURSE OF THREE WEEKS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugindication>SOCIAL PHOBIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000306</drugstartdate>
        <drugtreatmentduration>244</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
        <drugtreatmentduration>122</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132806-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010126178</companynumb>
    <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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, 3X/DAY</drugdosagetext>
        <drugindication>TINNITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugindication>LOSS OF LIBIDO</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYREM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132807-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010156035</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132808-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010152594</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
        <drugdosagetext>1 GTT, BOTH EYES, 1X/DAY</drugdosagetext>
        <drugindication>OPEN ANGLE GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132809-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-001-0945-M0200165</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NECK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugdosagetext>900 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EYE PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132810-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010154982</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLASHBACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>25 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132811-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-US-WYE-H17612510</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 EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugbatchnumb>E28338</drugbatchnumb>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>37.5 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugindication>PANIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>PANIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULOXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PSEUDOEPHEDRINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132812-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AMGEN-FRASP2010005243</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>CARBON MONOXIDE DIFFUSING CAPACITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>14447</drugbatchnumb>
        <drugdosagetext>25 MG, 2X/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>13593</drugbatchnumb>
        <drugdosagetext>25 MG, 2 TIMES PER 1 WK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050408</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050408</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050602</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOCIN</medicinalproduct>
        <drugdosagetext>1 TABLET 1 TIMES PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>5MG 1 TIMES PER 1 WK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132813-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010158559</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>96.599</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTION INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>100 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101126</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132814-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2009195990</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>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>011839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19941019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001128</drugenddate>
        <drugtreatmentduration>2233</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>011839</drugauthorizationnumb>
        <drugindication>MENOPAUSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19941019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001128</drugenddate>
        <drugtreatmentduration>2233</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>MENOPAUSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugindication>MENOPAUSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>011839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132815-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010153681</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101108</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132816-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010156959</companynumb>
    <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>AZITHROMYCIN</medicinalproduct>
        <drugauthorizationnumb>050710</drugauthorizationnumb>
        <drugdosagetext>HALF TEASPOON DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132817-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010152396</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>DIZZINESS</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>20101103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101104</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>200 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER BIPOLAR TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SCHIZOAFFECTIVE DISORDER BIPOLAR TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>30 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER BIPOLAR TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>0.5 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER BIPOLAR TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugdosagetext>25 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER BIPOLAR TYPE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132818-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010153650</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>50 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132819-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010153546</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AROMASIN</medicinalproduct>
        <drugauthorizationnumb>020753</drugauthorizationnumb>
        <drugdosagetext>25 MG, 1X/DAY</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>GASTROINTESTINAL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>FREQUENCY: EVERY 3 WEEKS,</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN K TAB</medicinalproduct>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132820-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010154645</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132821-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010154692</companynumb>
    <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 ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNINTENDED PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugauthorizationnumb>020246</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132822-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010135712</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</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>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101107</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>60 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MUSCLE RELAXANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
        <drugdosagetext>10/325 MG, AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugdosagetext>2 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENOPAUSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugdosagetext>100 MG, EVERY 72 HOURS</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMINEX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNISOM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132823-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010158453</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NOCTURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOVIAZ</medicinalproduct>
        <drugauthorizationnumb>022030</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLLAKIURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOVIAZ</medicinalproduct>
        <drugauthorizationnumb>022030</drugauthorizationnumb>
        <drugindication>HYPERTONIC BLADDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NERVOUSNESS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132824-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010153655</companynumb>
    <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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132825-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101121</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010153785</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66.667</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132827-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010157330</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75.283</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOVIAZ</medicinalproduct>
        <drugauthorizationnumb>022030</drugauthorizationnumb>
        <drugdosagetext>8 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLLAKIURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE</medicinalproduct>
        <drugdosagetext>25 UNK, 1X/DAY</drugdosagetext>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132829-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010154789</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132830-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-US-WYE-H18514410</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132831-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010155114</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>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOVIAZ</medicinalproduct>
        <drugauthorizationnumb>022030</drugauthorizationnumb>
        <drugdosagetext>4 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTONIC BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132832-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010151127</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>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>004782</drugauthorizationnumb>
        <drugdosagetext>1.25 MG, UNK</drugdosagetext>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132833-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010155546</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87.075</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT STORAGE OF DRUG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENOPAUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAREL</medicinalproduct>
        <drugbatchnumb>C091149</drugbatchnumb>
        <drugauthorizationnumb>019886</drugauthorizationnumb>
        <drugdosagetext>200 UG 3X/DAY</drugdosagetext>
        <drugindication>ENDOMETRIOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GUANFACINE</medicinalproduct>
        <drugdosagetext>0.75 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERGOCALCIFEROL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132834-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010159453</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTROL</medicinalproduct>
        <drugauthorizationnumb>020714</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132835-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010156395</companynumb>
    <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>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132836-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101027</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010145625</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>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugauthorizationnumb>018972</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DRONEDARONE</medicinalproduct>
        <drugdosagetext>400 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132837-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010157079</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>TARDIVE DYSKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132838-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010153619</companynumb>
    <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>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>084349</drugauthorizationnumb>
        <drugdosagetext>100 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19500101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132839-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010157286</companynumb>
    <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>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132840-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010156706</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>SEXUAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132841-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010148698</companynumb>
    <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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132842-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010156046</companynumb>
    <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>EXPIRED DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132843-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010159529</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MECLIZINE HCL</medicinalproduct>
        <drugauthorizationnumb>010721</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132844-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010155736</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>ELETRIPTAN HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>021016</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132845-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010152161</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132846-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010155080</companynumb>
    <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>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>25 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>125 MG, 1X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>150 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>200 MG, 2X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132847-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010108601</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>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>100 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugdosagetext>20 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132848-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010155627</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GROWTH OF EYELASHES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132849-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-HQWYE011319MAY04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>011839</drugauthorizationnumb>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19861202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>011839</drugauthorizationnumb>
        <drugdosagetext>5 MG,</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970327</drugenddate>
        <drugtreatmentduration>2257</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>0.625 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19871124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970327</drugenddate>
        <drugtreatmentduration>3412</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAVIL</medicinalproduct>
        <drugdosagetext>2-25 UNK</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860527</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAVIL</medicinalproduct>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132850-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010151178</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugauthorizationnumb>020246</drugauthorizationnumb>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132851-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010159377</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>ADVIL</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132852-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20101107756</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOMATISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugauthorizationnumb>021346</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132853-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BRISTOL-MYERS SQUIBB COMPANY-15376551</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugauthorizationnumb>009218</drugauthorizationnumb>
        <drugdosagetext>1 DF= 1 POSOLOGIC UNIT</drugdosagetext>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugdosagetext>100 U/ML AT THE DOSAGE OF 36 U</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
        <drugdosagetext>1DF=1 POSOLOGIC UNIT; 0.125 MG ORAL TABS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTRA</medicinalproduct>
        <drugdosagetext>20 MG MODIFIED RELEASE ORAL CAPS.1DF=1 POSOLOGIC UNIT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILATREND</medicinalproduct>
        <drugdosagetext>1DF=1,5 POSOLOGIC UNIT; 6.25 MG ORAL TABS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugdosagetext>1DF=22 POSOLOGIC UNITS; 30/70 100 U/ML</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132854-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-15284318</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugdosagetext>1 DF: 1 TAB RESTARTED ON 12-OCT-2010</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugdosagetext>1 DF: 1 TAB RESTARTED ON 12-OCT-2010</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100712</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132855-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RU-BRISTOL-MYERS SQUIBB COMPANY-15409253</companynumb>
    <primarysource>
      <reportercountry>RUSSIAN FEDERATION</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR VERTEBRAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUPUS NEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THORACIC VERTEBRAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABATACEPT</medicinalproduct>
        <drugdosagetext>OPEN: 04MAR10-18NOV2010(750MG);  BLINDED: 05MAR09-04FEB2010</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100304</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULPERAZON</medicinalproduct>
        <drugdosagetext>SULPERAZON # 10</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101114</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132856-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BRISTOL-MYERS SQUIBB COMPANY-15390412</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS EROSIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HELICOBACTER GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugauthorizationnumb>009218</drugauthorizationnumb>
        <drugdosagetext>1 DF:1 POSOLOGIC UNIT;</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASCRIPTIN</medicinalproduct>
        <drugdosagetext>1 DF:1 POSOLOGIC UNIT;</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYLORIC</medicinalproduct>
        <drugdosagetext>TABS;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENAPREN</medicinalproduct>
        <drugdosagetext>TABS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEACOR</medicinalproduct>
        <drugdosagetext>1 DF:1 POSOLOGIC UNIT.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugdosagetext>1 DF:2 POSOLOGIC UNITS 4MG TABS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
        <drugdosagetext>TABS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVONORM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132857-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BRISTOL-MYERS SQUIBB COMPANY-15411804</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENTECAVIR</medicinalproduct>
        <drugauthorizationnumb>021797</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132858-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AMGEN-DEUCT2010004601</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SHOULDER ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132859-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2010SE55753</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24295</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARTIA XT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132861-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13469BP</companynumb>
    <primarysource>
      <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>DRUG INEFFECTIVE</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>20101128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>FLUID RETENTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132862-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-10P-167-0687724-00</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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMYELINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132863-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-HQWYE029710MAR05</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>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132864-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-HQWYE981014JUL06</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>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>004782</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132865-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-US-WYE-H16739810</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>020216</drugauthorizationnumb>
        <drugdosagetext>0.625 MG/GRAM NIGHTLY</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>URINARY INCONTINENCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>020216</drugauthorizationnumb>
        <drugdosagetext>1.5 G 3 TIMES PER 1 WK</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132866-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010158541</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132867-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010159910</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.864</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IRON DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>020216</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>ATROPHIC VULVOVAGINITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132868-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-US-WYE-H18355410</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87.528</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100729</drugenddate>
        <drugtreatmentduration>247</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132869-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161204</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132870-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2008043609</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>42</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132871-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-US-WYE-H14269110</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>50 MG, 2X/DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS NOS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132872-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-US-WYE-H00747907</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>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>004782</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGESTIN-ED</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132873-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010083861</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
        <drugauthorizationnumb>019885</drugauthorizationnumb>
        <drugdosagetext>20 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>15 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>81 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugdosagetext>1 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>12.5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIURETIC THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132874-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160554</companynumb>
    <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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132875-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010120522</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>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090615</drugenddate>
        <drugtreatmentduration>389</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132876-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-HQWYE534728JUL04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020111</drugenddate>
        <drugtreatmentduration>473</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020309</drugenddate>
        <drugtreatmentduration>1125</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132877-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-US-WYE-H16891510</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>104</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL PM</medicinalproduct>
        <drugbatchnumb>E34500</drugbatchnumb>
        <drugauthorizationnumb>021394</drugauthorizationnumb>
        <drugdosagetext>1 CAPLET QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SITAGLIPTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132878-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-US-WYE-H18160210</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NIPPLE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>020216</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>1 MG, AS NEEDED</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132879-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-HQWYE126502JUN05</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020110</drugenddate>
        <drugtreatmentduration>2380</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132880-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-US-WYE-H18013710</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>004782</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132881-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-HQWYE347702APR04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960607</drugenddate>
        <drugtreatmentduration>45</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970306</drugenddate>
        <drugtreatmentduration>182</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980727</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991004</drugenddate>
        <drugtreatmentduration>164</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020412</drugenddate>
        <drugtreatmentduration>689</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980123</drugenddate>
        <drugtreatmentduration>2373</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HOT FLUSH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>NIGHT SWEATS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>MOOD SWINGS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>VULVOVAGINAL DRYNESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>VULVOVAGINAL PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19910729</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HOT FLUSH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>NIGHT SWEATS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19911112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19911213</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MOOD SWINGS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>VULVOVAGINAL DRYNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19920828</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>VULVOVAGINAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19921102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930331</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930623</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19930827</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19931015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19931223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940519</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19940927</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950131</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960805</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTROGENS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADERM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADERM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930331</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADERM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930623</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADERM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930820</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADERM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19931015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADERM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADERM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19940927</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADERM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19941129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADERM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950131</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADERM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
        <drugindication>HOT FLUSH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
        <drugindication>NIGHT SWEATS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
        <drugindication>MOOD SWINGS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
        <drugindication>VULVOVAGINAL DRYNESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
        <drugindication>VULVOVAGINAL PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132882-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-US-WYE-H16770510</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>67.12</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL PM</medicinalproduct>
        <drugbatchnumb>E34500</drugbatchnumb>
        <drugauthorizationnumb>021394</drugauthorizationnumb>
        <drugdosagetext>1 CAPLET QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100802</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132883-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2006152068</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>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNASYN</medicinalproduct>
        <drugauthorizationnumb>050608</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132884-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010148454</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</patientweight>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugbatchnumb>E55811</drugbatchnumb>
        <drugauthorizationnumb>020402</drugauthorizationnumb>
        <drugdosagetext>1 DF, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132885-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010134082</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SEXUAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugdosagetext>240 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132886-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-US-WYE-H17223410</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACROCHORDON</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HYPERPIGMENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>020216</drugauthorizationnumb>
        <drugdosagetext>THREE TIMES A WEEK</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>SEXUAL DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100820</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VULVOVAGINAL DRYNESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132887-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-HQWYE690611OCT04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugindication>PANIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132888-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-HQWYE246620JUL04</companynumb>
    <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>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OGEN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132889-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-US-WYE-H18411010</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARITAL PROBLEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL PM</medicinalproduct>
        <drugbatchnumb>E49633</drugbatchnumb>
        <drugauthorizationnumb>021394</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132891-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100827</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-HQWYE245024SEP04</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>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132892-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010107159</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>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOMICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132893-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101127</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010158633</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.689</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AKATHISIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugdosagetext>20 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132894-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-HQWYE003724FEB06</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>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTROGEN NOS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132895-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010156923</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>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOBACCO USER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugbatchnumb>167981</drugbatchnumb>
        <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>1 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>1 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132896-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010159552</companynumb>
    <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>PAINFUL ERECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132897-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160943</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>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</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>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>1 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132898-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160791</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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</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>20101125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAM ER</medicinalproduct>
        <drugdosagetext>100 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAM ER</medicinalproduct>
        <drugindication>NERVOUS SYSTEM DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAM ER</medicinalproduct>
        <drugindication>SPINAL COMPRESSION FRACTURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132899-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-US-WYE-H17618710</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>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugauthorizationnumb>020987</drugauthorizationnumb>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugauthorizationnumb>020987</drugauthorizationnumb>
        <drugindication>HYPERCHLORHYDRIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132900-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-US-WYE-H18039110</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugindication>NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132901-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-US-WYE-H18271910</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>020216</drugauthorizationnumb>
        <drugdosagetext>1 DF, 1X/DAY</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>HOT FLUSH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100301</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>020216</drugauthorizationnumb>
        <drugdosagetext>1 DF, 3 TIMES PER 1 WK</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>020216</drugauthorizationnumb>
        <drugdosagetext>1 DF, WEEKLY</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPERIDINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132902-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010117323</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>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>STARTING PACK AND CONTINUING PACK</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>STARTING PACK AND CONTINUING PACK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090515</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132903-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-HQWYE445914JUN04</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>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRATAB</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTROPIPATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132904-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010159996</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>25 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN/NIACIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132905-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-US-WYE-H18326910</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>91.61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132906-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160471</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>100 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132907-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101127</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010158629</companynumb>
    <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>7132908-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-HQWYE445914JUN04</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>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRATAB</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTROPIPATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132909-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160095</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>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
        <drugauthorizationnumb>021110</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132910-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010159776</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>DRUG INEFFECTIVE</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>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>1 MG, 2X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugdosagetext>5/325 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugdosagetext>10/325 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</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>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132911-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010117293</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>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>CHANTIX STARTER AND CONTINUING MONTH PACK</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090401</drugenddate>
        <drugtreatmentduration>743</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HCL AND ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOCARBAMOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MUSCLE RELAXANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132912-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-US-WYE-H18097010</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.388</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALABSORPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL DRYNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>004782</drugauthorizationnumb>
        <drugdosagetext>1.25 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132913-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010158730</companynumb>
    <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>DEAFNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132914-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010159643</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</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>20101122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101122</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132915-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010115587</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.585</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARTHROTEC</medicinalproduct>
        <drugbatchnumb>C091233</drugbatchnumb>
        <drugauthorizationnumb>020607</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARTHROTEC</medicinalproduct>
        <drugauthorizationnumb>020607</drugauthorizationnumb>
        <drugindication>DYSMENORRHOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARTHROTEC</medicinalproduct>
        <drugauthorizationnumb>020607</drugauthorizationnumb>
        <drugindication>TOOTHACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONTELUKAST SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>0.25 MG, 2X/DAY, AS NEEDED</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>150 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132916-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-HQWYE230001SEP05</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>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>004782</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRATAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132917-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160882</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>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132918-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010153671</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>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHALAMO-PITUITARY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>020882</drugauthorizationnumb>
        <drugdosagetext>800 MG, 4X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>020882</drugauthorizationnumb>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132919-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101007</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-US-WYE-H18041910</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugbatchnumb>E67962</drugbatchnumb>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>0.625MG/2.5MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101007</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugindication>HOT FLUSH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugindication>IRRITABILITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132920-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-US-WYE-H13621510</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLUGGISHNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPHASE (PREMARIN;CYCRIN 14/14)</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>0.625 MG/5 MG(ONE DOSE ONLY)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100206</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132921-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-US-WYE-H18366310</companynumb>
    <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>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>REDUCED HER DOSE BY ALTERNATING BETWEEN 50MG ONE DAY AND 100MG THE FOLLOWING DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132922-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010128815</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugauthorizationnumb>018353</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100721</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132923-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010117309</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>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPHRENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>STARTER PACKS AND CONTINUING PACKS WITH REFILLS</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</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>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANTIBIOTIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</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>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHEGAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYPHENE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN AND CLAVULANATE POTASSIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRATEST H.S.</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHERACOL /USA/</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCTIVE COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>THYROID DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN SR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132924-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-US-WYE-H18417310</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>50 MG 2X DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132925-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010159936</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>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUNBURN</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>20101125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132926-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-HQWYE992312APR05</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADERM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132927-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010147097</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TORISEL</medicinalproduct>
        <drugauthorizationnumb>022088</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132928-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010117327</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>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOMICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE INJURIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>STARTING AND CONTINUING PACKS</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080425</drugenddate>
        <drugtreatmentduration>148</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132929-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-HQWYE859304MAR05</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>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTROGENS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132930-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160702</companynumb>
    <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>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugauthorizationnumb>012623</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132931-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010159668</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>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132932-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010159830</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>9.977</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugauthorizationnumb>050710</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101121</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132933-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-US-WYE-H18386810</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.633</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132934-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-JPNSP2010004531</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANOSMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132936-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AMGEN-DEUCT2010004103</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>TENDON SHEATH INCISION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091209</drugenddate>
        <drugtreatmentduration>93</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugdosagetext>25 MG, QWK</drugdosagetext>
        <drugindication>POLYARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugdosagetext>50 MG, WEEKLY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100723</drugenddate>
        <drugtreatmentduration>88</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101010</drugenddate>
        <drugtreatmentduration>57</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METEX</medicinalproduct>
        <drugdosagetext>15 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMIZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMIZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132937-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ELI_LILLY_AND_COMPANY-ES201011005045</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>930 MG, EVERY 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER STAGE III</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100828</drugenddate>
        <drugtreatmentduration>48</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>870 MG, EVERY 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>139.5 MG, EVERY 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER STAGE III</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100828</drugenddate>
        <drugtreatmentduration>48</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIATION</medicinalproduct>
        <drugdosagetext>2 GY, DAILY (1/D)</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER STAGE III</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100825</drugenddate>
        <drugtreatmentduration>45</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100823</drugenddate>
        <drugtreatmentduration>54</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132938-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE201011000127</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>
      <reaction>
        <reactionmeddrapt>KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>A691860A</drugbatchnumb>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>29.2 U, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132939-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ELI_LILLY_AND_COMPANY-CA201011005526</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>A759524A</drugbatchnumb>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132940-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201010005375</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>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRASUGREL HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100529</drugstartdate>
      </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>ATIVAN</medicinalproduct>
        <drugdosagetext>1.5 MG, 3/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>500 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>125 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAXSEED OIL</medicinalproduct>
        <drugdosagetext>1 OTHER, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugdosagetext>500 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugdosagetext>1 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugdosagetext>0.4 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugdosagetext>135 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132941-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ELI_LILLY_AND_COMPANY-IT201011004408</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>500 MG/M2, DAY 1 EVERY 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>75 MG/M2, 1 EVERY 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>7.5 MG/KG, DAY 1 EVERY 21 DAYS</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugindication>BONE PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE</medicinalproduct>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugindication>GASTRIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101011</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132942-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201003006114</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOLERANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ODYNOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>500 MG/M2, DAY 1 EVERY 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100218</drugenddate>
        <drugtreatmentduration>64</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>500 MG/M2, DAY 1 EVERY 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100311</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>6 AUC, DAY 1 EVERY 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100218</drugenddate>
        <drugtreatmentduration>64</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>15 MG/KG, DAY 1 EVERY 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100218</drugenddate>
        <drugtreatmentduration>64</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>15 MG/KG, DAY 1 EVERY 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100311</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>600 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091023</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>1000 UG, 9 WKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100326</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
        <drugdosagetext>800 MG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>1000 MG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091023</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091023</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugdosagetext>10 MG, AS NEEDED</drugdosagetext>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugdosagetext>6 MG, UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091218</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugdosagetext>150 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLOW-MAG</medicinalproduct>
        <drugdosagetext>UNK, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOMAGNESAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>4 MG/KG, 2/D</drugdosagetext>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091216</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132943-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GENENTECH-305538</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>675 MG, Q4W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100802</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>675 MG, Q4W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100817</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MITOXANTRONE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>14 MG, Q4W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100803</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MITOXANTRONE</medicinalproduct>
        <drugdosagetext>14 MG, Q4W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100818</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORAMBUCIL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100803</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORAMBUCIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100818</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>45 MG, Q4W</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100803</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>45 MG, Q4W</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100818</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUTHYROX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVODOPA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORMOTEROL FUMARATE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUMBROMID</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIOTROPIUM BROMIDE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IDEOS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101030</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132944-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-GENENTECH-309745</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>100</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASTOIDECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA PNEUMOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION PSEUDOMONAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>2 G, X2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100531</drugenddate>
        <drugtreatmentduration>480</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100721</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIATEC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERLIXIT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090721</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IDROXICLOROCHINA</medicinalproduct>
        <drugdosagetext>INDICATION: AR</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100721</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132946-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHNY2010GB00514</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>MULTIPLE DRUG OVERDOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>MULTIPLE DRUG OVERDOSE</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132947-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2010US11305</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAALOX ADV MAXIMUM STRENGTH ANTACID/ANTIGAS (NCH)</medicinalproduct>
        <drugbatchnumb>10075419</drugbatchnumb>
        <drugdosagetext>1 TSP, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100705</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132948-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2010US17497</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>104.31</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER SPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICTURITION URGENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVACID 24 HR</medicinalproduct>
        <drugauthorizationnumb>022327</drugauthorizationnumb>
        <drugdosagetext>15 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BARRETT'S OESOPHAGUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132949-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-TEVA-252655GER</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>
      <patientweight>84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM DIFFICILE COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugauthorizationnumb>018242</drugauthorizationnumb>
        <drugdosagetext>2X800 MG SULFAMETHOXAZOLE PLUS 2X160 MG TRIMETHOPRIM DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100618</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORASEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHIMAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTHYROIDISM</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIOTROPIUM BROMIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENPROCOUMON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132950-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-GB-WYE-G06569310</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>62.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOLOGY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REFACTO</medicinalproduct>
        <drugbatchnumb>E12016</drugbatchnumb>
        <drugdosagetext>3000 IU, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100811</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REFACTO</medicinalproduct>
        <drugbatchnumb>E40584</drugbatchnumb>
        <drugdosagetext>3000 IU, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100811</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABACAVIR SULFATE/LAMIVUDINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETODOLAC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICONAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IODINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132951-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2010142407</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>8.53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FACTOR VIII INHIBITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REFACTO</medicinalproduct>
        <drugbatchnumb>E31859</drugbatchnumb>
        <drugdosagetext>500 IU, 3X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FACTOR VIII DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101007</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REFACTO</medicinalproduct>
        <drugbatchnumb>E64350</drugbatchnumb>
        <drugdosagetext>250 IU, 3X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101010</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REFACTO</medicinalproduct>
        <drugbatchnumb>E64350</drugbatchnumb>
        <drugdosagetext>250 IU, 2X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101014</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REFACTO</medicinalproduct>
        <drugbatchnumb>E64350</drugbatchnumb>
        <drugdosagetext>250 IU, 1X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101015</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REFACTO</medicinalproduct>
        <drugdosagetext>UNKNOWN DOSE FOR FACTOR VIII RECOVERY TEST</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132952-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15193618</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMTRICITABINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANADO</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADCO-DOL</medicinalproduct>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM + VITAMIN D</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSCOPAN</medicinalproduct>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132953-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2010US18367</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>88.435</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEDRIN TENSION HEADACHE(NCH)</medicinalproduct>
        <drugbatchnumb>10091835</drugbatchnumb>
        <drugdosagetext>2 DF, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TENSION HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132954-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2010DE16166</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINELL TTS 20 (NCH)</medicinalproduct>
        <drugbatchnumb>32709</drugbatchnumb>
        <drugauthorizationnumb>020076</drugauthorizationnumb>
        <drugdosagetext>14 MG, QD</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132955-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2010US18364</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>74.376</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAALOX ADV MAXIMUM STRENGTH ANTACID/ANTIGAS (NCH)</medicinalproduct>
        <drugbatchnumb>10091039</drugbatchnumb>
        <drugdosagetext>UNK , UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101127</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132956-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10112378</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>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FULL BLOOD COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090602</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132957-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2008BH003604</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>74</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIAL SECRETION RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPENDENCE ON RESPIRATOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMBOLISM VENOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPARIN-INDUCED THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE INJURIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA STAPHYLOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>INTRAVENOUS CATHETER MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARGATROBAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080308</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENBREL</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>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULCOLAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</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>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132958-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2008BH010987</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSTRUCTIVE AIRWAYS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN CARDIAC DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEGENER'S GRANULOMATOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>HAEMODIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>INTRAVENOUS CATHETER MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>010</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>010</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>010</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>010</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>010</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>010</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>010</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>010</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugadministrationroute>010</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugadministrationroute>010</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugadministrationroute>010</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugadministrationroute>010</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugadministrationroute>010</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugadministrationroute>010</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugadministrationroute>010</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugadministrationroute>010</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHOSLO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEPHRO-VITE RX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDICAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <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>PROCARDIA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENAVITE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugadministrationroute>065</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>CALAN</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>MULTI-VITAMINS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYLANTA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132959-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2009BH018219</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>66</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CITROBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS ATROPHIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONEAL ADHESIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INTRAVENOUS CATHETER MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CATHETER PLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080131</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080131</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>7102784</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080311</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>7102804</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080311</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>8010064</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080311</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMEROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <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>AMBIEN</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>OXYCONTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIOTEK RX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORCET-HD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALINIA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS FUMARATE W/VITAMINS NOS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMEROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132960-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH001628</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>097016</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>HAEMODIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>097103</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>107066</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>087125</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>097081</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERSANTINE</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>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEPHROCAPS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPINEPHRINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORMAL SALINE</medicinalproduct>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>LOSS OF CONSCIOUSNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080118</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132961-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH002318</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY BYPASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID OVERLOAD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GANGRENE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPARIN-INDUCED THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIC-ISCHAEMIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE ABSENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>CATHETERISATION CARDIAC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>INTRA-AORTIC BALLOON PLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>CORONARY ARTERY BYPASS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>THROMBECTOMY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>VASCULAR GRAFT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INTRA-AORTIC BALLOON PLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <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>NASACORT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GERITOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORMAL SALINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</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>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUPIROCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISORDIL</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>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132962-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH006487</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BEDRIDDEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID OVERLOAD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPARIN-INDUCED THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBARACHNOID HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>STENT PLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>ANGIOPLASTY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>INTRAVENOUS CATHETER MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANGIOPLASTY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STENT PLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PULMONARY OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX ^CSL^</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARTIA XT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</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>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>2</drugcharacterization>
        <medicinalproduct>BISACODYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</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>HYDRALAZINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORHEXIDINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSIL-20</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <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>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN 70/30</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTROBAN NASAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIBICLENS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <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>AMLODIPINE BESILATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAALOX                                  /USA/</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132963-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10070997</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.088</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NATURAL KILLER-CELL LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100723</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERGOCALCIFEROL</medicinalproduct>
        <drugdosagetext>50,000 UNITS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090519</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>VITAMIN B12 DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORADOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASTEPRO</medicinalproduct>
        <drugdosagetext>1 SPRAY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE</medicinalproduct>
        <drugdosagetext>600</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100203</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132965-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10112875</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132966-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10100518</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>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME TRANSFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132967-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-257424USA</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>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULFATE AUTOHALER</medicinalproduct>
        <drugauthorizationnumb>021457</drugauthorizationnumb>
        <drugdosagetext>1-2 TIMES DAILY (2 PUFFS EACH USE) UP TO 3-4 TIMES DAILY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132968-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-MERCK-1011ESP00013</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>TIBIA FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132969-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1010USA01819</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COSOPT</medicinalproduct>
        <drugauthorizationnumb>020869</drugauthorizationnumb>
        <drugadministrationroute>047</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COSOPT</medicinalproduct>
        <drugbatchnumb>0939260</drugbatchnumb>
        <drugauthorizationnumb>020869</drugauthorizationnumb>
        <drugadministrationroute>047</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101014</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132970-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1011USA01280</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 ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132971-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0808USA02335</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>
      <patientweight>73</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACET JOINT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASTICATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEORADIONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY GLAND DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN FISSURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132972-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0810USA04871</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>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTINIC KERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRUXISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORNEAL ABRASION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCORIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED FASTING GLUCOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTATIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICULAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROSACEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVIAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPOROMANDIBULAR JOINT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHONDROITIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAXSEED</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132973-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0603USA00628</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>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDIX DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AZOTAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IRON DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL PROSTHESIS USER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURED SACRUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC POLYPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISIONAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL OSTEODYSTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROSACEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRAUMATIC HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOLVULUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHIPLASH INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050620</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061227</drugenddate>
        <drugtreatmentduration>2080</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100719</drugenddate>
        <drugtreatmentduration>1300</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100310</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100116</drugenddate>
        <drugtreatmentduration>159</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132974-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101021</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-1010USA02982</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>ENTEROCOLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100719</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100726</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100719</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELEGILINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100625</drugenddate>
        <drugtreatmentduration>128</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELEGILINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100626</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVODOPA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091229</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100719</drugenddate>
        <drugtreatmentduration>203</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTACAPONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100717</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132976-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-1011GBR00201</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>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>POLYARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMALIZUMAB</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132977-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1003USA03101</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>42</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL CANCER STAGE III</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AXILLARY MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS RADIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENITAL RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GROIN PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMANGIOMA OF LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE STRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DEFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132978-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0708USA00294</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>71</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALLERGY TO METALS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNS THIRD DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNE SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INADEQUATE DIET</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUPUS NEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOFASCIAL PAIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPEN WOUND</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSITIVITY OF TEETH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPOROMANDIBULAR JOINT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE DENSITY DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041203</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050501</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041203</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19770101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132979-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0706USA03756</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>
      <patientweight>84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA OF MALIGNANT DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY BYPASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTED NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL HERPES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR PERSONAL HYGIENE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN B12 DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
        <drugtreatmentduration>392</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132980-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0902USA00147</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>AORTIC ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENIGN BREAST NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST WALL MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESSENTIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROCYSTIC BREAST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATIC HEART DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL CORD COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPOROMANDIBULAR JOINT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICOSE VEIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031218</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031218</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132981-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-1011GBR00063</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>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISENTRESS</medicinalproduct>
        <drugauthorizationnumb>022145</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132982-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1011USA03227</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>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080201</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132983-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-MERCK-1011ESP00030</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLUENZA VIRUS SAG 3V VACCINE INACTIVATED</medicinalproduct>
        <drugbatchnumb>10-4802</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101005</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDACATEROL MALEATE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101006</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULFATE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>048</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>2</drugcharacterization>
        <medicinalproduct>MEBEVERINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALANINE AND GLUTAMIC ACID AND GLYCINE AND PYGEUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132985-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0906USA00694</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>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALVEOLAR OSTEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHANGE OF BOWEL HABIT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA PAROXYSMAL NOCTURNAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSTHYMIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EDENTULOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED TENDENCY TO BRUISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MAJOR DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASTICATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL TORUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPERATURE INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENOSYNOVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080201</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132986-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1011USA03547</companynumb>
    <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 CALCIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugauthorizationnumb>021687</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132987-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0903USA04196</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>ABSCESS JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APICAL GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDIX DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATROPHIC VULVOVAGINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DENSITY INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL PLAQUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOBAR PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAIL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMOCHROMIC NORMOCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL TORUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEORADIONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURITIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTOCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKELETAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENIC GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUTURE RELATED COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPOROMANDIBULAR JOINT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DEPOSIT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060801</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060801</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OGEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132989-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-1011USA00437</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>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID RPD</medicinalproduct>
        <drugauthorizationnumb>020752</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090430</drugenddate>
        <drugtreatmentduration>323</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090430</drugenddate>
        <drugtreatmentduration>323</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY EMBOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091008</drugenddate>
        <drugtreatmentduration>451</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090403</drugenddate>
        <drugtreatmentduration>296</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132990-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-1011USA03767</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>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101112</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGLAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXCEGRAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MENESIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RINDERON VG</medicinalproduct>
        <drugdosagetext>SPREADING SEVERAL TIMES A DAY</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSIDE (INDOMETHACIN)</medicinalproduct>
        <drugdosagetext>STICK ONCE A DAY</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOSENN</medicinalproduct>
        <drugdosagetext>BEFORE BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDES</medicinalproduct>
        <drugdosagetext>BEFORE BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRAMALIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLERMIST</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PA TABLETS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUFFERIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOBAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARDEPHYLLIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUITRAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID RPD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COSPANON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132991-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0812USA00484</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>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON ADENOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL PLAQUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC RETINOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPEN ANGLE GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION POSTOPERATIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>411</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN HUMAN, ISOPHANE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132992-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-1011USA01574</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132994-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0679431A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOMPHALOS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL DRUGS AFFECTING FOETUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugauthorizationnumb>020936</drugauthorizationnumb>
        <drugdosagetext>12.5MG PER DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN-D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132995-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0679433A</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>AORTIC STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BICUSPID AORTIC VALVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATENT DUCTUS ARTERIOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020936</drugauthorizationnumb>
        <drugdosagetext>40MG UNKNOWN</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132996-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0680345A</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>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE CONGENITAL ABNORMALITIES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugindication>ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugauthorizationnumb>020936</drugauthorizationnumb>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugindication>ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132997-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0680648A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSMORPHISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALLOT'S TETRALOGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL CYSTIC HYGROMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY VALVE STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugindication>ANXIETY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132998-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0681444A</companynumb>
    <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 SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOMALACIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLLAPSE OF LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugauthorizationnumb>020936</drugauthorizationnumb>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7132999-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0681483A</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>ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY OF INNER EAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL ATRESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRACHEO-OESOPHAGEAL FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VACTERL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133000-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693032A</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>
      <patientweight>122.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051231</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGULAR INSULIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVALIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133001-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0712512A</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>
      <patientweight>95.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070520</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STARLIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133002-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0722342A</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>
      <patientweight>71.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KERATOCONJUNCTIVITIS SICCA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR SURFACE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN AND CLAVULANATE POTASSIUM</medicinalproduct>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050329</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133003-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0731197A</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>118.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133004-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0743840A</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>
      <patientweight>86.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</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>20001227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133005-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0748173A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART DISEASE CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>40MG VARIABLE DOSE</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 3</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990421</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFZIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133006-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0765796A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>140.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</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>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133007-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0765800A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>150</patientweight>
      <patientsex>1</patientsex>
      <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 SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060904</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLENDIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVBID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133008-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0768556A</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>144.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070227</drugenddate>
        <drugtreatmentduration>769</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070424</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>135UNIT THREE TIMES PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMLIN</medicinalproduct>
        <drugdosagetext>20UNIT THREE TIMES PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133009-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0768751A</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>83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133010-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0770491A</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>
      <patientweight>113.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</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>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDARYL</medicinalproduct>
        <drugauthorizationnumb>021700</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM + MAGNESIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABETALOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIABETA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORMODYNE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133011-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0770494A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133012-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0797211A</companynumb>
    <primarysource>
      <reportercountry>PAKISTAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELTROMBOPAG</medicinalproduct>
        <drugauthorizationnumb>022291</drugauthorizationnumb>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOCYTOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090705</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELTROMBOPAG</medicinalproduct>
        <drugauthorizationnumb>022291</drugauthorizationnumb>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090715</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>180MCG WEEKLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090715</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugdosagetext>800MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090715</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133013-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0803564A</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>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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133014-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0803569A</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRAUMATIC LUNG INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060109</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133015-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0803842A</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>ARTERIAL OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</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>20000214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133016-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0832745A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>101.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133017-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0832751A</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133018-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0847402A</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>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugauthorizationnumb>020936</drugauthorizationnumb>
        <drugdosagetext>25MG UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060811</drugenddate>
        <drugtreatmentduration>59</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133019-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0847404A</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 EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATENT DUCTUS ARTERIOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133020-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0847405A</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>ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY VALVE STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSPOSITION OF THE GREAT VESSELS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133021-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0855970A</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>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOUS MEMBRANE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ONYCHOMADESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DEPIGMENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERMAL BURN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugbatchnumb>4ZP9821A</drugbatchnumb>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133022-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0873756A</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 ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PORTOPULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROMACTA</medicinalproduct>
        <drugauthorizationnumb>022291</drugauthorizationnumb>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100528</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
        <drugauthorizationnumb>020444</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133023-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0876415A</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>53.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL SOUNDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAIR COLOUR CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAIR TEXTURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOTRIENT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022465</drugauthorizationnumb>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugindication>LEIOMYOSARCOMA METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOOD</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133024-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0882089A</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>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
        <drugtreatmentduration>96</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QVAR 40</medicinalproduct>
        <drugauthorizationnumb>019389</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILK THISTLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133025-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0882826A</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>53.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugdosagetext>1000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>70MGM2 CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASTUZUMAB</medicinalproduct>
        <drugdosagetext>4MGK WEEKLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080530</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133026-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0883366A</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>
      <patientweight>82.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD MAGNESIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugdosagetext>1250MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INVESTIGATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100921</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133028-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0883827A</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugauthorizationnumb>020405</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APIXABAN</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLECAINIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133029-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0888164A</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133030-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0890722A</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND SECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYKERB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugdosagetext>1250MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101123</drugenddate>
        <drugtreatmentduration>319</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133031-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0890978A</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>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugbatchnumb>UNJKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090821</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133032-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0894066A</companynumb>
    <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>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133033-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0894067A</companynumb>
    <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>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133034-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0894068A</companynumb>
    <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>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133035-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0894069A</companynumb>
    <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>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133036-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0894070A</companynumb>
    <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>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133037-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0894071A</companynumb>
    <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>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133038-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0894232A</companynumb>
    <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>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133039-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0894233A</companynumb>
    <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>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133040-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0894246A</companynumb>
    <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>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133041-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0894247A</companynumb>
    <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>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133042-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0894248A</companynumb>
    <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>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133043-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0894249A</companynumb>
    <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>INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133044-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0894824A</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>DUTASTERIDE</medicinalproduct>
        <drugauthorizationnumb>021319</drugauthorizationnumb>
        <drugdosagetext>3.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080717</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100331</drugenddate>
        <drugtreatmentduration>623</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133045-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0896506A</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>56.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO CENTRAL NERVOUS SYSTEM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAZOPANIB</medicinalproduct>
        <drugauthorizationnumb>022465</drugauthorizationnumb>
        <drugdosagetext>800MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
        <drugdosagetext>5ML AS REQUIRED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>1CAP PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
        <drugdosagetext>235MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081027</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133046-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0896709A</companynumb>
    <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>SOCIAL AVOIDANT BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133047-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0896715A</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>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133048-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0896742A</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>CHOKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR</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>1</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugauthorizationnumb>020983</drugauthorizationnumb>
        <drugdosagetext>2PUFF PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133049-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897185A</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>ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COARCTATION OF THE AORTA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERY STENOSIS CONGENITAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugauthorizationnumb>020936</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133050-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897186A</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>CONGENITAL AORTIC ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBVALVULAR AORTIC STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN SR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990603</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VISTARIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990503</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELESTON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990503</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANCEF</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990503</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133051-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897187A</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 MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN SR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990603</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VISTARIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990503</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELESTON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990503</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANCEF</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990503</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133052-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897199A</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIPTANOL</medicinalproduct>
        <drugdosagetext>2TAB AT NIGHT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>1TAB AT NIGHT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RASILEZ</medicinalproduct>
        <drugdosagetext>.5TAB AT NIGHT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133053-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897208A</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>AEROLIN</medicinalproduct>
        <drugauthorizationnumb>018473</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133054-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897339A</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101124</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133055-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0510097A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRADURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>021345</drugauthorizationnumb>
        <drugdosagetext>7.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugdosagetext>.75UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAHOR</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HCL</medicinalproduct>
        <drugdosagetext>80MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERFALGAN</medicinalproduct>
        <drugdosagetext>4G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPASFON</medicinalproduct>
        <drugdosagetext>6INJ PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080218</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133056-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0551324A</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>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESKAZOLE</medicinalproduct>
        <drugauthorizationnumb>020666</drugauthorizationnumb>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133057-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0565041A</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELPHALAN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>014691</drugauthorizationnumb>
        <drugdosagetext>.2MGK PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>2MGK PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLORIC</medicinalproduct>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090203</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOW MOLECULAR WEIGHT HEPARIN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081230</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALACYCLOVIR HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>1G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090203</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugdosagetext>800MG TWO TIMES PER WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090203</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XATRAL</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS</medicinalproduct>
        <drugdosagetext>1IU PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRATION</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133058-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0637148A</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTOID REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugauthorizationnumb>018703</drugauthorizationnumb>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133059-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0638380A</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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE ABSENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugauthorizationnumb>018703</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133060-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0639379A</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>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugauthorizationnumb>020207</drugauthorizationnumb>
        <drugdosagetext>220MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091212</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VEPESID</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091211</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMERIN</medicinalproduct>
        <drugdosagetext>370MG PER DAY</drugdosagetext>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091207</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYLOCIDE</medicinalproduct>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091211</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUTROGIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091226</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUNGUARD</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091225</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091218</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091231</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUROTEP</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091221</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUROTEP</medicinalproduct>
        <drugdosagetext>4.2MG PER DAY</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091227</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUROTEP</medicinalproduct>
        <drugdosagetext>4.2MG PER DAY</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091230</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMITT</medicinalproduct>
        <drugdosagetext>990MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090626</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAL</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091029</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
        <drugdosagetext>500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091216</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugdosagetext>800MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091227</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091219</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXIPIME</medicinalproduct>
        <drugdosagetext>4G PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091218</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIENAM (IMIPENEME + CILASTATINE)</medicinalproduct>
        <drugdosagetext>1G PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091228</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>1.5G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091225</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100118</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133061-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0649619B</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugdosagetext>1500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100514</drugstartdate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASTUZUMAB</medicinalproduct>
        <drugdosagetext>2MGK WEEKLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100108</drugstartdate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>75MGM2 EVERY 3 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100108</drugstartdate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
        <drugdosagetext>1G AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>225G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133062-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0661481A</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>PULMONARY TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <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>20080730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100617</drugenddate>
        <drugtreatmentduration>98</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100617</drugenddate>
        <drugtreatmentduration>98</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133063-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0670743A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <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>20100805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100814</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugdosagetext>800MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100820</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133064-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0672915A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>111</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>021345</drugauthorizationnumb>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100806</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100807</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUVASTATIN</medicinalproduct>
        <drugdosagetext>80MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANIDIP</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133065-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0678896A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021345</drugauthorizationnumb>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133066-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0679651A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARTIAL SEIZURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100204</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugdosagetext>260MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBAZAM</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133067-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0680345A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL PERCENTAGE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE PERCENTAGE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL PERCENTAGE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAPULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIVASCULAR DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100726</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100802</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100917</drugenddate>
        <drugtreatmentduration>46</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugdosagetext>240MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRAIN NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100823</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXCEGRAN</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051025</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133068-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0680395A</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PROLACTIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugauthorizationnumb>022251</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMISULPRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100904</drugenddate>
        <drugtreatmentduration>3652</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133069-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0680764A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>021345</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100712</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100712</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERESTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EQUANIL</medicinalproduct>
        <drugdosagetext>2INJ PER DAY</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIATEC</medicinalproduct>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMAREL</medicinalproduct>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
        <drugdosagetext>1UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133070-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0681228A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KIVEXA</medicinalproduct>
        <drugbatchnumb>0987</drugbatchnumb>
        <drugauthorizationnumb>021652</drugauthorizationnumb>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100917</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugdosagetext>200MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100917</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARDEGIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOCTAMIDE</medicinalproduct>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051027</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133071-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0682084A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>51</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOPLEGIA</reactionmeddrapt>
      </reaction>
      <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>20100909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100930</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>1800MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100920</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100806</drugenddate>
        <drugtreatmentduration>65</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100806</drugenddate>
        <drugtreatmentduration>65</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100806</drugenddate>
        <drugtreatmentduration>65</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AROMASIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYSRON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100716</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINORELBINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI-DIARRHEAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133072-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0682101A</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>100</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPAFENONE HCL</medicinalproduct>
        <drugauthorizationnumb>019151</drugauthorizationnumb>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100527</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TELMISARTAN</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100527</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TELMISARTAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133073-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0683235A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHTHOUS STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIORBITAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EROSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101030</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101030</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPEN</medicinalproduct>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENET</medicinalproduct>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101030</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101030</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>7.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101030</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER D</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101030</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133074-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0683618A</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>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugauthorizationnumb>018603</drugauthorizationnumb>
        <drugdosagetext>1IUAX PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100404</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugauthorizationnumb>018603</drugauthorizationnumb>
        <drugdosagetext>2IUAX PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100405</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugauthorizationnumb>018603</drugauthorizationnumb>
        <drugdosagetext>3IUAX PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100408</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugauthorizationnumb>018603</drugauthorizationnumb>
        <drugdosagetext>2IUAX PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100412</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100419</drugenddate>
        <drugtreatmentduration>60</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VEGETAMIN A</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100421</drugenddate>
        <drugtreatmentduration>59</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WINTERMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100415</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100415</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYSLEE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100412</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENOBAL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100415</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100426</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133075-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0684349A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>132</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBODART</medicinalproduct>
        <drugauthorizationnumb>022460</drugauthorizationnumb>
        <drugdosagetext>1CAP PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101012</drugstartdate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugdosagetext>40MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-AMILOFRUSE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERSANTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-CODAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPOUND</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAMINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORACTEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133076-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0684413A</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLIXONASE</medicinalproduct>
        <drugauthorizationnumb>020548</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>RHINITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133077-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0684439A</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133078-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0684450A</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GLUCOSE URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIAGEN</medicinalproduct>
        <drugauthorizationnumb>020977</drugauthorizationnumb>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100707</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugauthorizationnumb>020564</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISENTRESS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100707</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133079-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0684470A</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GLUCOSE URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIAGEN</medicinalproduct>
        <drugauthorizationnumb>020977</drugauthorizationnumb>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100707</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugauthorizationnumb>020564</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISENTRESS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100707</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133080-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0684540A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAZOPANIB</medicinalproduct>
        <drugauthorizationnumb>022465</drugauthorizationnumb>
        <drugdosagetext>800MG PER DAY</drugdosagetext>
        <drugindication>DERMATOFIBROSARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100910</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133081-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0685527A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA TOTALIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MADAROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOPHREN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020007</drugauthorizationnumb>
        <drugdosagetext>8MG CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>178MG CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENDOXAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>920MG CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FARMORUBICINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>184MG CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>920MG CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHIMAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INIPOMP</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOCTAMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUPHALAC</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133082-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0685561A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021345</drugauthorizationnumb>
        <drugdosagetext>7.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101004</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>1G TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RESPIRATORY TRACT CONGESTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LERCANIDIPINE</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>50MCG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORLAX</medicinalproduct>
        <drugdosagetext>10G PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEMIGOXINE</medicinalproduct>
        <drugdosagetext>.125MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOCISTEIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RESPIRATORY TRACT CONGESTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101004</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133083-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0685870A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH SCARLATINIFORM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100920</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URBANYL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133084-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0686021A</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>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100615</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTHROTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060707</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133085-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0686077A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101108</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPLICONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101108</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133086-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0686094A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMOCHROMIC NORMOCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>021345</drugauthorizationnumb>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LERCANIDIPINE</medicinalproduct>
        <drugdosagetext>10MG IN THE MORNING</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETROL</medicinalproduct>
        <drugdosagetext>1UNIT IN THE MORNING</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133087-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0686500A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>10</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugdosagetext>1UNIT THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101114</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133088-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0686813A</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSLALIA</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>20101119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101123</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPARA-CA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLAKAY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT CC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOLAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133089-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0686917A</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARAVIROC</medicinalproduct>
        <drugauthorizationnumb>022128</drugauthorizationnumb>
        <drugdosagetext>300MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugauthorizationnumb>020857</drugauthorizationnumb>
        <drugdosagetext>450MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100505</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100505</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100505</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFIBRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETIMIBE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101002</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133090-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0686919A</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYBAN</medicinalproduct>
        <drugauthorizationnumb>020711</drugauthorizationnumb>
        <drugdosagetext>150MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100803</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133091-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0686959A</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>ABORTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>022251</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133092-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0686972A</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVAMYS</medicinalproduct>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133093-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0686976A</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION DURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN</medicinalproduct>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100805</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133094-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0686977A</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVAMYS</medicinalproduct>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133095-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0686979A</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>400MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA-3 TRIGLYCERIDES</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEROCCA C</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133096-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687049A</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MALARONE</medicinalproduct>
        <drugauthorizationnumb>021078</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MALARIA PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133097-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687089A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYKERB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugdosagetext>5IUAX PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133098-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687098A</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS TOXIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN</medicinalproduct>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugdosagetext>875MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133099-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687124A</companynumb>
    <primarysource>
      <reportercountry>POLAND</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>CD4 LYMPHOCYTES DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS CHORIORETINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RESISTANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNE RECONSTITUTION SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROTISING RETINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS FLOATERS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS OPACITIES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugauthorizationnumb>020564</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIAGEN</medicinalproduct>
        <drugauthorizationnumb>020977</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELZIR</medicinalproduct>
        <drugauthorizationnumb>021548</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIPRANAVIR + RITONAVIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUZEON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133100-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687128A</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD AMYLASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133101-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687131A</companynumb>
    <primarysource>
      <reportercountry>POLAND</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>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAPULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH VESICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN</medicinalproduct>
        <drugauthorizationnumb>050755</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133102-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>D0060132A</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SALBUHEXAL</medicinalproduct>
        <drugauthorizationnumb>020983</drugauthorizationnumb>
        <drugdosagetext>100MCG PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080830</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOL</medicinalproduct>
        <drugdosagetext>13.125G THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>50MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HCT</medicinalproduct>
        <drugdosagetext>12.5MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>15MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISCOVER</medicinalproduct>
        <drugdosagetext>75MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133103-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>Z0003878C</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OFATUMUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORAMBUCIL</medicinalproduct>
        <drugauthorizationnumb>010669</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100118</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133104-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>Z0006604B</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>54.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANAMIVIR</medicinalproduct>
        <drugauthorizationnumb>021036</drugauthorizationnumb>
        <drugdosagetext>600MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFLUENZA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133105-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>Z0006726A</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>100</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAZOPANIB</medicinalproduct>
        <drugauthorizationnumb>022465</drugauthorizationnumb>
        <drugdosagetext>800MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101118</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133106-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-257434USA</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>LICHEN PLANUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugauthorizationnumb>020622</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133107-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-EISAI INC.-E7389-01053-CLI-IT</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>E7389 (BOLD)</medicinalproduct>
        <drugauthorizationnumb>201532</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugadministrationroute>011</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACHIDOL</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLDESAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPORTIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLINGRAV</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-EFFERALGAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTOMALO SULPHATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LYMPHANGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101021</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101014</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIAZOL-PARACODINA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANEXAMIC ACID</medicinalproduct>
        <drugindication>HAEMOPTYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANEXAMIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOSTATIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARINA SODICA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOLO</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101021</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOROLAC TROMETHAMINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101021</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEXANE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORIDRATE SERTRALINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CALCIUM DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101007</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON HCL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101013</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101013</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLUVEN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>HYPOTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133109-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-SANOFI-AVENTIS-2010SA068572</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANEURYSM RUPTURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETROPERITONEAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATICA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM</medicinalproduct>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133111-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10111869</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>DEMENTIA ALZHEIMER'S TYPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133112-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHNY2010GB00517</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>OVERDOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133113-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHNY2010GB00519</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133114-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHNY2010GB00518</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>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133115-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHNY2010GB00515</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>OVERDOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133116-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHNY2010GB00516</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>MULTIPLE OVERDOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>MULTIPLE OVERDOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133117-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028772</companynumb>
    <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 INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133118-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10113197</companynumb>
    <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>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133119-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-SANOFI-AVENTIS-2010SA072411</companynumb>
    <primarysource>
      <reportercountry>MEXICO</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>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133120-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13369BP</companynumb>
    <primarysource>
      <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>SPIRIVA</medicinalproduct>
        <drugbatchnumb>909249A</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>909249A</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133121-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13303BP</companynumb>
    <primarysource>
      <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>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC 150</medicinalproduct>
        <drugbatchnumb>052072</drugbatchnumb>
        <drugauthorizationnumb>021698</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101125</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133122-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-12472NB</companynumb>
    <primarysource>
      <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>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BI-SIFROL TABLETS</medicinalproduct>
        <drugbatchnumb>NR</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>L-DOPA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133123-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROXANE LABORATORIES, INC.-2010-RO-01555RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>109</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BREATHING-RELATED SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugauthorizationnumb>022207</drugauthorizationnumb>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133124-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10113077</companynumb>
    <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>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133125-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GENZYME-THYR-1000430</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYROGEN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020898</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133130-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20101107484</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PROLACTIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALACTORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASTITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133134-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101107441</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.79</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZTROPINE MESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133135-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101108568</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>WEIGHT 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>7133136-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-JNJFOC-20101106848</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>1.47</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREZISTA</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREZISTA</medicinalproduct>
        <drugauthorizationnumb>021976</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RALTEGRAVIR</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133137-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20100907342</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>105.24</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OCULOGYRIC CRISIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugauthorizationnumb>021346</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133138-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-305023</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>101.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>834437</drugbatchnumb>
        <drugdosagetext>780 MG, Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133139-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-PFIZER INC-2010146230</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AFFECTIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OGEN</medicinalproduct>
        <drugauthorizationnumb>083220</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENORAL</medicinalproduct>
        <drugauthorizationnumb>083220</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133144-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101007079</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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133145-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201001001011</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 MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A591127C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100831</drugenddate>
        <drugtreatmentduration>302</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPEUTICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133146-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GENENTECH-310102</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>0.05 ML, UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133147-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-GENENTECH-289629</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>375 MG/M2, Q3W</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>750 MG/M2, Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133149-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-10P-087-0618956-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>40.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>ADVERSE DRUG REACTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFACALCIDOL</medicinalproduct>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugindication>PROTEIN URINE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090813</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL</medicinalproduct>
        <drugindication>PROTEIN URINE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090813</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM GUALENATE HYDRATE/L-GLUTAMINE</medicinalproduct>
        <drugindication>GASTROINTESTINAL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM GUALENATE HYDRATE/L-GLUTAMINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133150-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-BAXTER-2010BH028420</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133155-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2010158524</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</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>20100301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133156-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010157991</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
        <drugauthorizationnumb>021845</drugauthorizationnumb>
        <drugdosagetext>3 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DORNER</medicinalproduct>
        <drugdosagetext>3 UG/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133157-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028870</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>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DYE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133163-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028598</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>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY ASSOCIATED WITH DEVICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133164-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006621</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>
      <reaction>
        <reactionmeddrapt>IDIOPATHIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOPOIETIN LEVEL ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100830</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133165-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>Z0003878C</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OFATUMUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORAMBUCIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100118</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133166-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>Z0006281A</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>ESCHERICHIA BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090128</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OFATUMUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>15MG WEEKLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133169-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-12814BP</companynumb>
    <primarysource>
      <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>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>001646A,0D1002,UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>EMPHYSEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>001646A,0D1002,UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugdosagetext>25 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugdosagetext>2 PUF</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugindication>EMPHYSEMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133170-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-12872BP</companynumb>
    <primarysource>
      <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 150</medicinalproduct>
        <drugbatchnumb>A55161</drugbatchnumb>
        <drugauthorizationnumb>021698</drugauthorizationnumb>
        <drugdosagetext>450 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC 150</medicinalproduct>
        <drugbatchnumb>A55161</drugbatchnumb>
        <drugauthorizationnumb>021698</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR</medicinalproduct>
        <drugdosagetext>20 MEQ</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROPAN</medicinalproduct>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugindication>URINARY INCONTINENCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>1500 MG</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugdosagetext>50 MG</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>162 MG</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMEX</medicinalproduct>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugindication>FLUID RETENTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DLUCLOSAMIDE</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133171-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROXANE LABORATORIES, INC.-2010-RO-01556RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREATHING-RELATED SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugauthorizationnumb>022207</drugauthorizationnumb>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>SPINAL FUSION SURGERY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugauthorizationnumb>022207</drugauthorizationnumb>
        <drugindication>SPONDYLOLISTHESIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133172-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROXANE LABORATORIES, INC.-2010-RO-01557RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>113</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BREATHING-RELATED SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugauthorizationnumb>022207</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133173-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BAXTER-2010BH028591</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYOCET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133181-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2010047436</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD MAGNESIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECG SIGNS OF MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugauthorizationnumb>050670</drugauthorizationnumb>
        <drugdosagetext>500 MG, 3 TIMES WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100225</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugdosagetext>200 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPRAVENTRICULAR TACHYCARDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100225</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE</medicinalproduct>
        <drugdosagetext>2.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOCISTEINE</medicinalproduct>
        <drugdosagetext>750 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
        <drugdosagetext>20 MG, 2X/DAY</drugdosagetext>
        <drugindication>ANGINA PECTORIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133182-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2009230343</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>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>011839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>011839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OGEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRATAB</medicinalproduct>
        <drugdosagetext>0.625 MG, UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTROGENS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTROPIPATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ARTERIOSCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133183-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2010135062</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133184-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-US-WYE-H18190810</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>225 MG, UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>300 MG, 1X/DAY</drugdosagetext>
        <drugindication>SUICIDAL IDEATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>UNKNOWN DOSE</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>SUICIDAL IDEATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CILEST</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MENORRHAGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133186-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GENENTECH-310312</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>300 MG, Q2W</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090812</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>S0077B</drugbatchnumb>
        <drugdosagetext>300 MG, Q2W</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>S0077C</drugbatchnumb>
        <drugdosagetext>300 MG, Q2W</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091009</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>S0078</drugbatchnumb>
        <drugdosagetext>300 MG, Q2W</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091106</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133187-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PERRIGO-10US015046</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>22.676</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALO VISION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIAMCINOLONE ACETONIDE</medicinalproduct>
        <drugbatchnumb>0JT0079</drugbatchnumb>
        <drugauthorizationnumb>086414</drugauthorizationnumb>
        <drugdosagetext>A HANDFUL, THREE TIMES</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>URTICARIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIAMCINOLONE ACETONIDE</medicinalproduct>
        <drugbatchnumb>0JT0079</drugbatchnumb>
        <drugauthorizationnumb>086414</drugauthorizationnumb>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DRY SKIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EUCERIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>A HANDFUL, THREE TIMES</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>URTICARIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EUCERIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DRY SKIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133188-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PERRIGO-10GB015110</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>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>074661</drugauthorizationnumb>
        <drugdosagetext>250 MG, QID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101113</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101027</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK UG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIQUIFILM TEARS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>4 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133189-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PERRIGO-10GB015070</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>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>072096</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOOTH ABSCESS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133190-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PERRIGO-10US015036</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>31.746</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHILDREN'S IBUPROFEN</medicinalproduct>
        <drugbatchnumb>9FK0567</drugbatchnumb>
        <drugauthorizationnumb>074937</drugauthorizationnumb>
        <drugdosagetext>200 MG, SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALAISE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101117</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133195-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PERRIGO-10US015053</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>47.619</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION DURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYLEPHRINE HCL</medicinalproduct>
        <drugbatchnumb>0KK0347</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>NASAL CONGESTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYLEPHRINE HCL</medicinalproduct>
        <drugindication>NASAL DRYNESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIURETICS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EMPHYSEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIURETICS</medicinalproduct>
        <drugindication>SWELLING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133196-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENZYME-CLOF-1001296</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>14.966</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOLAR</medicinalproduct>
        <drugbatchnumb>09002480</drugbatchnumb>
        <drugauthorizationnumb>021673</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100912</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugdosagetext>60 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090612</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE</medicinalproduct>
        <drugdosagetext>0.068 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>20 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>75 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugdosagetext>150 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101008</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext>240 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>14.4 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTIGALL</medicinalproduct>
        <drugdosagetext>90 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGONATE</medicinalproduct>
        <drugdosagetext>2 ML, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101004</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133199-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2010143333</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</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>CARDIAC PROCEDURE COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>80 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133200-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-HQWYE803515OCT04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>0.625-2.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPHASE (PREMARIN;CYCRIN 14/14)</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133201-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2010157822</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</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>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>80 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133202-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010105135</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>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, (UID) 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100622</drugenddate>
        <drugtreatmentduration>161</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>8-HOUR BAYER</medicinalproduct>
        <drugdosagetext>100 MG, (UID) 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133203-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2010143379</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>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>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugindication>HYPERTRIGLYCERIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133204-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2010157574</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAHOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133205-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-HQWYE118226MAY04</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>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OESTROGEN REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPHASE (PREMARIN;CYCRIN 14/14)</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133206-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENZYME-FABR-1001684</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FABRAZYME</medicinalproduct>
        <drugbatchnumb>A0017A01, A0025A01</drugbatchnumb>
        <drugdosagetext>55 MG, Q2W</drugdosagetext>
        <drugindication>FABRY'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050725</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133211-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101108783</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>12.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROBIOTICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTRAN INJ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESALAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133213-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ELI_LILLY_AND_COMPANY-BR201010002158</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRASUGREL HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090926</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINVASTATINA</medicinalproduct>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAHISTINE</medicinalproduct>
        <drugindication>LABYRINTHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUSTRATE</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINA</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOGARD</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133214-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2010SE13926</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14475</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>88.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD CRAVING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GUN SHOT WOUND</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</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>
        <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>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133217-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101108921</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>71.22</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH TYLENOL</medicinalproduct>
        <drugbatchnumb>BEA280</drugbatchnumb>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH TYLENOL</medicinalproduct>
        <drugbatchnumb>BEA280</drugbatchnumb>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugdosagetext>REPORTED AS 1000MG ON 12-NOV-2010 AND 500MG ON 18-NOV-2010.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133218-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-EISAI INC.-E7389-01026-CLI-US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>E7389 (BOLD)</medicinalproduct>
        <drugauthorizationnumb>201532</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133219-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13468BP</companynumb>
    <primarysource>
      <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>CEREBROVASCULAR INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</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>7133220-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-12869BP</companynumb>
    <primarysource>
      <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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugbatchnumb>A30077</drugbatchnumb>
        <drugauthorizationnumb>021698</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133226-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101200806</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAILURE TO THRIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXIL</medicinalproduct>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BORTEZOMIB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133227-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20100706389</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57.61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INGUINAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugbatchnumb>09GMC098</drugbatchnumb>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugbatchnumb>09GMC098</drugbatchnumb>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugdosagetext>TAKES 2  IN AM AND 2 IN PM DAILY FOR YESRS; HER DOCTOR IS AWARE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI-HYPERTENSIVE</medicinalproduct>
        <drugdosagetext>UNKNOWN DOSE, TAKES DAILY  FOR YEARS</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL</medicinalproduct>
        <drugdosagetext>UNKNOWN DOSE, TAKES DAILY FOR YEARS</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI-CHOLESTEROL</medicinalproduct>
        <drugdosagetext>UNKNOWN DOSE, TAKES ONCE A DAY FOR YEARS</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>ONE AS NEEDED AT BEDTIME</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITRACAL</medicinalproduct>
        <drugdosagetext>ONCE A DAY FOR YEARS</drugdosagetext>
        <drugindication>NUTRITIONAL SUPPORT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133228-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-BAXTER-2010BH028673</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>TESTIS CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>B6030B01</drugbatchnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>TESTIS CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>B6133B01</drugbatchnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>TESTIS CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>TESTIS CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TESTIS CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TESTIS CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TESTIS CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133229-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006362</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>NPLATE</medicinalproduct>
        <drugdosagetext>10 A?G, UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101021</drugenddate>
        <drugtreatmentduration>183</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100520</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133230-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MK-SHIRE-SPV1-2010-02037</companynumb>
    <primarysource>
      <reportercountry>MACEDONIA, THE FORMER YUGOSLAV REPUBLIC OF</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IDURSULFASE</medicinalproduct>
        <drugdosagetext>0.5 MG/KG, UNK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>MUCOPOLYSACCHARIDOSIS II</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100512</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133232-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2010-37315</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>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133233-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2010-40690</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOVENOUS MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 125 MG US</medicinalproduct>
        <drugbatchnumb>EP070P0103</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100917</drugenddate>
        <drugtreatmentduration>423</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 125 MG US</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133234-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2010-42000</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>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080203</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133239-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RU-SANOFI-AVENTIS-2010SA070890</companynumb>
    <primarysource>
      <reportercountry>RUSSIAN FEDERATION</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID/MAGNESIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133240-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2010130445</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABILE BLOOD PRESSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CO-CODAMOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLYCERYL TRINITRATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020301</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020301</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020301</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANCURONIUM BROMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MUSCLE RELAXANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020301</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLIXONASE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133242-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2010-41265</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>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugbatchnumb>EP070P0103</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
        <drugtreatmentduration>661</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TREPROSTINIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133243-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU417871</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>1 A?G/KG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133244-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-AMGEN-KDC392484</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>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DENOSUMAB</medicinalproduct>
        <drugdosagetext>UNK UNK, QMO</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070602</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUVAX                             /00027001/</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080520</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugdosagetext>1.25 G, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN A</medicinalproduct>
        <drugdosagetext>300 IU, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE VALERATE</medicinalproduct>
        <drugdosagetext>UNK UNK, BID</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugdosagetext>10 ML, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090515</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133245-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL435859</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>6 MG, Q2WK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090327</drugenddate>
        <drugtreatmentduration>89</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugdosagetext>104 MG, QCYCLE</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090212</drugenddate>
        <drugtreatmentduration>46</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>1040 MG, QCYCLE</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090212</drugenddate>
        <drugtreatmentduration>46</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>294 MG, QCYCLE</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133246-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-AMGEN AB-KDC412088</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DENOSUMAB</medicinalproduct>
        <drugdosagetext>1.7 ML, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091202</drugenddate>
        <drugtreatmentduration>114</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AROMASIL</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133247-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-KDC427529</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANITUMUMAB</medicinalproduct>
        <drugdosagetext>510 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090423</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugdosagetext>480 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090423</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133248-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-GBRSP2010004401</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APLASIA PURE RED CELL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugdosagetext>80 A?G, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101108</drugenddate>
        <drugtreatmentduration>274</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLIC ACID</medicinalproduct>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101108</drugenddate>
        <drugtreatmentduration>490</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugdosagetext>5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100429</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100824</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CREON</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MALABSORPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090506</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133249-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-10P-056-0684370-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</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>NODULE ON EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133250-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0688515-00</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>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXOPLASMOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugindication>BLOOD TRIGLYCERIDES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN EYE DROPS</medicinalproduct>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN EYE DROPS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133251-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-10P-028-0685155-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56</patientweight>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE ABSENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugdosagetext>20 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>3 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <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>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133252-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-10P-020-0688574-00</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANKYLOSING SPONDYLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORRECTIVE LENS USER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGAMENT RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENISCUS LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>1 OR 2 PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHINITIS ALLERGIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>GASTRIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGISTRAL FORMULA</medicinalproduct>
        <drugdosagetext>KETOROLAC/TROMETAMOL 0.4% 4 DROPS/DAY</drugdosagetext>
        <drugindication>VISUAL IMPAIRMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133253-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-10P-028-0687599-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133254-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-10P-087-0676363-00</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>35</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UVEITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLARICID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATYPICAL MYCOBACTERIAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>KLARICID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugindication>BRONCHOPULMONARY ASPERGILLOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>RIFABUTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>MYCOBACTERIAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>RIFABUTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>BRONCHOPULMONARY ASPERGILLOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STREPTOMYCIN</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCYTOSINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETHAMBUTOL HYDROCHLORIDE</medicinalproduct>
        <drugindication>MYCOBACTERIAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133255-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-10P-087-0678991-00</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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020945</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090818</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAKTAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090818</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090818</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090818</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133256-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-ABBOTT-10P-066-0687786-00</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS PSORIASIFORM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MTX</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMICRON</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IDEOS</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BARAKLUD</medicinalproduct>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BARAKLUD</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133257-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-10P-087-0682123-00</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>
      <patientweight>41</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>0.5 TAB 1/DAY AT BREAKFAST</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugdosagetext>MA, AFTER MEALS</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFACALCIDOL</medicinalproduct>
        <drugdosagetext>AFTER BREAKFAST</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOCOPHERYL NICOTINATE</medicinalproduct>
        <drugdosagetext>AFTER EACH MEAL</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROTIZOLAM</medicinalproduct>
        <drugdosagetext>BEFORE SLEEP</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBAMIPIDE</medicinalproduct>
        <drugdosagetext>AFTER EACH MEAL</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTOMIN</medicinalproduct>
        <drugdosagetext>AFTER EACH MEAL</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHINESE HERBAL MEDICINE</medicinalproduct>
        <drugdosagetext>BEFORE EACH MEAL</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugdosagetext>AFTER EACH MEAL</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESALAZINE</medicinalproduct>
        <drugdosagetext>MA, AFTER MEALS</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALAZOSULFAPYRIDINE</medicinalproduct>
        <drugdosagetext>1 SUPPOSITORY DURING THE DAY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBETASOL PROPIONATE</medicinalproduct>
        <drugdosagetext>APPLIED TWICE A DAY ON THE SCALP</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXACALCITOL</medicinalproduct>
        <drugdosagetext>MIXED USING A 50G CUP AND APPLIED</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBETASOL PROPIONATE</medicinalproduct>
        <drugdosagetext>MIXED USING A 50G CUP AND APPLIED</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133258-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PR-ABBOTT-10P-131-0687094-00</companynumb>
    <primarysource>
      <reportercountry>PUERTO RICO</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.726</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LIPIDS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>325MG ONE HOUR PRIOR NIASPAN 500</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugdosagetext>30-40 UNITS DAILY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugdosagetext>40-40 UNITS DAILY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugdosagetext>100/12.5MG; 1 TABLET DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugdosagetext>50MG; 1 TABLET DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
        <drugdosagetext>2MG; 1 TABLET DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>75MG; 1 CAPSULE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>1 CAPSULE THREE TIMES DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETIC NEUROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75MG; 1 TABLET DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81MG; 1 TABLET DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>50MG; 1 TABLET DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133260-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006408</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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101026</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133261-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20100906887</companynumb>
    <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>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133265-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201006006835</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>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A713107C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133266-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201004007873</companynumb>
    <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 MAGNESIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A700601C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugdosagetext>UNK, EACH EVENING</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>1200 MG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugdosagetext>325 MG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>50000 U, WEEKLY (1/W)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40 MG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>5 MG, WEEKLY (1/W)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugdosagetext>40 MG, EACH EVENING</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARAFATE</medicinalproduct>
        <drugdosagetext>1 G, 3/D</drugdosagetext>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>UNK, 4/D</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRO/00003201/</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>UNK, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>50 UG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>150 MG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
        <drugdosagetext>25 MG, EACH MORNING</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugdosagetext>5 MG, 2/D</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugdosagetext>UNK, DAILY (1/D)</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133267-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA-2010-0046829</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>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE COMPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>40 MG, TID</drugdosagetext>
        <drugindication>BONE PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>40 MG, BID</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>45 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133268-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CEPHALON-2010006041</companynumb>
    <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>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVIGIL</medicinalproduct>
        <drugauthorizationnumb>021875</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVIGIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101029</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133273-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJCH-2010027180</companynumb>
    <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 BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISTERINE WHITENING QUICK DISSOLVING STRIPS</medicinalproduct>
        <drugdosagetext>TEXT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133277-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PURDUE-USA-2010-0055826</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXY INHALATION POWDER</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugindication>DRUG LEVEL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101126</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133278-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-NL-00450NL</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>150 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugdosagetext>150 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>150 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAXIPARINE</medicinalproduct>
        <drugdosagetext>9500 U</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROFUMARAAT</medicinalproduct>
        <drugdosagetext>600 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUCIDIN CREME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPROMELLOSE EYEDROPS</medicinalproduct>
        <drugdosagetext>EYE DROPS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugdosagetext>15 ML 3DD PRN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133279-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13352BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</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>SYMBICORT</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVENTIL</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133283-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CEPHALON-2010006190</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG PRESCRIBING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTORA</medicinalproduct>
        <drugauthorizationnumb>021947</drugauthorizationnumb>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>BRAIN NEOPLASM</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTORA</medicinalproduct>
        <drugauthorizationnumb>021947</drugauthorizationnumb>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>COMPLEX REGIONAL PAIN SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTEF</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DDAVP</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO TRI-CYCLEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BELLADONNA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALAGEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133287-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-JNJFOC-20100403490</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>017463</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>OLMETEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>EVEROLIMUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOCLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOLOC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYNORM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SEDATIVE THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133289-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011005224</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 1 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>021411</drugauthorizationnumb>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYVANSE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133290-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2008BH010977</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>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODYNAMIC INSTABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPEROSMOLAR STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX TRAUMATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>AORTIC VALVE REPLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HAEMODIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INTRAVENOUS CATHETER MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070407</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070407</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070407</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070224</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070224</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070224</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070306</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070306</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070306</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070308</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070308</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070308</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070309</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070309</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070309</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070312</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070312</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070312</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070314</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070314</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070314</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070316</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070316</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070316</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070319</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070319</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070319</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070320</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070320</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070320</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070309</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070309</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070309</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070408</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070408</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070408</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STARLIX</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>AZITHROMYCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHERATUSSIN COUGH SYRUP</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMPHENIR./DEXTROMETHOR./GUAIFENESIN/TERPIN/</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILRINONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOPRESSIN INJECTION</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOPHED</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOPHED</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEO-SYNEPHRINOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPINEPHRINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPINEPHRINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTAMINE SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUPIROCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MANNITOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYLEPHRINE HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANCEF</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133296-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-PFIZER INC-2010146589</companynumb>
    <primarysource>
      <reportercountry>GREECE</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>PIPERACILLIN AND TAZOBACTAM</medicinalproduct>
        <drugauthorizationnumb>050684</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAMIPEXOLE</medicinalproduct>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAMIPEXOLE</medicinalproduct>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMANTADINE HCL</medicinalproduct>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMANTADINE HCL</medicinalproduct>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUETIAPINE</medicinalproduct>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUETIAPINE</medicinalproduct>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVODOPA</medicinalproduct>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVODOPA</medicinalproduct>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBIDOPA</medicinalproduct>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBIDOPA</medicinalproduct>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIRACETAM</medicinalproduct>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIRACETAM</medicinalproduct>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROTIGOTINE</medicinalproduct>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROTIGOTINE</medicinalproduct>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133297-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-JP-WYE-H18020510</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>63</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOSYN</medicinalproduct>
        <drugauthorizationnumb>050684</drugauthorizationnumb>
        <drugdosagetext>4.5 G, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100725</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOSYN</medicinalproduct>
        <drugauthorizationnumb>050684</drugauthorizationnumb>
        <drugindication>PERITONITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugdosagetext>6 IU, DAY</drugdosagetext>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100717</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugdosagetext>1 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100722</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOFERMIN R</medicinalproduct>
        <drugdosagetext>3 TAB/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100724</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133298-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101121</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010059363</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 MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>50 MG, 3X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugdosagetext>7.5/500 MG TWICE DAILY AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND HYDROCODONE BITARTRATE</medicinalproduct>
        <drugdosagetext>7.5/500 EVERY 4-6 HOURS AS NEEDED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>200 MG, 3X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
        <drugdosagetext>20 MG, 3X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133299-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010155108</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>THYROID FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIZZINESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101121</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133300-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-US-WYE-H18013610</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>94.785</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA FACIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugdosagetext>250 MG, 2X/DAY</drugdosagetext>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133301-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010158599</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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</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>20080601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133302-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010159907</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugbatchnumb>0843020</drugbatchnumb>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>40 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIPEN</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133303-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HK-PFIZER INC-2010160860</companynumb>
    <primarysource>
      <reportercountry>HONG KONG</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOETTE</medicinalproduct>
        <drugauthorizationnumb>021864</drugauthorizationnumb>
        <drugdosagetext>1X/DAY, EVERYDAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOETTE</medicinalproduct>
        <drugauthorizationnumb>021864</drugauthorizationnumb>
        <drugindication>ENDOMETRIOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>EYE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133304-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-PFIZER INC-2010159180</companynumb>
    <primarysource>
      <reportercountry>GREECE</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133305-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010154929</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MALOCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugauthorizationnumb>020280</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133306-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2010147029</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>OVARIAN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133307-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010157282</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIKOSYN</medicinalproduct>
        <drugauthorizationnumb>020931</drugauthorizationnumb>
        <drugdosagetext>250 UG, 2X/DAY</drugdosagetext>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIKOSYN</medicinalproduct>
        <drugauthorizationnumb>020931</drugauthorizationnumb>
        <drugindication>HEART RATE IRREGULAR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CUMADIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133308-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2010158463</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>150 MG, 1X/DAY</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133309-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BAXTER-2010BH028961</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>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUPUS NEPHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUPUS NEPHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFACALCIDOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUPUS NEPHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISEDRONATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133310-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH029006</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>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULOXETINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133311-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2009BH007963</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>115</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLLAPSE OF LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID OVERLOAD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>097081</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080319</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>097081</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HAEMODIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080319</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>405122</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080319</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>405122</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080319</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080319</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080319</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080319</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080319</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080320</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080320</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080321</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080321</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSCAL</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>PHOSLO</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>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</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>FEXOFENADINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRGLYCERIN TRANSDERMAL SYSTEM</medicinalproduct>
        <drugadministrationroute>062</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>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMLA</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOPATCH</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTEMAX</medicinalproduct>
        <drugadministrationroute>047</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>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HECTOROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITE-AID FIBER CAPSULE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPHA LIPOIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMACOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLCYSTEINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTAZOCINE LACTATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILVADENE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROPOIETIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOBREX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INVANZ</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133316-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH029036</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>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAFCILLIN SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAFCILLIN SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPICILLIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133317-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2009BH014403</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>92</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL SEPTUM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>087125</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>097081</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>107024</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>107064</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>107074</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>087125</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>097081</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>107024</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>107064</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>107074</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070807</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070409</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070409</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESILATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABETALOL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENA-VITE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZEMPLAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080722</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080807</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHOSLO</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070802</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSRENOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080404</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMICIN SULFATE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080807</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070409</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070820</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENAPLEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENOFER</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080714</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITIZA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080201</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>REQUIP</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORMODYNE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOXIDIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
        <drugadministrationroute>065</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>VALSARTAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN EXPECTORANT W/ CODEINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SONATA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANDATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREGABALIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133318-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2009BH018167</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>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GANGRENE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODYNAMIC INSTABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPARIN-INDUCED THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SERRATIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>47092</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CATHETERISATION CARDIAC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>47092</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CORONARY ARTERY BYPASS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>47092</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>47092</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>47092</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>47092</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISACODYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERSED</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMEROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPINEPHRINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM HYDROXIDE</medicinalproduct>
        <drugadministrationroute>065</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>2</drugcharacterization>
        <medicinalproduct>DEXTROSE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTIVASE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133319-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH001841</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>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID OVERLOAD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HILAR LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMAGNESAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JUGULAR VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-SMALL CELL LUNG CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CENTRAL VENOUS CATHETERISATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INTRAVENOUS CATHETER MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>JUGULAR VEIN THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>VENOGRAM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071231</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071231</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071231</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071231</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071231</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071231</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071231</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071231</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071231</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071231</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071231</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071231</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNITS PER KILOGRAM</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>JUGULAR VEIN THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANASTROZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIACALCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <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>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORMAL SALINE</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>MAGNESIUM HYDROXIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE MALEATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE MAGNESIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITONIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GUAIFENESIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFUROXIME AXETIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER CHEMOTHERAPEUTICS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133324-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH011199</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>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080423</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133325-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NAPPMUNDI-USA_2009_0037292</companynumb>
    <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>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FORMICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCREAMING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>80 MG, SEE TEXT</drugdosagetext>
        <drugindication>DRUG ABUSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBUTEX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG ABUSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HYDROCHLORIDE (SIMILAR TO NDA 22-272)</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133326-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RU-PFIZER INC-2010158860</companynumb>
    <primarysource>
      <reportercountry>RUSSIAN FEDERATION</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>BREAST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL MUCOSAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOSTINEX</medicinalproduct>
        <drugauthorizationnumb>020664</drugauthorizationnumb>
        <drugdosagetext>0.25 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LACTATION INHIBITION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101124</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133327-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2010158229</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101010</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXOMIL</medicinalproduct>
        <drugdosagetext>180 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101010</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101010</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STABLON</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133328-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2010158941</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>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugauthorizationnumb>019949</drugauthorizationnumb>
        <drugdosagetext>150 MG, SINGLE</drugdosagetext>
        <drugindication>CANDIDIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CILEST</medicinalproduct>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOTRIMAZOLE</medicinalproduct>
        <drugdosagetext>1 DF, 1X/DAY</drugdosagetext>
        <drugindication>CANDIDIASIS</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133329-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2010158460</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>TONSILLAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOMATROPIN RDNA</medicinalproduct>
        <drugauthorizationnumb>020280</drugauthorizationnumb>
        <drugdosagetext>0.8 MG, 1X/DAY</drugdosagetext>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133330-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CEPHALON-2010006239</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>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVIGIL</medicinalproduct>
        <drugauthorizationnumb>021875</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CIRCADIAN RHYTHM SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugindication>DEPENDENCE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133331-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAXTER-2010BH026368</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>MARASMUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101004</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133332-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA-2010-0054311</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>CHEYNE-STOKES RESPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022272</drugauthorizationnumb>
        <drugdosagetext>60 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROAT CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022272</drugauthorizationnumb>
        <drugdosagetext>30 MG, QID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133338-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-WATSON-2010-15217</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>BLOOD COPPER INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORNEAL DEPOSITS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>090081</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugtreatmentduration>1825</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133339-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-WATSON-2010-15233</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>FOOD INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD POISONING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>080521</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TUBERCULIN TEST POSITIVE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133340-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-WATSON-2010-15230</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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOALDOSTERONISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN TABLETS</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>070436</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NONI JUICE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133341-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-WATSON-2010-15218</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>EXTRADURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN TABLETS</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>070436</drugauthorizationnumb>
        <drugdosagetext>800 MG, Q8H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AFTERBIRTH PAIN</drugindication>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIDOCAINE 1% W/ EPINEPHRINE 1:200,000</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugdosagetext>45 MG LIDOCAINE, 15 MICROGRAM EPINEPHRINE</drugdosagetext>
        <drugadministrationroute>008</drugadministrationroute>
        <drugindication>LOCAL ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133342-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-WATSON-2010-15214</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>DRUG SCREEN FALSE POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>080727</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASAL CONGESTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
        <drugauthorizationnumb>080727</drugauthorizationnumb>
        <drugindication>INSOMNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133343-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-WATSON-2010-15242</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</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>CENTRAL NERVOUS SYSTEM LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOTOXIC OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>063181</drugauthorizationnumb>
        <drugdosagetext>50 MG, DAILY</drugdosagetext>
        <drugindication>FOLLICULITIS</drugindication>
        <drugtreatmentduration>183</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133344-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-WATSON-2010-15211</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>99.773</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALCOHOL INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QRS COMPLEX PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPAFENONE HCL</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>075203</drugauthorizationnumb>
        <drugdosagetext>325 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPAFENONE HCL</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>075203</drugauthorizationnumb>
        <drugdosagetext>425 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL                            /00002101/</medicinalproduct>
        <drugdosagetext>8 BEERS AND 2 MIXED DRINKS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SOCIAL ALCOHOL DRINKER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133345-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-WATSON-2010-15462</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIC PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>065145</drugauthorizationnumb>
        <drugdosagetext>1 G, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG CONSOLIDATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPYREXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLAVULANATE POTASSIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPYREXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIPERACILLIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG CONSOLIDATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAZOBACTAM</medicinalproduct>
        <drugdosagetext>13 1/2 G, DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG CONSOLIDATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugdosagetext>750 MG, DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LEGIONELLA TEST POSITIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFAMPICIN</medicinalproduct>
        <drugdosagetext>900 MG, DAILY</drugdosagetext>
        <drugindication>PNEUMONIA LEGIONELLA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugdosagetext>800 MG, DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA LEGIONELLA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133346-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-WATSON-2010-15248</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>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugauthorizationnumb>077671</drugauthorizationnumb>
        <drugindication>POISONING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN SODIUM</medicinalproduct>
        <drugindication>POISONING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>POISONING</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133347-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006135</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>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1018632</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133348-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-BAXTER-2010BH020638</companynumb>
    <primarysource>
      <reportercountry>INDIA</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>PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>1005010</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100725</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>S10D05058</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100725</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133353-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA-2010-0048543</companynumb>
    <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>HERPES ZOSTER OPHTHALMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022272</drugauthorizationnumb>
        <drugdosagetext>80 MG, TID</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100912</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>022272</drugauthorizationnumb>
        <drugindication>BACK INJURY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133354-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2009269067</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>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>011839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>011839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTROGEN NOS</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CURRETAB</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AYGESTIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133355-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-GB-WYE-G06813410</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>
      <patientweight>62.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABILE BLOOD PRESSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DUODENAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CO-CODAMOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLYCERYL TRINITRATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANCURONIUM BROMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MUSCLE RELAXANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugdosagetext>1 DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020301</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLIXONASE</medicinalproduct>
        <drugdosagetext>1 UG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
        <drugindication>ANGINA PECTORIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133356-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-PFIZER INC-2010161569</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NELFINAVIR MESYLATE</medicinalproduct>
        <drugauthorizationnumb>020779</drugauthorizationnumb>
        <drugdosagetext>1250 MG, 1X/DAY</drugdosagetext>
        <drugindication>PROPHYLAXIS AGAINST HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugindication>PROPHYLAXIS AGAINST HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugdosagetext>450 MG, 1X/DAY</drugdosagetext>
        <drugindication>PROPHYLAXIS AGAINST HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133357-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2008067502</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCORIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIORBITAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133358-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010156103</companynumb>
    <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>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133359-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0684973-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOKALAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>20/12.5MG TWICE A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>20/12.5MG ONCE A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970626</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970716</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133360-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-10P-056-0677515-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>47.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021906</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMIK</medicinalproduct>
        <drugindication>HYPOTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEXAQUINE</medicinalproduct>
        <drugindication>MUSCLE SPASMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>HAEMORRHAGE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORLAX</medicinalproduct>
        <drugindication>GENERAL SYMPTOM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPASFON</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOMIL</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021013</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091127</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAAL</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081112</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133361-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-BAXTER-2010BH023092</companynumb>
    <primarysource>
      <reportercountry>INDIA</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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>1005010</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>S10D05058</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133362-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-12501BP</companynumb>
    <primarysource>
      <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>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133364-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13006BP</companynumb>
    <primarysource>
      <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>003421A</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>EMPHYSEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICATION NOT FURTHER SPECIFIED</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133365-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13375BP</companynumb>
    <primarysource>
      <qualification>5</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>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATROVENT HFA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021527</drugauthorizationnumb>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROVANA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133366-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13302BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugdosagetext>0.4 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATOMEGALY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133367-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2009-BP-14532BP</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>109</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE</medicinalproduct>
        <drugdosagetext>8 PUF</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE</medicinalproduct>
        <drugauthorizationnumb>020291</drugauthorizationnumb>
        <drugdosagetext>8 PUF</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugdosagetext>50 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA PERIPHERAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOPLUS MET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRA</medicinalproduct>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLOPIDINE BESFATE</medicinalproduct>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133368-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13009BP</companynumb>
    <primarysource>
      <qualification>2</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>001496A,9D1015</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101111</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133369-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-12874BP</companynumb>
    <primarysource>
      <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>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133370-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13007BP</companynumb>
    <primarysource>
      <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>003390A,0D1004</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugdosagetext>12.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133371-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-CS-01010CS</companynumb>
    <primarysource>
      <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>020850</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101126</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101126</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>ANTICOAGULATION DRUG LEVEL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133372-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-12955BP</companynumb>
    <primarysource>
      <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>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133373-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-12835BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugdosagetext>0.375 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022421</drugauthorizationnumb>
        <drugdosagetext>0.375 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLCYSTEINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>1000 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>2000 U</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONE A DAY MULTIVITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN ALLERGY INJECTION</medicinalproduct>
        <drugindication>MULTIPLE ALLERGIES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19700101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASTELIN NS</medicinalproduct>
        <drugdosagetext>274 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>MULTIPLE ALLERGIES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDODRINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>75 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133374-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-12680BP</companynumb>
    <primarysource>
      <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>TIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CATAPRES-TTS-1</medicinalproduct>
        <drugbatchnumb>0912401</drugbatchnumb>
        <drugauthorizationnumb>018891</drugauthorizationnumb>
        <drugdosagetext>0.2 MG</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>TIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugindication>TIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugindication>TIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugindication>TIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133375-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-12674BP</companynumb>
    <primarysource>
      <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>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOVIAZ</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133376-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2010-40519</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>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133377-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-CEPHALON-2010002285</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TREANDA</medicinalproduct>
        <drugauthorizationnumb>022249</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TREANDA</medicinalproduct>
        <drugauthorizationnumb>022249</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090309</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TREANDA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090309</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133378-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028665</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>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133383-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10113012</companynumb>
    <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>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133384-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GENENTECH-310295</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060709</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070924</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133386-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-310097</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>COSTELLO SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTROPHIC CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUTROPIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>019676</drugauthorizationnumb>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUTROPIN</medicinalproduct>
        <drugauthorizationnumb>019676</drugauthorizationnumb>
        <drugindication>HYPOPITUITARISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133387-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10112763</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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133392-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091222</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GENENTECH-310513</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133393-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-CELGENEUS-062-C5013-10112982</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CC-5013</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CC-5013</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAMIDRONIC ACID</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAMIDRONIC ACID</medicinalproduct>
        <drugindication>OSTEOLYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FILGRASTIM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133394-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2009298690</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>INTRACRANIAL PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC DISC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITROFURANTOIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESILATE</medicinalproduct>
        <drugauthorizationnumb>019787</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALFACALCIDOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133395-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-PFIZER INC-2010159042</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AROMASIN</medicinalproduct>
        <drugauthorizationnumb>020753</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133396-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010117340</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>STARTER PACK AND CONTINOUS PACK</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081009</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133397-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-HQWYE164302JUN04</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>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133398-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2010160037</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>
      <patientweight>76</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugauthorizationnumb>020246</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
        <drugtreatmentduration>136</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133399-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2006018620</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DISPENSING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT LOSS POOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPHAGAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHONDROITIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALERIANA COMP</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCRIPTIN A/D</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133400-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-PFIZER INC-2010156615</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUNNEL VISION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 3X/DAY</drugdosagetext>
        <drugindication>POST-TRAUMATIC STRESS DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>150 MG, 3X/DAY</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARCOXIA</medicinalproduct>
        <drugdosagetext>120 MG, 1X/DAY</drugdosagetext>
        <drugindication>POST-TRAUMATIC STRESS DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMODENE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
        <drugdosagetext>10 MG, 3X/DAY</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE</medicinalproduct>
        <drugdosagetext>37.5 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133401-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CZ-PFIZER INC-2010154221</companynumb>
    <primarysource>
      <reportercountry>CZECH REPUBLIC</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>INTRAOCULAR PRESSURE INCREASED</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>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133402-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010044707</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 PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTATIC RENAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>12.5 MG, 4X/DAY, X 28 DAYS EVERY 42 DAYS</drugdosagetext>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100930</drugenddate>
        <drugtreatmentduration>203</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133403-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2010158532</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133404-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010094932</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>49.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>25 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST HERPETIC NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100829</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100714</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100727</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19820407</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TACHYCARDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19820407</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugdosagetext>80 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19820407</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIBENOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031229</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>8-HOUR BAYER</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LACUNAR INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19820407</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST HERPETIC NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040818</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANPLAG</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRODERM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19820914</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133405-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-PFIZER INC-2010157545</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</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>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>020151</drugauthorizationnumb>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133406-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-HQWYE132010AUG04</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>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>2.5-1.0 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRATEST</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTROGENS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE</medicinalproduct>
        <drugdosagetext>37.5 MG</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133408-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010122530</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>25 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST HERPETIC NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100921</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>50 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100930</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
        <drugdosagetext>15 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISUMIC</medicinalproduct>
        <drugdosagetext>10 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NESPO ^AMGEN^</medicinalproduct>
        <drugdosagetext>120 UG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCALTROL</medicinalproduct>
        <drugdosagetext>1.5 UG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPOPARATHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE HCL</medicinalproduct>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>60 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>2.1 MG, DAY</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARASENA A</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100923</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANPEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAUZELIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEPETAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>D-SORBITOL/GLYCERIN/NA CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALESION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARBEPOETIN ALFA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133409-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100318</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GENENTECH-310506</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>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133410-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-GENENTECH-305544</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>375 MG/M2, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GRAFT VERSUS HOST DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>375 MG/M2, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133411-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-CEPHALON-2010006179</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTIQ</medicinalproduct>
        <drugauthorizationnumb>020747</drugauthorizationnumb>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>LUNG DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133412-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GENENTECH-309935</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>LUCENTIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133413-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GILEAD-2010-0033902</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNE RECONSTITUTION SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT ASCITES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugauthorizationnumb>021752</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXIVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133414-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100512</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GENENTECH-310504</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133415-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091223</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GENENTECH-310508</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>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133416-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201009003981</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</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, UNKNOWN</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133417-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GENENTECH-310511</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133418-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-WATSON-2010-15397</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>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>076685</drugauthorizationnumb>
        <drugdosagetext>40 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE IIA HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>TYPE IIA HYPERLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133419-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-WATSON-2010-15297</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION DURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOLILOQUY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STARING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TARDIVE DYSKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>071250</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133420-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-WATSON-2010-15398</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>076928</drugauthorizationnumb>
        <drugdosagetext>875 MG, DAILY</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>076928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>063</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133421-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-WATSON-2010-15421</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>BLOOD 25-HYDROXYCHOLECALCIFEROL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMAGNESAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>075347</drugauthorizationnumb>
        <drugdosagetext>20 MG, DAILY</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133422-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-WATSON-2010-15394</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>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>076685</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDICOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133423-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-WATSON-2010-15389</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>ACUTE HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IMMUNOGLOBULIN E INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CACHEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>080354</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NELFINAVIR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANTIRETROVIRAL THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANTIRETROVIRAL THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANTIRETROVIRAL THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133424-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010DE22216</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.388</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>10MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100818</drugenddate>
        <drugtreatmentduration>336</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>10MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133425-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2008US11042</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80.726</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BARRETT'S OESOPHAGUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PHOSPHORUS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE SARCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA NODOSUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOITRE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODULE ON EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL HYPOMOTILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEM CELL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROIDECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugdosagetext>3 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugdosagetext>4 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>500 MG, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>40 MG, QW</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>0.75 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELCHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYTOCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISACODYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPEUTICS NOS</medicinalproduct>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GARLIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUTRA-PHOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133426-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP79093</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>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INTERFERON ALFA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090617</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUNITINIB MALATE</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100430</drugenddate>
        <drugtreatmentduration>72</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SORAFENIB TOSILATE</medicinalproduct>
        <drugdosagetext>800 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100217</drugenddate>
        <drugtreatmentduration>245</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133427-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US03406</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANCER PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED INTEREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACET JOINT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURED SACRUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONEAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLASMACYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST HERPETIC NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UMBILICAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTIM</medicinalproduct>
        <drugdosagetext>1%</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIPLE VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMUCIL-2</medicinalproduct>
        <drugdosagetext>0.52 GM</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>500 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>37.5</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>VIA PUMP</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INFLUENZA VIRUS VACCINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANDROGEL</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECORTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133428-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP79095</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>TUMOUR HAEMORRHAGE</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>20101020</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133429-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US11285</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.388</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPIRATION PLEURAL CAVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED INTEREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES SIMPLEX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIFE EXPECTANCY SHORTENED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOOSE TOOTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO CENTRAL NERVOUS SYSTEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTATIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080218</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugdosagetext>250 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>800 MG, 2 X DAILY</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENICILLIN VK</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGESTROL ACETATE</medicinalproduct>
        <drugdosagetext>40 MG/ML, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
        <drugdosagetext>100000 U/ML, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN - SLOW RELEASE</medicinalproduct>
        <drugdosagetext>1000/62.5</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPEUTICS NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
        <drugdosagetext>2MG AS NEEDED EVERY 4 HOURS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABRAXANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugdosagetext>UNK / 1 CAPSULE B I D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELATONIN</medicinalproduct>
        <drugdosagetext>20 MG / AT BEDTIME</drugdosagetext>
        <drugindication>COLONY STIMULATING FACTOR PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUTAMINE</medicinalproduct>
        <drugdosagetext>10 G /  T I D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>REFLUX GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS NOS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
        <drugdosagetext>100MG / B.I.D.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CULTURELLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugdosagetext>200 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENZYMES</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>L-CARNITINE                        /00878601/</medicinalproduct>
        <drugdosagetext>1500 MG / B.I.D.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GELCLAIR                                /USA/</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMVIR                                  /NET/</medicinalproduct>
        <drugdosagetext>500 MG / T.I.D.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugdosagetext>500 MG / DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>0.25 MG</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugdosagetext>8 MG/ PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugdosagetext>10 MG / PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHOSPHORUS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMCITABINE HCL</medicinalproduct>
        <drugdosagetext>200MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>50 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PALONOSETRON</medicinalproduct>
        <drugdosagetext>0.25MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTIVASE</medicinalproduct>
        <drugdosagetext>2 MG/ 2 ML</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARBEPOETIN ALFA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE</medicinalproduct>
        <drugdosagetext>0.4 MG / 1 ML</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE</medicinalproduct>
        <drugdosagetext>50  MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORMAL SALINE</medicinalproduct>
        <drugdosagetext>100 ML</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGFILGRASTIM</medicinalproduct>
        <drugdosagetext>6 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIMETIDINE</medicinalproduct>
        <drugdosagetext>300 MG / 50 ML</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMENTIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALACICLOVIR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTAZIDIME</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE W/SALMETEROL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>2 MG / ML</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>6 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VISIPAQUE</medicinalproduct>
        <drugdosagetext>100 ML</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE HYCLATE</medicinalproduct>
        <drugdosagetext>100 MG CAPSULES</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugdosagetext>1 MG TABLETS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133431-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010GB17985</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>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONATE T29581+SOLINJ+BM</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORMONES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>150MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080105</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133432-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010KR16625</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>44</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED GASTRIC EMPTYING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>7.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101030</drugenddate>
        <drugtreatmentduration>158</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugdosagetext>800 MG/M^2</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101030</drugenddate>
        <drugtreatmentduration>158</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>100 MG/M^2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101026</drugenddate>
        <drugtreatmentduration>154</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133433-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010TW10616</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMMONIA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONCOMITANT DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugdosagetext>PLACEBO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANCREATIC NEUROENDOCRINE TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100613</drugenddate>
        <drugtreatmentduration>455</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAD001C</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>10 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANCREATIC NEUROENDOCRINE TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100703</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAD001C</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>5MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100704</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULPIRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMILORIDE HCL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133434-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US81616</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133435-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010DE13393</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>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>JAW OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, EVERY 4 WEEKS</drugdosagetext>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100808</drugenddate>
        <drugtreatmentduration>116</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100816</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100817</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELIGARD</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133436-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2008US11782</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071122</drugenddate>
        <drugtreatmentduration>1047</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugdosagetext>50 MG (50 MG CYCLIC : 4 WKS ON, 2 WKS OFF)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071227</drugenddate>
        <drugtreatmentduration>582</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugdosagetext>NO TREATMENT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080202</drugenddate>
        <drugtreatmentduration>37</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugdosagetext>50 MG / DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080203</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133437-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010DE81008</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>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090915</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133438-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010US17490</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK COMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOTRACHEAL INTUBATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHOSPHATAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONEAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>35MG/WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMPARATOR SORAFENIB</medicinalproduct>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAXAGLIPTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133439-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2008US02534</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>ALCOHOLIC LIVER DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE CALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIAL INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIAL OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTERIXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IRON DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC PACEMAKER INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID INTIMA-MEDIA THICKNESS INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL PLAQUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION ATRIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION VENTRICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPTY SELLA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDARTERECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDODONTIC PROCEDURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAILURE TO THRIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABILE HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG LOBECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY MEDIASTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE CALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL SEPTUM DEVIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-SMALL CELL LUNG CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEPTIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL CALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN GRAFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR GRAFT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
        <drugdosagetext>10 MG DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPULSID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM CD</medicinalproduct>
        <drugdosagetext>240 MG DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITEK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIKET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM SILVER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TETRACYCLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN ^AVENTIS PHARMA^</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOMOTIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACITRACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISACODYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUONEB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILK OF MAGNESIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUPIROCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133440-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010NZ17406</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR CAUTERISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>10MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101115</drugenddate>
        <drugtreatmentduration>39</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101123</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133441-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA81036</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100127</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133442-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010NL81415</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TERMINAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG/5 ML</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133443-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR80726</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugbatchnumb>UNK.</drugbatchnumb>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5MG/100ML</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090611</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133444-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010135570</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BIPOLAR I DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE-COMPULSIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</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>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</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>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>3 MG</drugdosagetext>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>1 MG, 3X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133445-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010117317</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL SELF-INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MAJOR DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>STARTER PACK AND CONTINUING PACKS</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND HYDROCODONE BITARTRATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133446-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010120524</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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE STRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>CONTINUING MONTH PACKS FOR SIX MONTHS</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133447-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006591</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALATAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugdosagetext>2500 UNIT, 2 TIMES/WK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARBEPOETIN ALFA</medicinalproduct>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>1 MG, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>750 UNK, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugdosagetext>4 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN A</medicinalproduct>
        <drugdosagetext>100 IU, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, QOD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
        <drugdosagetext>0.25 A?G, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133448-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-WATSON-2010-15275</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENTERA (WATSON LABORATORIES)</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021351</drugauthorizationnumb>
        <drugdosagetext>^2 X WEEK^</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101020</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133449-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MYLANLABS-2010S1020380</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>68.95</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERFOROMIST</medicinalproduct>
        <drugauthorizationnumb>022007</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133450-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-GILEAD-2010-0033841</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</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>TRUVADA</medicinalproduct>
        <drugauthorizationnumb>021752</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133451-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MYLANLABS-2010S1019925</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>78.02</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMNESTEEM</medicinalproduct>
        <drugauthorizationnumb>075945</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE CYSTIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMNESTEEM</medicinalproduct>
        <drugauthorizationnumb>075945</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCAR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN-SR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENEX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUMS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133452-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MYLANLABS-2010S1019678</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>DRUG EXPOSURE BEFORE PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMNESTEEM</medicinalproduct>
        <drugauthorizationnumb>075945</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARAVIS</medicinalproduct>
        <drugauthorizationnumb>075945</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100810</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133453-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AMGEN-DEUSP2010006274</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>UNK, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100817</drugenddate>
        <drugtreatmentduration>440</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugdosagetext>160 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTRIM</medicinalproduct>
        <drugdosagetext>960 MG, 3 TIMES/WK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>400 UNK, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HCT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AQUAPHOR                           /00298701/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133454-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-JPNCT2010007111</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANITUMUMAB</medicinalproduct>
        <drugdosagetext>UNK UNK, Q2WK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM LEVOFOLINATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133455-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-RA-00484MX</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>42</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DABIGATRAN ETEXILATE</medicinalproduct>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>220 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ISCHAEMIC CARDIOMYOPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASILACTON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ISCHAEMIC CARDIOMYOPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133456-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13077BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>003995A,0C2200</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133457-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MYLANLABS-2010S1019562</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>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMNESTEEM</medicinalproduct>
        <drugauthorizationnumb>075945</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMNESTEEM</medicinalproduct>
        <drugauthorizationnumb>075945</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133458-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MYLANLABS-2010S1021533</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>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMNESTEEM</medicinalproduct>
        <drugauthorizationnumb>075945</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONTRACEPTIVES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133459-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-MEDIMMUNE-MEDI-0011843</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>4.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SENSE OF OPPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101025</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133460-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033804</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugauthorizationnumb>021356</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100923</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPZICOM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100923</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100923</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133461-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MYLANLABS-2010S1020373</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>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMNESTEEM</medicinalproduct>
        <drugauthorizationnumb>075945</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAL CONTRACEPTIVE NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILNACIPRAN</medicinalproduct>
        <drugdosagetext>SAVELLA (MILNACIPRAN)</drugdosagetext>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133463-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE201011002610</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>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL ABOVE THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPADHERA</medicinalproduct>
        <drugauthorizationnumb>022173</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPADHERA</medicinalproduct>
        <drugauthorizationnumb>022173</drugauthorizationnumb>
        <drugdosagetext>200 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133464-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE201011005021</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION SUICIDAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>90 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>90 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133465-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MYLANLABS-2010S1015661</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>136.08</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
        <drugbatchnumb>6B0005</drugbatchnumb>
        <drugauthorizationnumb>076258</drugauthorizationnumb>
        <drugdosagetext>Q 72 HOURS</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100818</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugindication>BREAKTHROUGH PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAXATIVE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133466-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MYLANLABS-2006S1006216</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHANGIOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN FRAGILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN STRIAE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MERCAPTAMINE BITARTRATE</medicinalproduct>
        <drugauthorizationnumb>020392</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CYSTINOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MERCAPTAMINE BITARTRATE</medicinalproduct>
        <drugauthorizationnumb>020392</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MERCAPTAMINE BITARTRATE</medicinalproduct>
        <drugauthorizationnumb>020392</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MERCAPTAMINE BITARTRATE</medicinalproduct>
        <drugauthorizationnumb>020392</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFACALCIDOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMATROPIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040320</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM BICARBONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19921125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM POTASSIUM PHOSPHATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910709</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>L-CARNITHINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060306</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133467-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-GILEAD-2010-0033793</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugauthorizationnumb>021356</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENTECAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090311</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133468-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2008BH010994</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAIL DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODAL ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080328</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080328</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080403</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</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>DIGOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</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>PROVENTIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</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>NIFEDIPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133469-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2008BH003078</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>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AIR EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PHOSPHORUS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>037059</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>047092</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>037059</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>027106</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>047095</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>027106</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHOSLO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ELECTROLYTE IMBALANCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SORBITOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEPHROCAPS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ CODEINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133470-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2008BH011001</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CATHETERISATION CARDIAC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CORONARY ARTERY BYPASS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CATHETER PLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071231</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071231</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071231</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071231</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071231</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071231</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071231</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071231</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071231</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071231</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071231</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071231</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABETALOL HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORMODYNE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VISIPAQUE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</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>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</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>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOMYST                                /USA/</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORADOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
        <drugadministrationroute>042</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>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMEROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFUROXIME</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROBITUSSIN DM                           /USA/</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133471-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2008BH011003</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>BLOODY DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JUGULAR VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORGANISING PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SECRETION DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INDWELLING CATHETER MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070829</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070829</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070829</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070829</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <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>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ PROPOXYPHENE HCL</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>METHOTREXATE</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>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVALBUTEROL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE SODIUM SUCCINATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
        <drugadministrationroute>065</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>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTAMINE SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOFLURANE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133472-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2009BH011767</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050407</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050407</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080311</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080311</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080318</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080318</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugadministrationroute>058</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>LEVOTHYROXINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHOSLO</medicinalproduct>
        <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>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
        <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>MULTI-VITAMIN</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>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENSIPAR</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>ZEMPLAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEMOCYTE TABLET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </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>ZOFRAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROPOIETIN</medicinalproduct>
        <drugadministrationroute>065</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>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUSOPT</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEFLEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STOOL SOFTENER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MACRODANTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133473-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2009BH012612</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>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CATHETERISATION CARDIAC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070805</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070804</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070807</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLCYSTEINE</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>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN ^A.L.^</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERSED</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL ^ACHE^</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOPHED</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133474-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH002693</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD OSMOLARITY INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID OVERLOAD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NYSTAGMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEPHRO-VITE RX</medicinalproduct>
        <drugadministrationroute>065</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>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMNICEF</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133475-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH027200</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>GANGRENE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133476-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAXTER-2010BH028270</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PERITONITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>GLOMERULONEPHRITIS CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101114</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133477-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-ABBOTT-10P-082-0677799-00</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLICATION OF PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REDUCTIL 15MG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020632</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBESITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REDUCTIL 15MG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020632</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133478-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-ABBOTT-10P-009-0687587-00</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PUSTULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EROSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOLOC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XEFO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133479-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ABBOTT-10P-013-0686756-00</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LYMPH NODES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCRIN DEPOT 11.25 MG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020708</drugauthorizationnumb>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BICALUTAMIDE</medicinalproduct>
        <drugdosagetext>FORM STRENGTH: 50MG</drugdosagetext>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071031</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133480-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-10P-087-0688944-00</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020708</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER STAGE II</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080716</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BICALUTAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER STAGE II</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BICALUTAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100310</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133481-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-09P-087-0597063-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090828</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080418</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FOLATE DEFICIENCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081010</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090915</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133482-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-ABBOTT-10P-161-0617958-00</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE FOR DATES BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL DRUGS AFFECTING FOETUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REDUCTIL 15MG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020632</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133483-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>UG-ABBOTT-10P-165-0687773-00</companynumb>
    <primarysource>
      <reportercountry>UGANDA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEILITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALUVIA TABLETS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021906</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100824</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RALTEGRAVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100824</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTRIMOXAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100726</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100726</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100726</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133484-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0687567-00</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>DIVERTICULUM INTESTINAL HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE WOUND INFECTION</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>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTIVA</medicinalproduct>
        <drugindication>GASTRIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMUCIL TYPE MEDICATION</medicinalproduct>
        <drugindication>ABNORMAL FAECES</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133485-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-10P-020-0687477-00</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090624</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133486-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010136954</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>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133487-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010134100</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>
      <patientweight>67.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugauthorizationnumb>021130</drugauthorizationnumb>
        <drugdosagetext>600 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugdosagetext>200 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
        <drugdosagetext>500 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUSTAZOL</medicinalproduct>
        <drugdosagetext>20 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugdosagetext>100 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEO-DUR</medicinalproduct>
        <drugdosagetext>100 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITOROL</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMITT</medicinalproduct>
        <drugdosagetext>250 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133488-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2010097163</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133489-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2010133009</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100302</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133490-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2010129625</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELDOX</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugdosagetext>160 MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELDOX</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugdosagetext>60MG IN THE MORNING, 40MG IN THE AFTERNOON, 20MG IN THE EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELDOX</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugdosagetext>60MG IN THE MORNING, 40MG IN THE EVENING</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLON</medicinalproduct>
        <drugdosagetext>7.5 MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133491-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2010160207</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</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>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>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugindication>HYPERTRIGLYCERIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133492-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-PFIZER INC-2010148875</companynumb>
    <primarysource>
      <reportercountry>FINLAND</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>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133493-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2010160216</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</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>TACHYCARDIA</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>20101108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133494-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2010162248</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>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STUPOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>1 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101121</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE</medicinalproduct>
        <drugdosagetext>2.5 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NUELIN SA</medicinalproduct>
        <drugdosagetext>250 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL</medicinalproduct>
        <drugdosagetext>2 DF, AS NEEDED</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugdosagetext>2 DF, 2X/DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133495-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2010156815</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURITIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>100 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101010</drugenddate>
        <drugtreatmentduration>2155</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUTRANS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICRONOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133496-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160537</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>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133497-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2010160222</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</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>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133498-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-PFIZER INC-2010128407</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISINHIBITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANNABIS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133499-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2010159502</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FRONTAL</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugdosagetext>0.25 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101127</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FRONTAL</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133500-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2009179826</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>ADJUSTMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALCOHOL ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHIATRIC SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>200 MG, 1X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>300 MG, 1X/DAY</drugdosagetext>
        <drugindication>HYPERURICAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050817</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133501-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010158848</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SUBILEUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133502-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US79591</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>190</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG ONCE PER YEAR</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LONTULO</medicinalproduct>
        <drugdosagetext>7.5</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDODERM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLUSTON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT                               /GFR/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZEMPLAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FREESTYLE GLUCOSE STWPS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLBEE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUWSENBTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133503-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010AR13525</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RALES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACZ885 ACZ+</medicinalproduct>
        <drugdosagetext>EVERY 8 WEEKS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CHRONIC INFANTILE NEUROLOGICAL CUTANEOUS AND ARTICULAR SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100729</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>0.6 MG/KG PER DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133504-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010EC81022</companynumb>
    <primarysource>
      <reportercountry>ECUADOR</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>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133505-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-BAXTER-2010BH028437</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>5% DEXTROSE INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MESNA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</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>2</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</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>DIPHENHYDRAMINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133506-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101121</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-MEDIMMUNE-MEDI-0011837</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>4.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGODIPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100925</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133507-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-MEDIMMUNE-MEDI-0011717</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>6.69</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RALES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSE OF OPPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101122</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133508-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GENENTECH-310253</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133509-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-MEDIMMUNE-MEDI-0011596</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>9.15</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY SYNCYTIAL VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>BRONCHOPULMONARY DYSPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100107</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133510-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GENENTECH-309576</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>GASTRIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133511-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2010SE52882</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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 INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG CARCINOMA CELL TYPE UNSPECIFIED RECURRENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>021399</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100616</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133512-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-310314</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133513-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GENENTECH-309933</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101025</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133514-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070430</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GENENTECH-310509</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECURRENT CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133515-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BR-02752BR</companynumb>
    <primarysource>
      <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>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENSINA</medicinalproduct>
        <drugauthorizationnumb>017407</drugauthorizationnumb>
        <drugdosagetext>0.6 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133516-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13323BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAIR 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>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133517-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010121904</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>120</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugauthorizationnumb>021267</drugauthorizationnumb>
        <drugdosagetext>600 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ASPERGILLOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100922</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugauthorizationnumb>021267</drugauthorizationnumb>
        <drugdosagetext>400 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101123</drugenddate>
        <drugtreatmentduration>62</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GUAIFENESIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133518-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010128182</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCOLATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORADIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERBUTALINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133519-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010157252</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>14.059</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOMATROPIN</medicinalproduct>
        <drugauthorizationnumb>020280</drugauthorizationnumb>
        <drugdosagetext>0.3 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRADER-WILLI SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100713</drugenddate>
        <drugtreatmentduration>827</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133520-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010159688</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>VFEND</medicinalproduct>
        <drugauthorizationnumb>021266</drugauthorizationnumb>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugindication>ASPERGILLOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133521-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010159635</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87.982</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133522-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010129561</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>120.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>READING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugauthorizationnumb>021130</drugauthorizationnumb>
        <drugdosagetext>600 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101004</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>1000 MG, 2X/DAY</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugdosagetext>10 MG, DAILY</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133523-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161628</companynumb>
    <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>VFEND</medicinalproduct>
        <drugauthorizationnumb>021266</drugauthorizationnumb>
        <drugdosagetext>200 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100922</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133524-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-GENENTECH-310136</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101030</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133525-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US80874</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>RECLAST</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG, YEARLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133526-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US81399</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070731</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133527-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BAXTER-2010BH014344</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>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HOLOXAN BAXTER</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LEIOMYOSARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100518</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LEIOMYOSARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100518</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UROMITEXAN BAXTER</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100518</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100518</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100518</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133528-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BAXTER-2010BH027864</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>ACUTE PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILATREND</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</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>ZOFRAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URBASON SOLUBILE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133529-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2008BH011004</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 DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIDIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <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>ESZOPICLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABETALOL HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HECTOROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYOSCYAMINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</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>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUCRALFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIATX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOMETASONE FUROATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM ACETATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</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>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133530-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2009BH014517</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>
      <patientweight>119</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>087125</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>097082</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>107024</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>087125</drugbatchnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>097081</drugbatchnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>107024</drugbatchnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <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>INSULIN HUMAN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHOSLO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASACORT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>055</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>ALLEGRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASMANEX TWISTHALER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXERCALCIFEROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</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>LANTUS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133531-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH006218</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>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRRHOSIS ALCOHOLIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONEAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DEHISCENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071218</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071218</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071226</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071226</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFAZOLIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIMETIDINE</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>2</drugcharacterization>
        <medicinalproduct>THIAMINE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN K TAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFEPIME</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHYTONADIONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM PHOSPHATE MONOBASIC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUMARC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYLEPHRINE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULCOLAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYLANTA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACITRACIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORHEXIDINE GLUCONATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTACIDS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUMIN (HUMAN)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133532-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-GB-WYE-H14619610</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD MAGNESIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugauthorizationnumb>018972</drugauthorizationnumb>
        <drugdosagetext>200 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPRAVENTRICULAR TACHYCARDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100225</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugdosagetext>500 MG, 3X/WK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100225</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOCISTEINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133533-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010159562</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BURNING MOUTH SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYNEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133534-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010159953</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.238</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugauthorizationnumb>021130</drugauthorizationnumb>
        <drugdosagetext>600 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PEAU D'ORANGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101123</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugauthorizationnumb>021130</drugauthorizationnumb>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
        <drugdosagetext>150 MG, 3X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugindication>ABDOMINAL DISCOMFORT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133535-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-PFIZER INC-ES-WYE-H18264510</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FACTOR VIII INHIBITION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REFACTO</medicinalproduct>
        <drugbatchnumb>51079</drugbatchnumb>
        <drugdosagetext>3000 IU ON DEMAND</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FACTOR VIII DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOROCTOCOG ALFA</medicinalproduct>
        <drugbatchnumb>61712</drugbatchnumb>
        <drugdosagetext>3000 IU ON DEMAND</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOROCTOCOG ALFA</medicinalproduct>
        <drugbatchnumb>61412</drugbatchnumb>
        <drugdosagetext>3000 IU ON DEMAND</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOROCTOCOG ALFA</medicinalproduct>
        <drugbatchnumb>61411</drugbatchnumb>
        <drugdosagetext>3000 IU ON DEMAND</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090922</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133536-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2009241057</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROGENIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugauthorizationnumb>021130</drugauthorizationnumb>
        <drugdosagetext>600 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTERVERTEBRAL DISCITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081009</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugauthorizationnumb>021130</drugauthorizationnumb>
        <drugdosagetext>600 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090127</drugenddate>
        <drugtreatmentduration>95</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>2.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDAREX</medicinalproduct>
        <drugdosagetext>200 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVALGIN</medicinalproduct>
        <drugdosagetext>500 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081009</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>TOREM</medicinalproduct>
        <drugdosagetext>10 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080729</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>XIPAMIDE</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081008</drugenddate>
        <drugtreatmentduration>72</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>1 G, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081003</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
        <drugdosagetext>50 MG, 2X/DAY</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081008</drugenddate>
        <drugtreatmentduration>72</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugdosagetext>95 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEXANE</medicinalproduct>
        <drugdosagetext>60 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081007</drugenddate>
        <drugtreatmentduration>71</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITOXIN</medicinalproduct>
        <drugdosagetext>0.07 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE</medicinalproduct>
        <drugdosagetext>10 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133537-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US76209</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>DYSTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FANAPT</medicinalproduct>
        <drugauthorizationnumb>022192</drugauthorizationnumb>
        <drugdosagetext>8 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133538-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010DE78057</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>CARDIAC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICTURITION URGENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>160 MG ONCE DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugdosagetext>160/12.5 MG ONCE DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORADIL</medicinalproduct>
        <drugdosagetext>TWICE DAILY</drugdosagetext>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WATER TABLET</medicinalproduct>
        <drugdosagetext>10 MG (1-1/2-0)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WATER TABLET</medicinalproduct>
        <drugdosagetext>10 MG (1/2-0-0)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WATER TABLET</medicinalproduct>
        <drugdosagetext>5 MG (HALF TABLET PER DAY)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE</medicinalproduct>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133539-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-BAXTER-2010BH026806</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</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>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133540-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-296842</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE FRACTURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOLOGICAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>S0072C</drugbatchnumb>
        <drugdosagetext>300 MG, Q2W</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050425</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>S0078B</drugbatchnumb>
        <drugdosagetext>300 MG, Q2W</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133541-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-10P-062-0664524-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLANGITIS SCLEROSING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133542-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-10P-062-0667480-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROGENIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIRENAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PITYRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMATIC COMPRESSION THERAPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEBORRHOEIC DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROMA</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>20090414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERRLECIT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLGAMMA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXFORGE</medicinalproduct>
        <drugdosagetext>10 MG/160 MG, 1 IN 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINIASAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECOSTRIOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIPHOSPHAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSRENOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METO-SUCCINAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI-KALIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYPO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AEB 071 STUDY MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
        <drugdosagetext>1 PIPETTE</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTRIM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DALTEPARIN SODIUM</medicinalproduct>
        <drugdosagetext>OPD</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVEROLIMUS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REDUCTO SPEZIAL (K-DIHYDROGE-P/NA-MONOHYDROGEN-P)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URBASON</medicinalproduct>
        <drugdosagetext>OPD</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BELOC ZOK MITE (METOPROLOLSUCCINAT)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
        <drugdosagetext>OPD</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMULOSIN</medicinalproduct>
        <drugdosagetext>OPD</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALCYTE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133543-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0688885-00</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>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020945</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050805</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATAZANAVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050805</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133544-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-10P-062-0670195-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROSACEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURINETHOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>GASTRIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133545-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-10P-087-0688947-00</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER STAGE II</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020708</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER STAGE II</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BICALUTAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER STAGE II</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUFFERIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEVALOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133546-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100407</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TN-ABBOTT-10P-160-0637561-00</companynumb>
    <primarysource>
      <reportercountry>TUNISIA</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>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugbatchnumb>69441V1</drugbatchnumb>
        <drugauthorizationnumb>020478</drugauthorizationnumb>
        <drugdosagetext>DOSE INTUBATION6% DOSE MAINTENANCE3%</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>SCLEROTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100331</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133547-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ABBOTT-10P-114-0687769-00</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCRIN DEPOT 11.25 MG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020708</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>LEIOMYOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091002</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133548-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-ABBOTT-10P-082-0678983-00</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAPULMONARY TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROTISING GRANULOMATOUS LYMPHADENITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133549-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100715</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-20785-10060342</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PREGNANCY OF PARTNER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>020785</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LEPROMATOUS LEPROSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugdosagetext>200MG-100MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133550-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MPIJNJ-2010-05896</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>VELCADE</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugauthorizationnumb>021602</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDARABINE</medicinalproduct>
        <drugindication>CORD BLOOD TRANSPLANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>CORD BLOOD TRANSPLANT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133551-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MILLENNIUM PHARMACEUTICALS, INC.-2010-05898</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>VELCADE</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugauthorizationnumb>021602</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDARABINE</medicinalproduct>
        <drugindication>CORD BLOOD TRANSPLANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>CORD BLOOD TRANSPLANT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133552-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MILLENNIUM PHARMACEUTICALS, INC.-2010-05897</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>VELCADE</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugauthorizationnumb>021602</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDARABINE</medicinalproduct>
        <drugindication>CORD BLOOD TRANSPLANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>CORD BLOOD TRANSPLANT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133553-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MPIJNJ-2010-05907</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>27.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugauthorizationnumb>021602</drugauthorizationnumb>
        <drugdosagetext>1.3 MG/M2, CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRECURSOR T-LYMPHOBLASTIC LYMPHOMA/LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100618</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>20 MG/M2, CYCLIC</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRECURSOR T-LYMPHOBLASTIC LYMPHOMA/LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>PRECURSOR T-LYMPHOBLASTIC LYMPHOMA/LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>500 MG/M2, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>60 MG/M2, CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRECURSOR T-LYMPHOBLASTIC LYMPHOMA/LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>1.5 MG/M2, CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRECURSOR T-LYMPHOBLASTIC LYMPHOMA/LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRECURSOR T-LYMPHOBLASTIC LYMPHOMA/LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>PRECURSOR T-LYMPHOBLASTIC LYMPHOMA/LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPARAGINASE</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRECURSOR T-LYMPHOBLASTIC LYMPHOMA/LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>440 MG/M2, CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRECURSOR T-LYMPHOBLASTIC LYMPHOMA/LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100615</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>100 MG/M2, CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRECURSOR T-LYMPHOBLASTIC LYMPHOMA/LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100615</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133554-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MILLENNIUM PHARMACEUTICALS, INC.-2010-05916</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.562</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATIC NERVE INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugauthorizationnumb>021602</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>WALDENSTROM'S MACROGLOBULINAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>WALDENSTROM'S MACROGLOBULINAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugdosagetext>4 MG, QD</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILNACIPRAN</medicinalproduct>
        <drugdosagetext>50 MG, BID</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>600 MG, BID</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133555-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BAXTER-2010BH023534</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>CEREBELLAR SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MITOXANTRONE GENERIC</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IDARUBICIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUSULFAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133556-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2008AU37259</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
    </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>STALEVO 100</medicinalproduct>
        <drugauthorizationnumb>021485</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133557-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20081114</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2008AU37260</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
    </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>STALEVO 100</medicinalproduct>
        <drugauthorizationnumb>021485</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133558-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101021</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2009AU36878</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA SCALE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TROPONIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>350 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>1 G, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>3.125 G, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugdosagetext>160 G, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133559-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BE63521</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REBOUND EFFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RILATINE</medicinalproduct>
        <drugauthorizationnumb>010187</drugauthorizationnumb>
        <drugdosagetext>UNK DOSE AT NOON</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133560-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2008BH009162</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAILURE TO THRIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID OVERLOAD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISION SITE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR SUCKING REFLEX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CENTRAL VENOUS CATHETERISATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INTRAVENOUS CATHETER MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PARENTERAL NUTRITION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>027062</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>027062</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>027062</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>H07137</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <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>GRANULOCYTE COLONY STIMULATING FACTOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEFLEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WOUND INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTIVASE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MEDICAL DEVICE COMPLICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMILAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FILGRASTIM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESNA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTAMIDINE ISETHIONATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFEPIME</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</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>ACTIVASE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTAZIDIME</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORAL HYDRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACITRACIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORHEXIDINE GLUCONATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MANNITOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIOTEPA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERSED</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTAZIDIME</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORHEXIDINE GLUCONATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FILGRASTIM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTAMIDINE ISETHIONATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAT EMULSIONS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133561-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2008BH011000</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROMECHANICAL DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HAEMODIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugadministrationroute>062</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>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEPHRO-VITE RX</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>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOLOL</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAVATAN</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARINOL</medicinalproduct>
        <drugadministrationroute>065</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>IRON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HAEMODIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</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>VICODIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMEROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GINKGO BILOBA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133562-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH005951</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>119</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>010</drugadministrationroute>
        <drugindication>HAEMODIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080331</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090327</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHOSLO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDODRINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</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>DIATX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HAEMODIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOETIN ALFA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZEMPLAR</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HECTOROL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133563-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006312</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133564-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ALLERGAN-1015282US</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>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RESTASIS</medicinalproduct>
        <drugauthorizationnumb>050790</drugauthorizationnumb>
        <drugdosagetext>1 GTT, BID</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>BLEPHARITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RESTASIS</medicinalproduct>
        <drugauthorizationnumb>050790</drugauthorizationnumb>
        <drugindication>LACRIMAL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133565-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010088750</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133566-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2010150094</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>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TORISEL</medicinalproduct>
        <drugauthorizationnumb>022088</drugauthorizationnumb>
        <drugdosagetext>25 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133567-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010128884</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>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</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>20091201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133568-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-HQWYE703411OCT04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133569-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-PFIZER INC-2010155431</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ALVEOLAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugauthorizationnumb>011153</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133570-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010156338</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>150 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133571-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010134005</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>REVATIO</medicinalproduct>
        <drugauthorizationnumb>021845</drugauthorizationnumb>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133572-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-US-WYE-H18327110</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>DEJA VU</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SIMPLE PARTIAL SEIZURES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>150.0 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugindication>FATIGUE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44.0 UG,3X/WK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>300 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>750 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE</medicinalproduct>
        <drugdosagetext>112 UG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>25 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133573-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010132609</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 OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</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>7133574-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GENENTECH-310207</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>PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENDAMUSTINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133575-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-ABBOTT-09P-082-0575827-00</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAPULMONARY TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROTISING GRANULOMATOUS LYMPHADENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GOLD</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>CYCLOSPORINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133576-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-10P-167-0679292-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROSTAP 3</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020708</drugauthorizationnumb>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133577-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0674144-00</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>FISTULA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133578-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ABBOTT-10P-083-0687427-00</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>35.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</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>20101102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>2000 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOLEP</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133579-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-10P-087-0687875-00</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>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020708</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133580-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-10P-028-0687756-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.37</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPRON DEPOT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020517</drugauthorizationnumb>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133581-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070913</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GENENTECH-310520</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>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133582-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-GENENTECH-310254</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>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1000 MG, Q15D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100331</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100331</drugenddate>
        <drugtreatmentduration>747</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133583-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033408</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>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133584-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010120523</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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA FACIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB TRAUMATIC AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE INJURIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHANTOM PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST-TRAUMATIC STRESS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>STARTER, CONTINUOUS MONTHS PACKS</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPO-TESTOSTERONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLOOD TESTOSTERONE DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLOOD TESTOSTERONE DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>VITAMIN B12 DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROZEREM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PHANTOM PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANTIBIOTIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASTELIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHINITIS ALLERGIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133585-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010118989</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>
      <patientweight>62</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SILDENAFIL CITRATE</medicinalproduct>
        <drugauthorizationnumb>021845</drugauthorizationnumb>
        <drugdosagetext>20 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101129</drugenddate>
        <drugtreatmentduration>86</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugdosagetext>6.25 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100917</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BAKTAR</medicinalproduct>
        <drugdosagetext>2 DF, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIFUNGAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100917</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
        <drugdosagetext>15 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISCOTIN</medicinalproduct>
        <drugdosagetext>100 G, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100917</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESSNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DELIRIUM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAI-KENCHU-TO</medicinalproduct>
        <drugdosagetext>5 G, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100917</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>0.5 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESSNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100917</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugindication>DELIRIUM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugdosagetext>5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY EMBOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BERAPROST SODIUM</medicinalproduct>
        <drugdosagetext>60 UG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100917</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>0.125 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAINTATE</medicinalproduct>
        <drugdosagetext>2.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100902</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAL</medicinalproduct>
        <drugdosagetext>20 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVEN EP</medicinalproduct>
        <drugdosagetext>1 DF, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugdosagetext>5 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100830</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133586-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2009152238</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEARING IMPAIRED</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>DILANTIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133587-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033955</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TESTICULAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091230</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133588-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033511</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>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100928</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133589-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-10P-167-0687532-00</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>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE COMPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060907</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133590-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033907</companynumb>
    <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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090415</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133591-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033710</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 TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090402</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080815</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133592-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006861</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SENSIPAR</medicinalproduct>
        <drugauthorizationnumb>021688</drugauthorizationnumb>
        <drugindication>HYPERPARATHYROIDISM SECONDARY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133593-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033975</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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133594-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GENENTECH-310518</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 NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</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>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133595-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GENENTECH-310490</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133596-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-AMGEN-CANSP2010006107</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133597-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GENENTECH-309313</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>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTIVASE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>19.8 MIU, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CEREBRAL THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101004</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADICUT</medicinalproduct>
        <drugdosagetext>30 MG, BID</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>CEREBRAL THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101010</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CEREBRAL THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101006</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASODILATOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULBACTAM SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPICILLIN SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133598-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-310454</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133599-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GENENTECH-310517</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>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133600-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-10P-087-0622822-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HISTIOCYTOSIS HAEMATOPHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFZON SUSPENSION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050749</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FAROM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080506</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAC</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080509</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACETCOOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACETCOOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080525</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133601-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-305021</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RETINAL DETACHMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANIBIZUMAB</medicinalproduct>
        <drugbatchnumb>XY62377</drugbatchnumb>
        <drugdosagetext>0.05 UNK, PRN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100524</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133602-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-GENENTECH-310225</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>SECOND INFUSION</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100705</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTEOFORM</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133603-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0907GBR00003</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>CROUP INFECTIOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugauthorizationnumb>011664</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROUP INFECTIOUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133604-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1011USA03225</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>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133605-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-MERCK-1011ESP00032</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugauthorizationnumb>022044</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE AND VALSARTAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOXONIDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133606-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1011USA03450</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>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF LIBIDO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PENIS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPECIA</medicinalproduct>
        <drugauthorizationnumb>020788</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ALOPECIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090930</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133607-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-1011USA03519</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>HEPATITIS CHRONIC ACTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugauthorizationnumb>020387</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133608-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-1010USA02803</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>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISEDRONATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLOMERULONEPHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133609-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0902USA00994</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>APHTHOUS STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASTICATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL TORUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMALACIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY SLEEP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE ODOUR ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE DENSITY DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080630</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080630</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133610-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0911USA02195</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>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICAL DYSPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC MUCOSAL HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUMAN PAPILLOMA VIRUS TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED TENDENCY TO BRUISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133611-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-MERCK-1011ESP00029</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>PARKINSON'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133612-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1002USA02326</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>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SPRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090501</drugenddate>
        <drugtreatmentduration>1958</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080819</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030201</drugenddate>
        <drugtreatmentduration>264</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090511</drugenddate>
        <drugtreatmentduration>53</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090301</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19820101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19820101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133613-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1003USA01611</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>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTIGMATISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY HEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING MOUTH SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID BRUIT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORNEAL DYSTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CUTIS LAXA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELAYED RECOVERY FROM ANAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERMITTENT CLAUDICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR LENS IMPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPLAKIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LICHEN PLANUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAROTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEPTIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL ARTERIAL OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBCLAVIAN STEAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN B12 DEFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090317</drugenddate>
        <drugtreatmentduration>1175</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>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090317</drugenddate>
        <drugtreatmentduration>1175</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELDENE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELDENE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SPINAL OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIDEPRESSANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE RELAXANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133614-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0907USA02923</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>69</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL ADHESIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADHESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIARY DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EDENTULOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST-T CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEORADIONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULPITIS DENTAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOULDER DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENIC INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBCUTANEOUS ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH RESORPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICOSE VEIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133615-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0911USA02010</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>
      <patientweight>71</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS DRAINAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENIGN BREAST NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL ALVEOLAR ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIAPHRAGMATIC HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISLOCATION OF VERTEBRA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EDENTULOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESSENTIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROCYSTIC BREAST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DISPLACEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR SPINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS EXTERNA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS MEDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTERIOR CAPSULE OPACIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRIMARY SEQUESTRUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DEPOSIT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080920</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIROXICAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133616-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CG-MERCK-1011USA02259</companynumb>
    <primarysource>
      <reportercountry>CONGO</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ONCHOCERCIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101005</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133617-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1011USA03226</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>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133618-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-MERCK-0701CAN00049</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD THYROID STIMULATING HORMONE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERUMEN IMPACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GROIN PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HELICOBACTER GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED SELF-CARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN CELL VOLUME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE FRACTURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DYSAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIUS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLOLISTHESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVIAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULNA FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIITH NERVE PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060320</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISEDRONATE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133619-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-1009USA04665</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>40</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100812</drugenddate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133620-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CG-MERCK-1011USA02258</companynumb>
    <primarysource>
      <reportercountry>CONGO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ONCHOCERCIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101005</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133621-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1003USA03105</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>47</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOCTURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIODONTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERNICIOUS ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETIT MAL EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN B12 DEFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001201</drugenddate>
        <drugtreatmentduration>398</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
        <drugtreatmentduration>250</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080401</drugenddate>
        <drugtreatmentduration>740</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050601</drugenddate>
        <drugtreatmentduration>1261</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133622-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0705USA01437</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACQUIRED OESOPHAGEAL WEB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID PTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL FOOD IMPACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFLUX OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPOROMANDIBULAR JOINT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH LOSS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>021575</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>021575</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>021575</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>021575</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROSTAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIVERT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIVERT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIZZINESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAGAMET</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133623-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SI-AMGEN-SVNNI2010005208</companynumb>
    <primarysource>
      <reportercountry>SLOVENIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CINACALCET HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>021688</drugauthorizationnumb>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPARATHYROIDISM SECONDARY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugdosagetext>80 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugdosagetext>UNK UNK, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCII CARBONAS</medicinalproduct>
        <drugdosagetext>1 G, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100912</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLURENORM</medicinalproduct>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
        <drugdosagetext>4 G, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOPURINOL</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOPRIL</medicinalproduct>
        <drugdosagetext>20 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORYOL</medicinalproduct>
        <drugdosagetext>25 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONTROLOC                          /01263201/</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
        <drugdosagetext>800 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TANYZ                              /01280301/</medicinalproduct>
        <drugdosagetext>400 A?G, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZEMPLAR</medicinalproduct>
        <drugdosagetext>1 A?G, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TONOCARDIN                         /00639301/</medicinalproduct>
        <drugdosagetext>4 UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101023</drugenddate>
        <drugtreatmentduration>211</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRO-DUR</medicinalproduct>
        <drugdosagetext>200 A?G, UNK</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DORMICUM                           /00036201/</medicinalproduct>
        <drugdosagetext>7500 A?G, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100612</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTILIN</medicinalproduct>
        <drugdosagetext>600 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100623</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORECORMON</medicinalproduct>
        <drugdosagetext>8000 IU, 2 TIMES/WK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZALDIAR                            /01573601/</medicinalproduct>
        <drugdosagetext>7500 A?G, INTERMITTENT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZALDIAR                            /01573601/</medicinalproduct>
        <drugdosagetext>3250 A?G, INTERMITTENT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133624-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-GILEAD-2010-0033903</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugauthorizationnumb>021752</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090922</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREZISTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090922</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133625-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-GBRCT2010006454</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>CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANITUMUMAB</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>OESOPHAGEAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
        <drugtreatmentduration>148</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>OESOPHAGEAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
        <drugtreatmentduration>148</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>OESOPHAGEAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
        <drugtreatmentduration>148</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>OESOPHAGEAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
        <drugtreatmentduration>148</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>400 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE</medicinalproduct>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA                              /00142201/</medicinalproduct>
        <drugdosagetext>1.5 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugdosagetext>5 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>8 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100617</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE</medicinalproduct>
        <drugdosagetext>16 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPLICONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MST                                /00036302/</medicinalproduct>
        <drugdosagetext>30 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORAMPHENICOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIDOXINE HCL</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYMECYCLINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133626-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU274315</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANTINUCLEAR ANTIBODY INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORNEAL ABRASION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCERATIVE KERATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P113789</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1020322</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRIMONIDINE TARTRATE</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTEPREDNOL ETABONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133627-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GENENTECH-310255</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>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NEURITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133628-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100205</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GENENTECH-310491</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>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133629-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GENENTECH-310442</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>OLIGURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTIVASE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>32.5 ML, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>EMBOLIC STROKE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADICUT</medicinalproduct>
        <drugdosagetext>30 MG, BID</drugdosagetext>
        <drugindication>EMBOLIC STROKE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101117</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133630-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-310377</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133631-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GENENTECH-305825</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL SCAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>0.05 ML, UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090411</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>0.05 ML, UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>0.05 ML, UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>0.05 ML, UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090825</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>0.05 ML, UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100305</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>0.05 ML, UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100409</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>0.05 ML, UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GATIFLOXACIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133632-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HU-ABBOTT-10P-076-0680000-00</companynumb>
    <primarysource>
      <reportercountry>HUNGARY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100922</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEGALON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATOTOXICITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRITACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>4 TABS WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101007</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133633-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-GENENTECH-307130</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHRONIC MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133634-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-GENENTECH-304547</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100708</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROTEINURIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENSINA</medicinalproduct>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXODUS</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugindication>DIURETIC THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133635-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010005881</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133636-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080827</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GENENTECH-310411</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133637-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-10P-028-0686655-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAVIK</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020528</drugauthorizationnumb>
        <drugdosagetext>1 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090731</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAVIK</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020528</drugauthorizationnumb>
        <drugdosagetext>2 MG DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADACEL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMISIL + HYDROCORTISONE 1%</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>VOLTAREN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TECTA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT 200 TURBUHAKER</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>CIPRODEX DROPS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUVIRAL</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>PROFERRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLORIZIDE</medicinalproduct>
        <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>7133638-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101128</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7029781</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</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>SAIZEN</medicinalproduct>
        <drugauthorizationnumb>019764</drugauthorizationnumb>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100228</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133639-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-10P-028-0684650-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090817</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</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>ALTACE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133640-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-ABBOTT-10P-122-0687099-00</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL STOMA COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>GASTROINTESTINAL INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>POLYARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133641-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-10P-028-0684815-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100503</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133642-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0687310-00</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>ARTERIAL OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INGROWING NAIL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133643-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-GENENTECH-309515</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NYSTAGMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VESTIBULAR NEURONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>150 MG, Q2W</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INUVAIR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</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>MONTELUKAST</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100126</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133644-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080908</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GENENTECH-310408</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANGIOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133645-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080827</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GENENTECH-310414</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133646-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-AMGEN-BRASP2010000012</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133647-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-10P-087-0684904-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>46.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPLIN FOR INJECTION 3.75 MG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020011</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060816</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAK-700</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SILODOSIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPLERENONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOKALAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUP-4</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101104</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133648-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201041974NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEVICE DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>FREQUENCY: CONTINUOUS</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133649-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042092NA</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>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133650-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042070NA</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>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081116</drugenddate>
        <drugtreatmentduration>276</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133651-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DE-BAYER-201033260GPV</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECTOPIC PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY WITH CONTRACEPTIVE DEVICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090506</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133652-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100630</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201028805NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <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>YASMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133653-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BAYER-201047950GPV</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIDIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOCALCAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101004</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIURETIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101012</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UVEDOSE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOCALCAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101018</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101018</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101012</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101012</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133654-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-BAYER-2010-000047</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOBAY</medicinalproduct>
        <drugauthorizationnumb>020482</drugauthorizationnumb>
        <drugdosagetext>50 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133655-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042103NA</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133656-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BAYER-2010-000019</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100816</drugenddate>
        <drugtreatmentduration>94</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133657-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>ZA-BAYER-200934068GPV</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEVICE DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE EXPULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY WITH CONTRACEPTIVE DEVICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RUPTURED ECTOPIC PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 A?G (DAILY DOSE), CONT, INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 A?G (DAILY DOSE), CONT, INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 A?G (DAILY DOSE), CONT, INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133658-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAYER-201015862BYL</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY PSEUDOTUMOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOBAY</medicinalproduct>
        <drugauthorizationnumb>020482</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133659-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042053NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081101</drugenddate>
        <drugtreatmentduration>122</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133660-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>CA-BAYER-201042126NA</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEVICE DISLOCATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 A?G (DAILY DOSE), , INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133661-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042065NA</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>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133662-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091029</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>ZA-BAYER-200938025GPV</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</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>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091025</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133663-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042052NA</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133665-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100331</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>PL-BAYER-201017530GPV</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY WITH CONTRACEPTIVE DEVICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 A?G (DAILY DOSE), CONT, INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
        <drugtreatmentduration>1461</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133666-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100617</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201026385NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080501</drugenddate>
        <drugtreatmentduration>61</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugindication>ORAL CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OCELLA</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090501</drugenddate>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OCELLA</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugindication>ORAL CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSAID'S</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133667-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042081NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GALLBLADDER INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133668-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042056NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OCELLA</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133669-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042069NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080901</drugenddate>
        <drugtreatmentduration>426</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
        <drugtreatmentduration>487</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133670-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-BAYER-201021086LA</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>FLANAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133671-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042033NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133672-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>2</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>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY WITH CONTRACEPTIVE DEVICE</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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133673-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-000001</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 PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNEVIST</medicinalproduct>
        <drugbatchnumb>92559</drugbatchnumb>
        <drugauthorizationnumb>019596</drugauthorizationnumb>
        <drugdosagetext>15 ML, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101129</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133674-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071212</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-US-2006-018363</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA OF SKIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLIMARA</medicinalproduct>
        <drugauthorizationnumb>020375</drugauthorizationnumb>
        <drugdosagetext>.05 MG/D, CONT</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTROGENS CONJUGATED</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19930101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugdosagetext>DAILY DOSE 2.5 MG</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MENEST</medicinalproduct>
        <drugdosagetext>.625 MG, UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19950101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADERM</medicinalproduct>
        <drugdosagetext>0.05</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIPATCH</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990413</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960314</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFUDEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOBRADEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNCODEABLE ^UNCLASSIFIABLE^</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMIPRAMINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133675-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100615</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>PL-BAYER-201029307GPV</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEVICE DISLOCATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 A?G (DAILY DOSE), CONT, INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091005</drugenddate>
        <drugtreatmentduration>82</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133676-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201034327NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECTOPIC PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY WITH CONTRACEPTIVE DEVICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 A?G (DAILY DOSE), , INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100615</drugenddate>
        <drugtreatmentduration>457</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133677-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042028NA</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>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133678-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>JP-BAYER-201015831BYL</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SHOCK HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>8-HOUR BAYER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133679-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042064NA</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>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090403</drugenddate>
        <drugtreatmentduration>609</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133680-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042059NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
        <drugtreatmentduration>731</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133681-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042097NA</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>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133682-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042027NA</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>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133683-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DE-BAYER-2010-000077</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>VENOUS THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AIDA</medicinalproduct>
        <drugdosagetext>DAILY DOSE 1 DF</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133684-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>JP-BAYER-2010-000063</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>UPPER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugauthorizationnumb>021317</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY EMBOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugauthorizationnumb>021317</drugauthorizationnumb>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN POTASSIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY EMBOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN POTASSIUM</medicinalproduct>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133685-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042080NA</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>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081129</drugenddate>
        <drugtreatmentduration>444</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133686-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MYLANLABS-2010S1021405</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>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugauthorizationnumb>090868</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDICOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133687-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MYLANLABS-2010S1021415</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugauthorizationnumb>018487</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLENIL MODULITE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-CODAMOL</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>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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAMINE HCL</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>VITAMIN B COMPLEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133688-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MYLANLABS-2010S1021429</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACQUIRED DIAPHRAGMATIC EVENTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIAPHRAGMATIC PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALLORY-WEISS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE STIMULATION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugauthorizationnumb>075281</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CODEINE W/PARACETAMOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133689-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-ELI_LILLY_AND_COMPANY-ZA201012000364</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>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG MIX 75/25</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101114</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133690-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MYLANLABS-2010S1021560</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>JATROSOM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugauthorizationnumb>078626</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133691-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MYLANLABS-2010S1021560</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>JATROSOM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugauthorizationnumb>075577</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugauthorizationnumb>075577</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugauthorizationnumb>075577</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugauthorizationnumb>075577</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133692-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MYLANLABS-2010S1021560</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>JATROSOM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugauthorizationnumb>076540</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133693-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MYLANLABS-2010S1021560</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>JATROSOM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugauthorizationnumb>075207</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugauthorizationnumb>075207</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugauthorizationnumb>075207</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugauthorizationnumb>075207</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133694-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MYLANLABS-2010S1021567</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERAMMONAEMIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INBORN ERROR OF METABOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugauthorizationnumb>077254</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</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>2</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSPHENYTOIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133695-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MYLANLABS-2010S1021567</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERAMMONAEMIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INBORN ERROR OF METABOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugauthorizationnumb>077254</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</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>2</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSPHENYTOIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133696-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MYLANLABS-2010S1021632</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUETIAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVERDOSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAZODONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVERDOSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugauthorizationnumb>070317</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVERDOSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVERDOSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133697-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MYLANLABS-2010S1021632</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUETIAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVERDOSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAZODONE</medicinalproduct>
        <drugauthorizationnumb>090514</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVERDOSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVERDOSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVERDOSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133698-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MYLANLABS-2010S1021632</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF-MEDICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUETIAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVERDOSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAZODONE</medicinalproduct>
        <drugauthorizationnumb>071405</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVERDOSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVERDOSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVERDOSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133699-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MYLANLABS-2010S1021754</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>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>075969</drugauthorizationnumb>
        <drugdosagetext>USE STATED AS LONG-TERM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCET                             /01554201/</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133700-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MYLANLABS-2010S1021754</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>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>075973</drugauthorizationnumb>
        <drugdosagetext>USE STATED AS LONG-TERM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCET                             /01554201/</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133701-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MYLANLABS-2010S1021769</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>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTINUOUS HAEMODIAFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRONTOTEMPORAL DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERAMMONAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugdosagetext>125 X 500MG TABLETS; TOTAL DOSE }1000 MG/KG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTENTIONAL OVERDOSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugauthorizationnumb>074046</drugauthorizationnumb>
        <drugindication>INTENTIONAL OVERDOSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIAPRIDE</medicinalproduct>
        <drugindication>INTENTIONAL OVERDOSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133702-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MYLANLABS-2010S1021769</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>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugdosagetext>125 X 500MG TABLETS; TOTAL DOSE }1000 MG/KG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTENTIONAL OVERDOSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugauthorizationnumb>074215</drugauthorizationnumb>
        <drugindication>INTENTIONAL OVERDOSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIAPRIDE</medicinalproduct>
        <drugindication>INTENTIONAL OVERDOSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133703-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-AMGEN-ITASP2010006127</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>660 A?G, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
        <drugtreatmentduration>198</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANEX</medicinalproduct>
        <drugdosagetext>500 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101106</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133704-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU424009</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>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>330 A?G, UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100209</drugenddate>
        <drugtreatmentduration>239</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROID NOS</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090309</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133705-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100114</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006898</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>10 A?G/KG, UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
        <drugtreatmentduration>177</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND HYDROCODONE BITARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>88 A?G, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133706-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100602</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006982</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BRAIN NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>4 A?G/KG, UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100708</drugenddate>
        <drugtreatmentduration>154</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133707-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-10P-167-0687472-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133708-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100511</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RANBAXY-2010US-33787</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TORTICOLLIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
        <drugbatchnumb>1932819</drugbatchnumb>
        <drugauthorizationnumb>090183</drugauthorizationnumb>
        <drugdosagetext>5 ML, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER-AIRWAY COUGH SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090928</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
        <drugauthorizationnumb>090183</drugauthorizationnumb>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133709-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-QUU423116</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>LYOPHILIZED 50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070706</drugenddate>
        <drugtreatmentduration>358</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>LYOPHILIZED 25 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080627</drugenddate>
        <drugtreatmentduration>351</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100528</drugenddate>
        <drugtreatmentduration>694</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100618</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugdosagetext>35 MG, QWK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100629</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NU LOTAN</medicinalproduct>
        <drugdosagetext>3 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100629</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050219</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAVELMIN                          /00517301/</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>VERTIGO</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070626</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070511</drugenddate>
        <drugtreatmentduration>1060</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070906</drugenddate>
        <drugtreatmentduration>220</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANVITAN                           /00466101/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHADOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071026</drugenddate>
        <drugtreatmentduration>124</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMEDIN                          /00176001/</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071026</drugenddate>
        <drugtreatmentduration>124</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAGAMET                            /00397401/</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133710-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-AMGEN-IRLSP2010006877</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIAC AMYLOIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC TAMPONADE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR NECROSIS FACTOR RECEPTOR-ASSOCIATED PERIODIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>20MG / 15MG ALTERNATE DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TUMOUR NECROSIS FACTOR RECEPTOR-ASSOCIATED PERIODIC SYNDROME</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANAKINUMAB</medicinalproduct>
        <drugdosagetext>150 MG Q4W THEN Q2W</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TUMOUR NECROSIS FACTOR RECEPTOR-ASSOCIATED PERIODIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVELAMER</medicinalproduct>
        <drugdosagetext>800 MG, UNK</drugdosagetext>
        <drugindication>RENAL OSTEODYSTROPHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFACALCIDOL</medicinalproduct>
        <drugdosagetext>0.25 UG, UNK</drugdosagetext>
        <drugindication>RENAL OSTEODYSTROPHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREGABALIN</medicinalproduct>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>20 MG, 2X/DAY</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133711-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW06156</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>614</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>86.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091101</drugenddate>
        <drugtreatmentduration>112</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091101</drugenddate>
        <drugtreatmentduration>112</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091101</drugenddate>
        <drugtreatmentduration>112</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>100-400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>100-400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>100-400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19770101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugdosagetext>500 MG (4 TABS PER DAY 125MG)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080714</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE AND METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080714</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133712-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-JPNSP2010005241</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GASTRIC CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPH NODE TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYCOBACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091101</drugenddate>
        <drugtreatmentduration>243</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2X/WEEK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100915</drugenddate>
        <drugtreatmentduration>318</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugdosagetext>6 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugdosagetext>8 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugdosagetext>6 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090514</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090624</drugenddate>
        <drugtreatmentduration>60</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133713-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2009BI023257</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMYOTROPHIC LATERAL SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133714-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI008426</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>CEREBELLAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTYNIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>PERIPHERAL VASCULAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENABLEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO 5/325</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100622</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133715-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-BIOGENIDEC-2010BI014726</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IMMUNE RECONSTITUTION SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <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>20071210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100204</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133716-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>GB-BIOGENIDEC-2010BI016274</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>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100412</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133717-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI019477</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>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPH NODE PAIN</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>20071130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133718-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BIOGENIDEC-2010BI020897</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>CENTRAL NERVOUS SYSTEM LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SECONDARY PROGRESSIVE MULTIPLE SCLEROSIS</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>20090401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091201</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133719-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI027051</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>107</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS FULMINANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIITH NERVE PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugindication>MUSCLE SPASMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugindication>MUSCLE SPASMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133720-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI028175</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <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>20070227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100722</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugindication>VERTIGO</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANABIS</medicinalproduct>
        <drugindication>MUSCLE SPASTICITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANABIS</medicinalproduct>
        <drugindication>VERTIGO</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>4-AP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133721-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI028550</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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NEURITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133722-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI030057</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>CELLULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100715</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NALTREXONE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METROGEL</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAALOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVENTIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN XL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133723-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-BIOGENIDEC-2010BI032570</companynumb>
    <primarysource>
      <reportercountry>POLAND</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>CONTUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133724-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI033926</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>IMMUNE RECONSTITUTION SYNDROME</reactionmeddrapt>
      </reaction>
      <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>20070725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugindication>TRIGEMINAL NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
        <drugindication>TRIGEMINAL NEURALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133725-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-BIOGENIDEC-2010BI036047</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</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>CENTRAL NERVOUS SYSTEM LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS RELAPSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100301</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROID (NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133726-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BIOGENIDEC-2010BI036512</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>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-HODGKIN'S LYMPHOMA STAGE III</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SECONDARY HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080415</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugindication>TRIGEMINAL NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133727-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CZ-BIOGENIDEC-2010BI037087</companynumb>
    <primarysource>
      <reportercountry>CZECH REPUBLIC</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>BRAIN CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBARACHNOID HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugbatchnumb>100089B</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090820</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREGABALIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081031</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091016</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081031</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRIZOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080707</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133728-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI037640</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>COLONIC STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091211</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133729-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI037849</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>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071204</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133730-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI037882</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>102</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA STAPHYLOCOCCAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100316</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133731-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI039413</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>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070605</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133732-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI040867</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>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040205</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133733-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041110</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>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100713</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133734-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041325</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>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</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>20080722</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133735-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041329</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>78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DEATH</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>20100513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100923</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133736-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041332</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>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</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>20100916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN CR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</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>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133737-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041337</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>ENDOMETRIOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133738-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BIOGENIDEC-2010BI041448</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALIGNANT MELANOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133739-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041456</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080911</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133740-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041463</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090520</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133741-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041464</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>GENERAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080828</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133742-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2009BI039570</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>81</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER STAGE I</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUMS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPY (NOS)</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133743-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI010289</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>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32109</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100316</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133744-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI014124</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>43</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING DRUNK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAND FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONTROL OF LEGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICTURITION URGENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNDERWEIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011201</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>7133745-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI021462</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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONTROL OF LEGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060706</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133746-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI027529</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>ANAESTHETIC COMPLICATION NEUROLOGICAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040102</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133747-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI028950</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>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091216</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133748-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI031347</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>
      <patientweight>74</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERONEAL NERVE PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL MENINGIOMA BENIGN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND TREATMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040213</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133749-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI031383</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>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE NODULE</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>19981211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050713</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS (NOS)</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133750-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI031886</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133751-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BIOGENIDEC-2010BI034312</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>72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PUSTULAR PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090119</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133752-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI037774</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>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32124</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133753-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI039346</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>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133754-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI039458</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PITUITARY ENLARGEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>R01002</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133755-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI039464</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>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32128</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</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>19990801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133756-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI039572</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>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100625</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133757-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BIOGENIDEC-2010BI039831</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>ACUTE PROMYELOCYTIC LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133758-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI039911</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>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32124</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133759-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI040182</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>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090507</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133760-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-BIOGENIDEC-2010BI041339</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133761-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-BIOGENIDEC-2010BI041443</companynumb>
    <primarysource>
      <reportercountry>TURKEY</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100809</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133762-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041479</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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090311</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133763-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041481</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>CEREBROVASCULAR ACCIDENT</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>P32124</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133764-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041485</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>HYSTERECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32135</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100511</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133765-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041644</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>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE</medicinalproduct>
        <drugindication>BLADDER DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugindication>ANTIDEPRESSANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DISLOCATION OF VERTEBRA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133766-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041693</companynumb>
    <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>7133767-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041713</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>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050322</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133768-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041801</companynumb>
    <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>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133769-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI002988</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>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060703</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133770-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2008BI001470</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>ENDOMETRIAL CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL CANCER STAGE I</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>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133771-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI017668</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>86</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVIGILANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100823</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133772-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI018799</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>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENITAL HERPES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL HERPES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133773-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI021786</companynumb>
    <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>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070507</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133774-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI025079</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>CHEST PAIN</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>20081022</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133775-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI029002</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>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NEURITIS</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>20100526</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133776-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI031037</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>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugbatchnumb>P68101</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100728</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133777-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI033827</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>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070321</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133778-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI034973</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090310</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100706</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133779-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI035143</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091230</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133780-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI036231</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>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugbatchnumb>P68103</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101005</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133781-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI036295</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>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133782-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI036612</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>CHEMICAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133783-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI037382</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>NECK MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</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>20100517</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133784-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI037718</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>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100716</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133785-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI039449</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>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>20071012</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133786-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI040120</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>JC VIRUS TEST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080610</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133787-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041060</companynumb>
    <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>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</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>20091124</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133788-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041087</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>BLADDER HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080708</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133789-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041136</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOTENSIN CONVERTING ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101025</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133790-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041335</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>TRACHEOBRONCHITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100318</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133791-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041525</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>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090520</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMBASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133792-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041672</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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT RANGE OF MOTION DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133793-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041675</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>DIZZINESS</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>20101123</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133794-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041679</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100831</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133795-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041680</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133796-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041685</companynumb>
    <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>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100215</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133797-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041687</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>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100305</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133798-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041688</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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100414</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133799-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041696</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>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070716</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133800-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041698</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>CARDIAC FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133801-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041702</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>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090923</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133802-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041703</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133803-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041706</companynumb>
    <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>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100917</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133804-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041707</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 SPECIFIC ANTIBODY PRESENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133805-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041709</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100721</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133806-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041714</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>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090922</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133807-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041717</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>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133808-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041719</companynumb>
    <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>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070110</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133809-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041723</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081219</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071022</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133810-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041730</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>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133811-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041733</companynumb>
    <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>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070322</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133812-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041737</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>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101112</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133813-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041739</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE ALLERGIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DEFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091218</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133814-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041741</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>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100820</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133815-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041743</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>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100304</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070514</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133816-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041745</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>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133817-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041749</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101119</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133818-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041750</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>FALL</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>20100914</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133819-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041753</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>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133820-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041762</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133821-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041766</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133822-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041767</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>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070725</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010324</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133823-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041806</companynumb>
    <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>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100713</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133824-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041815</companynumb>
    <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>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091107</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133825-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041818</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133826-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041821</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 INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091222</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133827-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041823</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>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100708</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133828-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041827</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>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090924</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133829-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041830</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091013</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080731</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133830-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041831</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>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100813</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133831-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041832</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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070731</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133832-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041833</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>MULTIPLE ALLERGIES</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>20070907</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133833-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041837</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100324</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133834-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041841</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090910</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133835-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041842</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <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>20100218</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031222</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133836-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041854</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>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070523</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133837-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041861</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>GAIT DISTURBANCE</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>20080930</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133838-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041877</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>NAUSEA</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>20101001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133839-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041892</companynumb>
    <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>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080506</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133840-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041900</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>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133841-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041908</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN UPPER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133842-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041914</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>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugbatchnumb>P68101</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133843-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041918</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>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090203</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133844-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041925</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>MUSCLE SPASTICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090609</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133845-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041933</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</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091230</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133846-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041937</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>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090113</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133847-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100825</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI030474</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>INJECTION SITE EXTRAVASATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32129</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133848-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041541</companynumb>
    <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 COLD</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133849-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041871</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>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32121</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133850-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041876</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>FEELING COLD</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>19950813</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133851-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041882</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>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32132</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080411</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133852-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091204</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2009BI040101</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>COLOUR BLINDNESS ACQUIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</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>20071003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090715</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133853-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2009BI040240</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>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE ALLERGIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090828</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133854-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2010BI004851</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>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</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>20091218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133855-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010156685</companynumb>
    <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>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133856-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2010093019</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>162</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
        <drugdosagetext>3 UG, 1X/DAY, 1 DROP IN EACH EYE</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070423</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
        <drugindication>INTRAOCULAR PRESSURE INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIMOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133857-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090415</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-CELGENEUS-056-21880-10110893</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080515</drugenddate>
        <drugtreatmentduration>396</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080515</drugenddate>
        <drugtreatmentduration>396</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133858-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-CELGENEUS-062-21880-10091789</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISCITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133859-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-015790-10</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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION DURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MUCINEX</medicinalproduct>
        <drugbatchnumb>WO0074291</drugbatchnumb>
        <drugdosagetext>TAKEN FOR A LITTLE OVER A WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MUCINEX</medicinalproduct>
        <drugbatchnumb>WO0074291</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MUCINEX DM</medicinalproduct>
        <drugbatchnumb>WO00448741</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133860-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-12837BP</companynumb>
    <primarysource>
      <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>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>003004A,9D1018</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133861-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-257541USA</companynumb>
    <primarysource>
      <reportercountry>UNITED 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>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugauthorizationnumb>020622</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133862-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100416</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RANBAXY-2010US-36058</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC URAEMIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA CYTOMEGALOVIRAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GANCICLOVIR</medicinalproduct>
        <drugbatchnumb>1889555</drugbatchnumb>
        <drugauthorizationnumb>076457</drugauthorizationnumb>
        <drugdosagetext>500 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARIBAVIR (PLACEBO)</medicinalproduct>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
        <drugtreatmentduration>99</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACYCLOVIR SODIUM</medicinalproduct>
        <drugdosagetext>400.000000 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TRANSPLANT REJECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TRANSPLANT REJECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANTIFUNGAL PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERGLYCAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133863-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2009253532</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>011839</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>011839</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>011839</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>0.625 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugdosagetext>0.5 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTROGENS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133864-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-PFIZER INC-2010133710</companynumb>
    <primarysource>
      <reportercountry>FINLAND</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>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</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>20100825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAPAM</medicinalproduct>
        <drugdosagetext>60MG DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugdosagetext>100 MG ONCE DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BURANA</medicinalproduct>
        <drugdosagetext>800 MG THREE TIMES DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL CITRATE</medicinalproduct>
        <drugdosagetext>50 MG, AS NEEDED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANADOL</medicinalproduct>
        <drugdosagetext>1G 1-3 TIMES DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100525</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133865-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2008010543</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>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
        <drugdosagetext>3 UG, ONE DROP IN EACH EYE, UNSPECIFIED FREQUENCY</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133866-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010126998</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>81.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST HERPETIC NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100910</drugenddate>
        <drugtreatmentduration>44</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100605</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133867-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CZ-PFIZER INC-2010144582</companynumb>
    <primarysource>
      <reportercountry>CZECH REPUBLIC</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>AMYLOIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugauthorizationnumb>007073</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133868-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-PFIZER INC-2010150490</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BILIARY NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
        <drugauthorizationnumb>021110</drugauthorizationnumb>
        <drugdosagetext>2 MG EVERY 24 HOURS ALTERNATING WITH 3 MG TWO DAYS A WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSANT DRUG THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
        <drugauthorizationnumb>021110</drugauthorizationnumb>
        <drugdosagetext>7 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
        <drugauthorizationnumb>021110</drugauthorizationnumb>
        <drugdosagetext>2 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
        <drugindication>IMMUNOSUPPRESSANT DRUG THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101025</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugindication>IMMUNOSUPPRESSANT DRUG THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLIC ACID</medicinalproduct>
        <drugdosagetext>360 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101025</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133869-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010136972</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST HERPETIC NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100802</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101011</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARASENA A</medicinalproduct>
        <drugdosagetext>300 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANTIVIRAL TREATMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100612</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugdosagetext>1000 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIVIRAL TREATMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100622</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARASENA A</medicinalproduct>
        <drugdosagetext>0.5 G, 2X/DAY</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100625</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAIXAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100622</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBAMIPIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100622</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBAMIPIDE</medicinalproduct>
        <drugdosagetext>UNK 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100927</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RINDERON-V</medicinalproduct>
        <drugdosagetext>1 G, 1X/DAY</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PRURITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100628</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN</medicinalproduct>
        <drugdosagetext>UNK 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100727</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN</medicinalproduct>
        <drugdosagetext>UNK 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100927</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>75 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100727</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUVELA</medicinalproduct>
        <drugdosagetext>50 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100927</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RINDERON-VG</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ECZEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100920</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOCOID</medicinalproduct>
        <drugdosagetext>0.5 G, 1X/DAY</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENIVACE</medicinalproduct>
        <drugdosagetext>UNK 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEVALOTIN</medicinalproduct>
        <drugdosagetext>UNK 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133870-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010138293</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CERVICOBRACHIAL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>MUSCULOSKELETAL STIFFNESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CERVICOBRACHIAL SYNDROME</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMIDAPRIL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLETAL</medicinalproduct>
        <drugdosagetext>100 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133871-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13012BP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS HCT</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021162</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133873-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-RANBAXY-2010RR-39762</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugauthorizationnumb>076285</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133874-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-RANBAXY-2010RR-39764</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugauthorizationnumb>076285</drugauthorizationnumb>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133875-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-RANBAXY-2010RR-39759</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugauthorizationnumb>076445</drugauthorizationnumb>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133876-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-RANBAXY-2010RR-39776</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugauthorizationnumb>076285</drugauthorizationnumb>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133877-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-RANBAXY-2010RR-39756</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugauthorizationnumb>076285</drugauthorizationnumb>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133878-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-RANBAXY-2010RR-39763</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugauthorizationnumb>076285</drugauthorizationnumb>
        <drugdosagetext>20 MG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133879-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-RANBAXY-2010RR-39760</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugauthorizationnumb>076285</drugauthorizationnumb>
        <drugdosagetext>20 MG, BID</drugdosagetext>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133880-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-RANBAXY-2010RR-39761</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugauthorizationnumb>076445</drugauthorizationnumb>
        <drugdosagetext>40 MG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133881-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RANBAXY-2010RR-39862</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>075747</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUONEB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133882-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-RANBAXY-2010RR-39127</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFUROXIME</medicinalproduct>
        <drugbatchnumb>2115060</drugbatchnumb>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFUROXIME</medicinalproduct>
        <drugdosagetext>250 MG, QID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFUROXIME</medicinalproduct>
        <drugdosagetext>250 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>600 MG, QD</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISIHEXAL</medicinalproduct>
        <drugdosagetext>5 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTEX TABLETS</medicinalproduct>
        <drugdosagetext>UNK MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTEX PROLONGED RELEASE TABLETS</medicinalproduct>
        <drugdosagetext>UNK MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
        <drugdosagetext>250 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>12.5 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE AND FOLIC ACID</medicinalproduct>
        <drugdosagetext>7.5 MG, 1/WEEK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEVANATE 70MG</medicinalproduct>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECORTIN H 5MG</medicinalproduct>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUTHYROX 50UG</medicinalproduct>
        <drugdosagetext>UNK UG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugdosagetext>125 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUILONUM RET. 225MG</medicinalproduct>
        <drugdosagetext>225 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE-CT 40MG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROSANOL</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM AND VITAMIN D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133888-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201030646NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080601</drugenddate>
        <drugtreatmentduration>61</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OCELLA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080601</drugenddate>
        <drugtreatmentduration>61</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOESTRIN 1.5/30</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETHINYL ESTRADIOL AND NORETHINDRONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICROGESTIN 1.5/30</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVORA 0.15/30-21</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070323</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HYDROCHLORIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070323</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133889-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201031209NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BILE DUCT STONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080201</drugenddate>
        <drugtreatmentduration>487</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133891-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100831</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201028694NA</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>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020701</drugenddate>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugindication>MENSTRUAL CYCLE MANAGEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TPN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL ES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133892-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201037460NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY WITH CONTRACEPTIVE DEVICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>FREQUENCY CONTINUOUS</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133893-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201027578NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
        <drugtreatmentduration>731</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSAIDS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
        <drugtreatmentduration>3653</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPITOL</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TREXIMOT</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133894-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201035197NA</companynumb>
    <primarysource>
      <reportercountry>UKRAINE</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090601</drugenddate>
        <drugtreatmentduration>122</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133895-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201019933NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090309</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNCODEABLE ^UNCLASSIFIABLE^</medicinalproduct>
        <drugdosagetext>DAILY DOSE 500 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>DAILY DOSE 50 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE 150 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXALT</medicinalproduct>
        <drugdosagetext>DAILY DOSE 10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
        <drugdosagetext>1  CAPSULE QD IN AM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DYSPNOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>CAPSULE DELAYED QD BEFORE MEAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASTELIN</medicinalproduct>
        <drugdosagetext>2 SPRAYS IN EACH NOSTRIL TWICE QD.</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENTYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133896-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201029022NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BILIARY COLIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIARY DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISION SITE INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENSTRUAL CYCLE MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090901</drugenddate>
        <drugtreatmentduration>1004</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXAIR</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133897-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201047845GPV</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTAVIS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSTACYCLIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CHANNEL BLOCKERS</medicinalproduct>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133898-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201037452NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY WITH CONTRACEPTIVE DEVICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>FREQUENCY CONTINUOUS</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100923</drugenddate>
        <drugtreatmentduration>304</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133899-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201023198NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AXILLARY VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT CREPITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAGET-SCHROETTER SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RAYNAUD'S PHENOMENON</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBCLAVIAN VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THORACIC OUTLET SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugbatchnumb>74030A</drugbatchnumb>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080601</drugenddate>
        <drugtreatmentduration>913</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133900-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201016262NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACTIVATED PROTEIN C RESISTANCE TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
        <drugtreatmentduration>1035</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133901-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201022353NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090401</drugenddate>
        <drugtreatmentduration>1826</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060331</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133902-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201022719BCC</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>RID LICE KILLING SHAMPOO AND CONDITION</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101011</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133903-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101006</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201022345BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>220 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101005</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133904-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100611</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201010768NA</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>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091001</drugenddate>
        <drugtreatmentduration>548</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OCELLA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXCEDRIN (MIGRAINE)</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133905-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201030660NA</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>BILE DUCT OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE LEIOMYOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OCELLA</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>MAXALT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZEGERID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENTERMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KAPIDEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133906-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201038707NA</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>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OCELLA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133907-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201039818NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090109</drugenddate>
        <drugtreatmentduration>183</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133908-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201024397NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
        <drugtreatmentduration>1461</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071219</drugenddate>
        <drugtreatmentduration>917</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OCELLA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081216</drugstartdate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OCELLA</medicinalproduct>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OVCON-35 - 28</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050417</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVORA 0.15/30-28</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091213</drugenddate>
        <drugtreatmentduration>309</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133909-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201037390NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY WITH CONTRACEPTIVE DEVICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>62266B</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>FREQUENCY CONTINUOUS</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101012</drugenddate>
        <drugtreatmentduration>1081</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133910-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201033324NA</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081101</drugenddate>
        <drugtreatmentduration>1187</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>CENTRUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133911-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201025745NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133912-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-000271</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>HANGOVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN SODIUM LIQUID GEL CAPSULES</medicinalproduct>
        <drugdosagetext>2640 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN SODIUM LIQUID GEL CAPSULES</medicinalproduct>
        <drugdosagetext>440 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101123</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133913-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101029</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201039811NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DISEASE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090301</drugenddate>
        <drugtreatmentduration>122</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133914-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100816</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BY-BAYER-201036174GPV</companynumb>
    <primarysource>
      <reportercountry>BELARUS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>UTERINE LEIOMYOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 A?G (DAILY DOSE), CONT, INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100714</drugenddate>
        <drugtreatmentduration>152</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133915-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BAYER-201047917GPV</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>EXTAVIA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100225</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133916-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201021408NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040430</drugenddate>
        <drugtreatmentduration>670</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133917-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201021623NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090601</drugenddate>
        <drugtreatmentduration>730</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090601</drugenddate>
        <drugtreatmentduration>731</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugindication>MULTIPLE ALLERGIES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID PREPARATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133920-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100908</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200941440NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BILE DUCT STONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091001</drugenddate>
        <drugtreatmentduration>122</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugdosagetext>60 MG (DAILY DOSE), BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090728</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
        <drugdosagetext>15 MG (DAILY DOSE), QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090728</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORETHINDRONE</medicinalproduct>
        <drugdosagetext>LAST REFILL: 29-MAR-2010</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ CODEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPIRONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUCRALFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133921-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100930</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201038259NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133922-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201038233NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY WITH CONTRACEPTIVE DEVICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>FREQUENCY CONTINUOUS</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081031</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133923-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201028480NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</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>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
        <drugtreatmentduration>1461</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXALT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1 TABLET AS NEEDED</drugdosagetext>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
        <drugindication>INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133924-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201023275NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MULTIPLE INJURIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OCELLA</medicinalproduct>
        <drugbatchnumb>84079A</drugbatchnumb>
        <drugdosagetext>1 TABLET/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL-XR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133925-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200943151NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
        <drugtreatmentduration>2192</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OCELLA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>200 MG (DAILY DOSE), PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUDAFED S.A.</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE ALLERGIES</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugdosagetext>25 MG (DAILY DOSE), PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE ALLERGIES</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNCODEABLE ^UNCLASSIFIABLE^</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNCODEABLE ^UNCLASSIFIABLE^</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>20 MG (DAILY DOSE), QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133926-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100930</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201037952NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>PFS: 2006, MEDICAL RECORDS: 2005.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE</medicinalproduct>
        <drugdosagetext>PHARMACY RECORDS: DISPENSED IN JUL 2005 , FEB 2008, JUL 2009 AND MAY 2010;</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIVORA-21</medicinalproduct>
        <drugdosagetext>PHARMACY RECORDS: NOV 2008</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133927-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201030646NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080601</drugenddate>
        <drugtreatmentduration>61</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OCELLA</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080601</drugenddate>
        <drugtreatmentduration>61</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOESTRIN 1.5/30</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETHINYL ESTRADIOL AND NORETHINDRONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICROGESTIN 1.5/30</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVORA 0.15/30-21</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070323</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HYDROCHLORIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070323</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133929-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BAYER-201047634GPV</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FOCAL NODULAR HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 A?G (DAILY DOSE), CONT, INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133930-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-BAYER-201021185LA</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BREECH PRESENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL DRUGS AFFECTING FOETUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICROVLAR</medicinalproduct>
        <drugauthorizationnumb>018668</drugauthorizationnumb>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133931-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201039186NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COAGULOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090901</drugenddate>
        <drugtreatmentduration>61</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COAGULOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090901</drugenddate>
        <drugtreatmentduration>61</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133932-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101007</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201036682NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DISEASE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
        <drugtreatmentduration>1370</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133933-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200938308NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080801</drugenddate>
        <drugtreatmentduration>61</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081101</drugenddate>
        <drugtreatmentduration>61</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133934-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201031347NA</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>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEEDLE ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>ZA9211A</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010827</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133935-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201020534NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEPTIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>3-20 MG-MCG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>GASTRIC PH DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugindication>GASTRIC PH DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN</medicinalproduct>
        <drugindication>BACTERIAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZACLIN</medicinalproduct>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM</medicinalproduct>
        <drugindication>BACTERIAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMFETAMINE</medicinalproduct>
        <drugindication>FATIGUE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE HCL AND CODEINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
        <drugdosagetext>10 MG IN 8 ML</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugdosagetext>25 MG IN 9 ML</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INAPSINE</medicinalproduct>
        <drugdosagetext>1 MG IN 4 ML</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133936-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100630</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201028792NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BREAST MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE LEIOMYOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>1 TABLET PER DAY. 12 SAMPLES RECEIVED FROM PHYSICIAN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080501</drugenddate>
        <drugtreatmentduration>487</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OCELLA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugdosagetext>1 TALBET EVERY 8 HOURS IF NEEDED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133937-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-BAYER-201021173LA</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY ON ORAL CONTRACEPTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE LABOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICROVLAR</medicinalproduct>
        <drugauthorizationnumb>018782</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133938-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100611</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201010768NA</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>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091001</drugenddate>
        <drugtreatmentduration>548</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OCELLA</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXCEDRIN (MIGRAINE)</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133939-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100930</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201038340NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OCELLA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133941-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100908</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200941440NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091001</drugenddate>
        <drugtreatmentduration>122</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugdosagetext>60 MG (DAILY DOSE), BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090728</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
        <drugdosagetext>15 MG (DAILY DOSE), QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090728</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORETHINDRONE</medicinalproduct>
        <drugdosagetext>LAST REFILL: 29-MAR-2010</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ CODEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPIRONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUCRALFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133942-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201035197NA</companynumb>
    <primarysource>
      <reportercountry>UKRAINE</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090601</drugenddate>
        <drugtreatmentduration>122</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133943-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201020430NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER-AIRWAY COUGH SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>AS USED DOSE: UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080418</drugenddate>
        <drugtreatmentduration>204</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>CLARINEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVENTIL-HFA</medicinalproduct>
        <drugdosagetext>1-2 PUFFS EVERY 4-6 HOURS AS NEEDED</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133944-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201038654NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY WITH CONTRACEPTIVE DEVICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU00358</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>FREQUENCY CONTINUOUS</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100319</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133945-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100903</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201011735NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPLASTIC CHOLECYSTOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
        <drugtreatmentduration>1095</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
        <drugtreatmentduration>2192</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OCELLA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFADROXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNCODEABLE ^UNCLASSIFIABLE^</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUPIROCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133946-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201027257NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080801</drugenddate>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133947-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201047958GPV</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTAVIS</medicinalproduct>
        <drugbatchnumb>01074A</drugbatchnumb>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>FIRST SHIPMENT 15 OCT 2007, LAST SHIPMENT 29 OCT 2010</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133948-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201039980NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEVICE EXPULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TV002P4</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100808</drugenddate>
        <drugtreatmentduration>62</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133949-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201039186NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COAGULOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090901</drugenddate>
        <drugtreatmentduration>61</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COAGULOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090901</drugenddate>
        <drugtreatmentduration>61</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133950-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RANBAXY-2010US-39620</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugauthorizationnumb>077974</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133951-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RANBAXY-2010US-39821</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugauthorizationnumb>076386</drugauthorizationnumb>
        <drugdosagetext>400 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TINEA VERSICOLOUR</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133954-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101121</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101108862</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMPONI</medicinalproduct>
        <drugbatchnumb>02324784</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMPONI</medicinalproduct>
        <drugbatchnumb>02324784</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133955-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13318BP</companynumb>
    <primarysource>
      <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>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133956-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13401BP</companynumb>
    <primarysource>
      <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>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENERGY INCREASED</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>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133957-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13478BP</companynumb>
    <primarysource>
      <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>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133960-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-EISAI INC.-E2020-08091-SPO-JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>93</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>37</patientweight>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugauthorizationnumb>020690</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101014</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TULOBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROHYPNOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADOAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>YOKU-KAN-SAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HALLUCINATION, VISUAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133961-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101121</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-JNJFOC-20101108608</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</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>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133962-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101108912</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>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133963-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101108175</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CSF CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKULL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DELAYED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0410561</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENAZPRINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARIJUANA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133964-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101107690</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>PRODUCT ADHESION ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0919339</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0919339</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133965-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101107839</companynumb>
    <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 ADHESION ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133966-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101108183</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.26</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT ADHESION ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>2 X 100 MCG PATCHES, NDC-0781-7114-55</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugdosagetext>NDC-0781-7114-55</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugdosagetext>100 MCG X 2 PATCHES = 200 MCG, NDC-0781-7244-55</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugdosagetext>1-3 TABLETS EVERY 6 HOURS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAKTHROUGH PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133967-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010156279</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>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SALAZOPYRIN</medicinalproduct>
        <drugauthorizationnumb>007073</drugauthorizationnumb>
        <drugdosagetext>1500 MG PER DAY</drugdosagetext>
        <drugindication>GASTROENTERITIS RADIATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101013</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SALAZOPYRIN</medicinalproduct>
        <drugauthorizationnumb>007073</drugauthorizationnumb>
        <drugdosagetext>1000 MG PER DAY</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101013</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133968-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010144211</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>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZULFIDINE</medicinalproduct>
        <drugauthorizationnumb>007073</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133969-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2010157460</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>PANCREATIC FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS NECROTISING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAHOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133973-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101200007</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL DRUGS AFFECTING FOETUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRISOMY 21</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEMASOLE</medicinalproduct>
        <drugauthorizationnumb>017481</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRON SUPPLEMENTS</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133974-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101109152</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 EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRA-UTERINE DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE LABOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEMASOLE</medicinalproduct>
        <drugauthorizationnumb>017481</drugauthorizationnumb>
        <drugdosagetext>SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HOOKWORM INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRON SUPPLEMENTS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MEDICAL DIET</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133975-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101108012</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 EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRA-UTERINE DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE LABOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEMASOLE</medicinalproduct>
        <drugauthorizationnumb>017481</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HOOKWORM INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRON SUPPLEMENTS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MEDICAL DIET</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133976-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101200008</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEMASOLE</medicinalproduct>
        <drugauthorizationnumb>017481</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRON SUPPLEMENTS</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133979-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101200009</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MATERNAL DRUGS AFFECTING FOETUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYDACTYLY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEMASOLE</medicinalproduct>
        <drugauthorizationnumb>017481</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRON SUPPLEMENTS</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133980-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101200815</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MATERNAL DRUGS AFFECTING FOETUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE CONGENITAL ABNORMALITIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEMASOLE</medicinalproduct>
        <drugauthorizationnumb>017481</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRON SUPPLEMENTS</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133981-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101200012</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CLEFT PALATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL DRUGS AFFECTING FOETUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEMASOLE</medicinalproduct>
        <drugauthorizationnumb>017481</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRON SUPPLEMENTS</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133982-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101200011</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL DRUGS AFFECTING FOETUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEMASOLE</medicinalproduct>
        <drugauthorizationnumb>017481</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRON SUPPLEMENTS</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133983-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-PFIZER INC-2010156252</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LARYNGOSPASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>300 MG, 1X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>200 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>75 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARTIA XT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133985-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101200098</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>HAEMOGLOBIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugdosagetext>DAY 1 OF EACH CYCLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IXABEPILONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE</medicinalproduct>
        <drugdosagetext>30 MINS PRIOR TO IXABEPILONE INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>30 MINS PRIOR TO IXABEPILONE INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133986-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101200099</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 HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugdosagetext>DAY 1 OF EACH CYCLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IXABEPILONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE</medicinalproduct>
        <drugdosagetext>30 MINS PRIOR TO IXABEPILONE INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>30 MINS PRIOR TO IXABEPILONE INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133987-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101200096</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>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugdosagetext>DAY 1 OF EACH CYCLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IXABEPILONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE</medicinalproduct>
        <drugdosagetext>30 MINS BEFORE IXABEPILONE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>30 MINS BEFORE IXABEPILONE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133988-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101200102</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>WHITE BLOOD CELL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugdosagetext>DAY 1 OF EACH CYCLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IXABEPILONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE</medicinalproduct>
        <drugdosagetext>30 MINS PRIOR TO IXABEPILONE INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>30 MINS PRIOR TO IXABEPILONE INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133989-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-SANOFI-AVENTIS-2010SA062071</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
        <drugauthorizationnumb>021379</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100826</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISIHEXAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100503</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100503</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100503</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE/VALSARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133990-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201007002062</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 OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A709633D</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A713108C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugtreatmentduration>122</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUONEB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM +VIT D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOLAZONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CATAPRES /00171102/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133991-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GENZYME-THYM-1002134</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>ACUTE GRAFT VERSUS HOST DISEASE IN SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAL SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>87.5 MG, ONCE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100511</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE SODIUM SUCCINATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100511</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPHENIRAMINE MALEATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100511</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100511</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM + SULFAMETHOXAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANTIFUNGAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100512</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101006</drugenddate>
        <drugtreatmentduration>141</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100526</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACICLOVIR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100603</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANTIFUNGAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100625</drugenddate>
        <drugtreatmentduration>51</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANTIFUNGAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100915</drugenddate>
        <drugtreatmentduration>82</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100518</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOTAL BODY IRRADIATION</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100514</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133992-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-ABBOTT-10P-066-0659354-00</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>38</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090708</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AUTOIMMUNE THYROIDITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133994-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101200104</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>WHITE BLOOD CELL COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugdosagetext>DAY 1 OF EACH CYCLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IXABEPILONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
        <drugdosagetext>30 MINS PRIOR TO IXABEPILONE INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>30 MINS PRIOR TO IXABEPILONE INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133995-6</safetyreportid>
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    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101200109</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>HAEMOGLOBIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugdosagetext>DAY 1 OF EACH CYCLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IXABEPILONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
        <drugdosagetext>30 MINS PRIOR TO IXABEPILONE INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>30 MINS PRIOR TO IXABEPILONE INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133996-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101200103</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>PERIPHERAL SENSORY NEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugdosagetext>DAY 1 OF EACH CYCLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IXABEPILONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
        <drugdosagetext>30 MINS PRIOR TO IXABEPILONE INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>30 MINS PRIOR TO IXABEPILONE INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133997-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101200975</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK LEFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEARFULNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <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>QUETIAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAZODONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAFFEINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133998-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13575BP</companynumb>
    <primarysource>
      <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>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7133999-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GENZYME-THYM-1002149</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>IDIOPATHIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090622</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134000-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-RANBAXY-2010R1-39820</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>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXCARBAZEPINE</medicinalproduct>
        <drugauthorizationnumb>078734</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PARTIAL SEIZURES</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134001-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-RANBAXY-2010RR-39755</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugauthorizationnumb>076445</drugauthorizationnumb>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134002-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-RANBAXY-2010RR-39777</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugauthorizationnumb>076285</drugauthorizationnumb>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134003-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-RANBAXY-2010RR-38437</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>LYMPHOCYTE STIMULATION TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBULOINTERSTITIAL NEPHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugauthorizationnumb>090283</drugauthorizationnumb>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANIPENEM/BETAMIPRON</medicinalproduct>
        <drugdosagetext>1 G, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GARENOXACIN</medicinalproduct>
        <drugdosagetext>400 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134004-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RANBAXY-2010RR-39893</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT RANGE OF MOTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>075747</drugauthorizationnumb>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugdosagetext>750 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOCALISED INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070829</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugdosagetext>750 MG, QD</drugdosagetext>
        <drugindication>THERMAL BURN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070906</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugdosagetext>750 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugdosagetext>750 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080807</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134005-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2010RR-36593</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugauthorizationnumb>076990</drugauthorizationnumb>
        <drugdosagetext>40 MG 1 IN 1 D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMILORIDE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLIZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYOSCINE HBR HYT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROPINIROLE</medicinalproduct>
        <drugdosagetext>250 MICROG</drugdosagetext>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134007-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101108610</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>
      <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>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134008-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101108390</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>20-35 MG/M2 MIXED IN 100 CC 5 % DEXTROSE WATER OVER ONE HOUR ON ON DAY ONE.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO LIVER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugdosagetext>20-35 MG/M2 MIXED IN 100 CC 5 % DEXTROSE WATER OVER ONE HOUR ON ON DAY ONE.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>100-125 MG/M2 IN NORMAL SALINE 250 ML</drugdosagetext>
        <drugadministrationroute>013</drugadministrationroute>
        <drugindication>METASTASES TO LIVER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>100-125 MG/M2 IN NORMAL SALINE 250 ML</drugdosagetext>
        <drugadministrationroute>013</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugdosagetext>DAY 1</drugdosagetext>
        <drugadministrationroute>013</drugadministrationroute>
        <drugindication>METASTASES TO LIVER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugdosagetext>DAY 1</drugdosagetext>
        <drugadministrationroute>013</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>DAY 1 PRIOR TO START OF CHEMOTHERAPY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO LIVER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>FOR 5 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>FOR 5 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>DAY 1 PRIOR TO START OF CHEMOTHERAPY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134009-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-SANOFI-AVENTIS-2010SA070447</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>021759</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134010-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-10P-062-0684247-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>51</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHIECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPHILUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA PRIMARY ATYPICAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134014-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-AMGEN-ESPSP2010006258</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>500 A?G, QWK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>THROMBOCYTOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100519</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134016-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-JNJFOC-20101200531</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LIVER TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134017-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-JNJFOC-20101200532</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LIVER TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134018-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-JNJFOC-20101200533</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LIVER TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134019-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-JNJFOC-20101200128</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LIVER TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134020-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-JNJFOC-20101200529</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LIVER TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134021-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-JNJFOC-20101200530</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LIVER TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134022-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-GENZYME-THYM-1002116</companynumb>
    <primarysource>
      <reportercountry>GREECE</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>HAEMORRHAGIC STROKE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>15 MG/KG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>APLASTIC ANAEMIA</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>6 MG/KG, QD</drugdosagetext>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
        <drugtreatmentduration>183</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>0.5 MG/KG, Q4W</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugdosagetext>2 MG/KG, QD</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS, CONCENTRATED</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>APLASTIC ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLATELETS, CONCENTRATED</medicinalproduct>
        <drugindication>APLASTIC ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugdosagetext>400 MCG/M2, 3X/W</drugdosagetext>
        <drugindication>APLASTIC ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOSYN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANTIBIOTIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
        <drugindication>ANTIBIOTIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
        <drugindication>ANTIFUNGAL TREATMENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134025-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-GENZYME-THYM-1002118</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</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>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSOAS ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALMONELLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>APLASTIC ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugindication>APLASTIC ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROID NOS</medicinalproduct>
        <drugindication>APLASTIC ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134028-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101108573</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GINGIVAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE ULCERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134029-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-JNJFOC-20101107351</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLECTOMY TOTAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134030-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101108322</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>99.79</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 3</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugdosagetext>SINCE 4 YEARS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 3</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugdosagetext>SINCE 4 YEARS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPINAL COLUMN STENOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 3</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>085055</drugauthorizationnumb>
        <drugdosagetext>SINCE 4 YEARS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugbatchnumb>A0403</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>SINCE 2 YEARS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MEDICAL DIET</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GLUCOSE TOLERANCE IMPAIRED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>SINCE 2000</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>SINCE 2000</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>SINCE 2000</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>SINCE 2000</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugdosagetext>SINCE 10 YEARS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134031-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-15409881</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugauthorizationnumb>009218</drugauthorizationnumb>
        <drugdosagetext>COUMADINE 5 MG; 1 DF= 0.5/DAY INTERRUPTED ON OCT10</drugdosagetext>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDENSIEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134032-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100924</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-BRISTOL-MYERS SQUIBB COMPANY-15415847</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APROVEL</medicinalproduct>
        <drugauthorizationnumb>020757</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugauthorizationnumb>020357</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugauthorizationnumb>074258</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134033-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15416761</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>ONGLYZA</medicinalproduct>
        <drugauthorizationnumb>022350</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134034-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRACCO-005504</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI-ASTHMATICS</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTIHANCE</medicinalproduct>
        <drugauthorizationnumb>021357</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MASS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTIHANCE</medicinalproduct>
        <drugauthorizationnumb>021357</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NUCLEAR MAGNETIC RESONANCE IMAGING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101108</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134035-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BRISTOL-MYERS SQUIBB COMPANY-15411978</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugindication>TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134036-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-BRISTOL-MYERS SQUIBB COMPANY-15410194</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ ORAL SOLN</medicinalproduct>
        <drugdosagetext>NO OF COURSE:4</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugdosagetext>NO OF COURSE:4</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMTRICITABINE</medicinalproduct>
        <drugdosagetext>NO OF COURSE:4</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORMAL SALINE</medicinalproduct>
        <drugdosagetext>NORMAL SALINE NOSE DROPS</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101120</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134037-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-15412307</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>POLYDIPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WATER INTOXICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugdosagetext>NOOF ISOLATIONS: 3-10 TIMES/YEAR</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOMEPROMAZINE MALEATE</medicinalproduct>
        <drugdosagetext>NOOF ISOLATIONS: 3-10 TIMES/YEAR</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEROSPIRONE</medicinalproduct>
        <drugdosagetext>NOOF ISOLATIONS: 27 TIMES/YEAR</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134038-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-15414428</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABATACEPT</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071219</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOLATE</medicinalproduct>
        <drugdosagetext>TABLET, STARTED PRIOR TO OBTAINING INFORMED CONSENT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER D</medicinalproduct>
        <drugdosagetext>TABLET, STARTED PRIOR TO OBTAINING INFORMED CONSENT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENET</medicinalproduct>
        <drugdosagetext>TABLET, STARTED PRIOR TO OBTAINING INFORMED CONSENT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>TABLET, STARTED PRIOR TO OBTAINING INFORMED CONSENT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIAMIN</medicinalproduct>
        <drugdosagetext>TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101024</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134039-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15416704</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORENCIA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134043-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-JNJFOC-20101108420</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>SELF INJURIOUS BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLUGGISHNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugauthorizationnumb>015923</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINIAS</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134044-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-JNJFOC-20101200030</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SELF INJURIOUS BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLUGGISHNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugauthorizationnumb>015923</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134045-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20101200678</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugauthorizationnumb>015923</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DELIRIUM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101017</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DELIRIUM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DELIRIUM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DELIRIUM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DELIRIUM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134046-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-JNJFOC-20101108184</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>DRUG ADMINISTERED AT INAPPROPRIATE SITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugdosagetext>2 PATCHES OF 12.5UG/HR</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugdosagetext>1 PATCH OF 12.5UG/HR</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134047-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20090303411</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>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SPINAL COLUMN STENOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPINAL COLUMN STENOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134048-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-JNJFOC-20101108195</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>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugdosagetext>HALF A PATCH OF 12.5UG/HR</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134049-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20101105782</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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM REPOLARISATION ABNORMALITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOGLOBIN BLOOD INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugdosagetext>THALIDOMIDE CELGENE*</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARDEGIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAFALGAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134050-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20101104473</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>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134051-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20101200041</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>96</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134052-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20101200061</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>UTERINE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134053-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20101201179</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>92</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUROTEP MT</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134054-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101108173</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
        <drugdosagetext>20-25MG/ ONCE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>20-25MG/ ONCE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>20-25MG/ ONCE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FLUID RETENTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR</medicinalproduct>
        <drugdosagetext>20-25MG/ ONCE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ELECTROLYTE SUBSTITUTION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134055-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101108203</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS CONTACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134056-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-15384746</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugauthorizationnumb>020262</drugauthorizationnumb>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugauthorizationnumb>019880</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134057-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-BRISTOL-MYERS SQUIBB COMPANY-15399603</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OPTIC NEURITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STREPTOMYCIN</medicinalproduct>
        <drugauthorizationnumb>060108</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MENINGITIS TUBERCULOUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugdosagetext>5MG/KG/D DIV THREE DOSES</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TUBERCULOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFAMPICIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TUBERCULOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PYRAZINAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TUBERCULOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134058-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ROXANE LABORATORIES, INC.-2010-RO-01560RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INHIBITORY DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
        <drugauthorizationnumb>090072</drugauthorizationnumb>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETORICOXIB</medicinalproduct>
        <drugindication>PERIARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134059-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-12995BP</companynumb>
    <primarysource>
      <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>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugdosagetext>0.8 MG</drugdosagetext>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100404</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134060-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-BRISTOL-MYERS SQUIBB COMPANY-15191737</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT GLOBAL AMNESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORENCIA</medicinalproduct>
        <drugdosagetext>LAST DOSE ON 15JUN10,06AUG10,09-NOV-2010 NO OF INF:10</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134061-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13212BP</companynumb>
    <primarysource>
      <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>SPIRIVA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134063-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-15404759</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORENCIA</medicinalproduct>
        <drugdosagetext>ADMISTD 3 TIMES. THERAPY DATES:8OCT10,22OCT10</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100924</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134064-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13167BP</companynumb>
    <primarysource>
      <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>003153B</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134065-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-15061112</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>109</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS POSTURAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>STRENGTH=5MG/ML PERMANENT DISCONTINUED ON 29MAR10.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100329</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>MOST RECENT INF:29-MAR-2010;FREQUENCY=80 MG/M2,ON DAY 1 OF CYCLE PERMANENT DISCONTINUED ON 29MAR10</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100329</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>DF=TABS,1000MG/M2 ON DAY 1-15 RECENT INFUSION ON 6APR10 PERMANENT DISCONTINUED ON 6APR10</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100406</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134066-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15400047</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</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECALOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>PULLED OFF 16APR2009 6DF:6AUC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090326</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>PULLED OFF 16APR2009</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090326</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090402</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090312</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090402</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090326</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090326</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090402</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134067-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15130867</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>159</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100519</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>1 DF: 6 AUC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100519</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100519</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>SEASONAL ALLERGY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARINOL</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100409</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100519</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100519</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100519</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOXI</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100519</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134068-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-BRISTOL-MYERS SQUIBB COMPANY-15194145</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>50</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>RECENT INF:30JUN10,INITIAL DOSE=400MG/M2 OVER 120MIN NO OF INF:2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEAD AND NECK CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100630</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>RECENT INF:23JUN10,75MG/M2 IV INF OVER 60 MINTS ON DAY 1,750MG/M2/DAY INF OVER 24HRS. NO OF INF:2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEAD AND NECK CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100623</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>RECENT INF:27JUN10,75MG/M2 IV INF OVER 60 MINTS ON DAY 1.750MG/M2/DAY INF OVER 24HRS. NO OF INF:2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEAD AND NECK CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100627</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134069-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CL-BRISTOL-MYERS SQUIBB COMPANY-15300890</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>MOST RECENT INF:03SEP2010 RESTARTED ON:24SEP10</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100409</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>ON DAY 1 OF CYCLE:MOST RECENT INF:27AUG2010 RESTARTED ON:24SEP10</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100409</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>ON DAY 1-15:MOST RECENT INF:10SEP2010 RESTARTED ON:24SEP10</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100827</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134070-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-15350051</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>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCHIZOPHRENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>08JUN-30AUG10(84DAYS),27MG 31AUG-4OCT10(35D),24MG 5OCT-11OCT10(7D),30MG 12-13OCT10(2D).</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>TABLET:6MG:QD:ORAL:13OCT10 9MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101013</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYSLEE</medicinalproduct>
        <drugdosagetext>12OCT10:5MG/D,13OCT:UNK:10MG/D,23OCT10:UNK:5MG/D TABS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIPERIDEN HYDROCHLORIDE TAB</medicinalproduct>
        <drugdosagetext>TABLET:ONG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101013</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VEGETAMIN-B</medicinalproduct>
        <drugdosagetext>TABLET:ONG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101013</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugdosagetext>TABS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101013</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLARAMINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIRNAMIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101013</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYSTAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101017</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LODOPIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101017</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101005</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134074-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-JNJFOC-20101108891</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugauthorizationnumb>021121</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOMOTOR HYPERACTIVITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134075-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-JNJFOC-20101108681</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>150</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD THYROID STIMULATING HORMONE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICTURITION URGENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugauthorizationnumb>021121</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134076-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20101108636</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HERPES VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugauthorizationnumb>021121</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134077-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20101004040</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AKATHISIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugdosagetext>1 AND HALF 36 MG CAPSULES</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugauthorizationnumb>021121</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134078-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-JNJFOC-20101108375</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGUS NERVE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIASPORIN</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugauthorizationnumb>020083</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CANDIDIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134079-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-JNJFOC-20101108804</companynumb>
    <primarysource>
      <reportercountry>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>EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL BLISTERING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPORANOX</medicinalproduct>
        <drugauthorizationnumb>020083</drugauthorizationnumb>
        <drugdosagetext>STRENGTH OF THE DRUG- 100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TINEA CRURIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134080-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-JNJFOC-20101108803</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPORANOX</medicinalproduct>
        <drugauthorizationnumb>020966</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SYSTEMIC MYCOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134082-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20100803069</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.97</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOWER RESPIRATORY TRACT INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134083-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101100871</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 DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHRONIC SINUSITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134084-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101102439</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134090-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101200151</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>ORM8963701</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134092-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-JNJFOC-20070307185</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134093-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101001333</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>ORMKA83502;ORMKA84101;ORMKA64303</drugbatchnumb>
        <drugdosagetext>TOTAL OF 3 DOSES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-CORTEF</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRAVOL TAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134094-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101200517</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING OF BODY TEMPERATURE CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>0RMKA83502;0RMA64303</drugbatchnumb>
        <drugdosagetext>2ND INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>0RMKA83502;0RMA64303</drugbatchnumb>
        <drugdosagetext>1ST INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESALAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134095-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101006319</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISION SITE ABSCESS</reactionmeddrapt>
      </reaction>
      <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>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugindication>CYSTITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugindication>CYSTITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CODEINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MACROBID</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134096-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20101108419</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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugauthorizationnumb>021346</drugauthorizationnumb>
        <drugdosagetext>INJECTION ON GLUTEAL SITE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134097-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101105579</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugauthorizationnumb>021346</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEMADRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEMADRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EXTRAPYRAMIDAL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134098-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20101108779</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugauthorizationnumb>021346</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134099-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20101004301</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL CONDITION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugauthorizationnumb>021346</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134100-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-JNJFOC-20091000414</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>RISPERDAL</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugauthorizationnumb>021346</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134101-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20101006182</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020588</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ONYCHOMYCOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134102-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20101101864</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090924</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAVOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VASCULAR DEMENTIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAVOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAVOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134103-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20101108714</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>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134104-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20101200279</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>APPROXIMATELY 6 MONTHS PRIOR TO THE REPORT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134105-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20101200423</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EBIXA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVONORM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVISCAN (FLUINDIONE)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COVERSYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134106-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-15407935</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>DELUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>ABILIFY WAS UP-TITRATED TO 30MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLIAN</medicinalproduct>
        <drugdosagetext>SWITCHED FROM 450-600MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134107-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRACCO-005407</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTIHANCE</medicinalproduct>
        <drugbatchnumb>S0P257A</drugbatchnumb>
        <drugauthorizationnumb>021357</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>AORTIC ANEURYSM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTIHANCE</medicinalproduct>
        <drugbatchnumb>S0P257A</drugbatchnumb>
        <drugauthorizationnumb>021357</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANGIOGRAM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>1000 UNIT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>EFFERVESCENT AS NEEDED</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134112-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-TEVA-187754ISR</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugauthorizationnumb>072234</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASTICITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIPAMPERONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090116</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134113-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-JNJFOC-20100403699</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARUNAVIR</medicinalproduct>
        <drugauthorizationnumb>021976</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KIVEXA</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPID MODIFYING AGENTS</medicinalproduct>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134115-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20101102498</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPHENIDATE HCL</medicinalproduct>
        <drugauthorizationnumb>021121</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>019842</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHANOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134116-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20101102493</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPHENIDATE HCL</medicinalproduct>
        <drugauthorizationnumb>021121</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELATONIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134117-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-US-EMD SERONO, INC.-7029266</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>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134118-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-US-EMD SERONO, INC.-7022850</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>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALLOPIAN TUBE ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101008</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134119-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-US-EMD SERONO, INC.-7029494</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <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>REBIF</medicinalproduct>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLORANA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIMODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAMELOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134120-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-US-EMD SERONO, INC.-7025558</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIANE</medicinalproduct>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134121-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010156849</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134122-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010032517</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>BEDRIDDEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugauthorizationnumb>019684</drugauthorizationnumb>
        <drugdosagetext>60 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugauthorizationnumb>019684</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugauthorizationnumb>019684</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>UNK, DAILY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134123-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-PFIZER INC-2010162825</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
        <drugauthorizationnumb>022020</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134124-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2010094497</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULAR PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHLEBITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>5 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED *NO SUBJECT DRUG</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>37.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>37.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUNITINIB MALATE</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>37.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEBIVOLOL</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDEX</medicinalproduct>
        <drugdosagetext>2.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134125-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010148712</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>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugauthorizationnumb>020882</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASTET</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134126-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-PFIZER INC-2010147984</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTRACARDIAC MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXEMESTANE</medicinalproduct>
        <drugauthorizationnumb>020753</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101013</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMILORIDE HCL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134132-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20100101570</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.11</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIAL OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INADEQUATE ANALGESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugdosagetext>100.0 UG/HR PATCHES 2 IN 48 HRS</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0908029</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0908029</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugdosagetext>100.0 UG/HR PATCHES 2 IN 48 HRS</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTIGALL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC STEATOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134133-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-JNJFOC-20100304832</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL DECOMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>NERVE COMPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODUR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANADOL OSTEO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134135-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101201200</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>FENTANYL-100</medicinalproduct>
        <drugbatchnumb>10086702</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugdosagetext>NDC#0781-7112-55</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134136-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101108193</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64.41</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRODUCT ADHESION ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugbatchnumb>1000859</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugdosagetext>NDC #0781-0241-55  5-6 MONTHS AGO</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134137-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20100806111</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>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLANTAR FASCIITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134138-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20100703635</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>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134139-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20100806155</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>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGAMENT RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESPIRATORY TRACT INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134140-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20090705818</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENISCUS LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134141-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20100607063</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134142-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20101109099</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAPILLOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANDEMRIX</medicinalproduct>
        <drugdosagetext>1 DOSE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134143-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20100904027</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONEAL TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIALDA</medicinalproduct>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134144-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101109067</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>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>1ST DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134145-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101109095</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>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>ORMKA88502;ORMKA83002</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>ORMKA88502;ORMKA83002</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMINYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GARLIC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134146-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-JNJFOC-20101200270</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PELVIC FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <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>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134147-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101200278</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>PRECANCEROUS CELLS PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC SPECIFIC ANTIGEN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTOCORT EC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD URIC ACID</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134148-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101006886</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.49</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY SLEEP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULIN TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134149-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-US-EMD SERONO, INC.-7006754</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>HEPATOSPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100907</drugenddate>
        <drugtreatmentduration>109</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134150-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-US-EMD SERONO, INC.-7027984</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION EARLY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GONAL-F</medicinalproduct>
        <drugauthorizationnumb>020378</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101111</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134151-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-US-EMD SERONO, INC.-7011111</companynumb>
    <primarysource>
      <reportercountry>IRELAND</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugindication>SECONDARY PROGRESSIVE MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100604</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100719</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134152-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-US-EMD SERONO, INC.-7021220</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO POSITIONAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134153-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-US-EMD SERONO, INC.-7012040</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
        <drugtreatmentduration>164</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOCETIRIZINE DIHYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101123</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
        <drugindication>MUSCLE SPASMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMILORIDE-HYDROCHLOORTHIAZID</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETIC ACID</medicinalproduct>
        <drugindication>PLATELET AGGREGATION INHIBITION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100609</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE DISKUS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ CODEINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134154-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-US-EMD SERONO, INC.-7028777</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134155-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-US-EMD SERONO, INC.-7029269</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOTIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134156-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-US-EMD SERONO, INC.-7029779</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE LEIOMYOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugbatchnumb>Y16A5407</drugbatchnumb>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090323</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORETIC 100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHARMATON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DORFLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORLOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMOLUT-NOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SARIDON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134157-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-US-EMD SERONO, INC.-220016J10GBR</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>12.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAIZEN</medicinalproduct>
        <drugauthorizationnumb>019764</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAIZEN</medicinalproduct>
        <drugauthorizationnumb>019764</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHOSPHATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM SANDOZ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONE ALPHA CALCIDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOVITE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134158-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-US-EMD SERONO, INC.-7017182</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OVARIAN HYPERSTIMULATION SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETROTIDE</medicinalproduct>
        <drugauthorizationnumb>021197</drugauthorizationnumb>
        <drugindication>POLYCYSTIC OVARIES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100826</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GONAL-F</medicinalproduct>
        <drugauthorizationnumb>020378</drugauthorizationnumb>
        <drugindication>POLYCYSTIC OVARIES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100825</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OVITRELLE</medicinalproduct>
        <drugauthorizationnumb>021149</drugauthorizationnumb>
        <drugindication>POLYCYSTIC OVARIES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100826</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134159-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TN-US-EMD SERONO, INC.-7029468</companynumb>
    <primarysource>
      <reportercountry>TUNISIA</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>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANADOL EXTRA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134160-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-US-EMD SERONO, INC.-7029232</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURAN T4</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELIDEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134161-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-US-EMD SERONO, INC.-7012990</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>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134163-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-US-EMD SERONO, INC.-7022735</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugbatchnumb>Y16A5614</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100922</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134167-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101200021</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FAECALOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>017694</drugauthorizationnumb>
        <drugdosagetext>4 PILLS AT ONE TIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134168-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20101200720</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LONG QT SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
        <drugauthorizationnumb>017694</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MANY OTHER UNSPECIFIED MEDICATIONS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134169-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101108207</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>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAZADYNE</medicinalproduct>
        <drugauthorizationnumb>021169</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GALANTAMINE HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>021169</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APIXABAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APIXABAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANEXA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134170-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101005943</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.08</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER IN SITU</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPUTERISED TOMOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MAMMOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULTRASOUND SCAN ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO-NOVUM 1/50 21</medicinalproduct>
        <drugauthorizationnumb>016709</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134171-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-JNJFOC-20101107640</companynumb>
    <primarysource>
      <reportercountry>POLAND</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>CONDUCT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPOLEPT</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONDUCT DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134172-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20101108264</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugauthorizationnumb>021346</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134173-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-JNJFOC-20101100127</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN SOCIAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANDIOSITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEXUAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugauthorizationnumb>021346</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134174-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20101107484</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PROLACTIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALACTORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASTITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134175-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10091108</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>CELLULITIS STAPHYLOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134176-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-10P-062-0684762-00</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>
      <patientweight>74</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100708</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIGANTOLLETEN 1000</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100818</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090225</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNIHEXAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
        <drugindication>ORAL CANDIDIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134177-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ABBOTT-10P-114-0687409-00</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TERMINAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACENOCOUMAROL</medicinalproduct>
        <drugdosagetext>ACCORDING TO SCHEDULE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMETEROL/FLUTICASON</medicinalproduct>
        <drugdosagetext>50/100 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIOTROPIUM</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>1 DOSE 3-4 TIMES DAILY</drugdosagetext>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134178-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0687390-00</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENISCUS LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIURETIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STENT PLACEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOVASCULAR EVENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM WOMENS VITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134179-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-AMGEN-ARGSP2010005034</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ENTEROCOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101023</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134180-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10100755</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134186-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101102335</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>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugdosagetext>25 MG HOUR OF SLEEP FOR ONE WEEK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>POST-TRAUMATIC STRESS DISORDER</drugindication>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SLEEP-RELATED EATING DISORDER</drugindication>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugdosagetext>25 MG HOUR OF SLEEP FOR ONE WEEK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134187-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TH-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-CS-01031RT</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134188-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-12996BP</companynumb>
    <primarysource>
      <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>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134189-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13567BP</companynumb>
    <primarysource>
      <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>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>O2/CPAP</medicinalproduct>
        <drugdosagetext>1.5 NR</drugdosagetext>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYSTOLIC</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC (GENERIC)</medicinalproduct>
        <drugdosagetext>NOSE PILLOWS</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>NOSE PILLOWS</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>PANIC ATTACK</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134190-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC.-2010-RO-01569RO</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXPRESSIVE LANGUAGE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRIMACING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STARING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TARDIVE DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>072038</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134195-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-SANOFI-AVENTIS-2010SA066965</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL BELOW THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTAQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>022425</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETA BLOCKING AGENTS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134196-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2010SE56395</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>
      <patientweight>158.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOGLOBINURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASPERGER'S DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYBTHROID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134197-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2010SE37788</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>61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMATOSIS INTESTINALIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>021399</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100810</drugenddate>
        <drugtreatmentduration>377</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>021399</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090706</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134198-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10082436</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.813</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <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>20100701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134199-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2010155870</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>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DAYDREAMING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABYRINTHITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
        <drugdosagetext>3 UG, 1X/DAY AT NIGHT</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOPTOL</medicinalproduct>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134200-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2010156017</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>020987</drugauthorizationnumb>
        <drugdosagetext>20 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070626</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134201-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2010151722</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>43</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUTHYROX</medicinalproduct>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>DIURETIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAREVAN ^NYCOMED^</medicinalproduct>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134203-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010092850</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN ODOUR ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE ODOUR ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DETRUSITOL</medicinalproduct>
        <drugauthorizationnumb>021228</drugauthorizationnumb>
        <drugdosagetext>2 MG, DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLIVAS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134204-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-SANOFI-AVENTIS-2010SA067020</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</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>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN LEVEL INCREASED</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>20100929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURBIS</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMILORIDE HCL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134205-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010003512</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ALLOIMMUNISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHTHOUS STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICOBRACHIAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPUTERISED TOMOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS CONTACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENZYME ABNORMALITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KERATOCONJUNCTIVITIS SICCA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SICCA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100521</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WINRHO</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugindication>HERPES ZOSTER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNOGLOBULINS</medicinalproduct>
        <drugindication>MUSCLE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALACICLOVIR</medicinalproduct>
        <drugindication>HERPES ZOSTER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>12.5 MG, QD</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEXOFENADINE HCL SANDOZ</medicinalproduct>
        <drugdosagetext>180 MG, QD</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDES A+B</medicinalproduct>
        <drugdosagetext>8.6 MG, PRN</drugdosagetext>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>1 GTT, BID</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134206-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2010SE56140</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>62</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugauthorizationnumb>019627</drugauthorizationnumb>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMIFENTANIL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VECURONIUM BROMIDE</medicinalproduct>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>MAINTENANCE OF ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134207-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ASTRAZENECA-2010SE50532</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101123</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134208-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2010SE37198</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>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>021399</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090801</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134209-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AMGEN-FRASP2010006098</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROMYOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101020</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134210-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU417383</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1 A?G/KG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>1 A?G/KG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>2 A?G/KG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100622</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134214-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10081811</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>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTATIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100818</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134215-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-SANOFI-AVENTIS-2010SA069766</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTAQ</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022425</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RILMENIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANIDIP</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugdosagetext>100 MG + 80 MG</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACE INHIBITOR NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134216-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-JNJFOC-20100405601</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>48.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <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>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134218-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100812</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-JNJFOC-20100805745</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134219-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20100400091</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>INTESTINAL OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>TO ^THE PRESENT^</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134220-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101108561</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 MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134221-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ASTRAZENECA-2010SE56207</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENTOCORT EC</medicinalproduct>
        <drugauthorizationnumb>021324</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101003</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134222-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2010SE51730</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16532</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101013</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SHAKUYAKU-KANZO-TO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101013</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134223-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2010SE56142</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>CELL DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100923</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLORIC</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUFLOMEDIL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IXPRIM</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOCTRAN</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUROBIOL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100923</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXINE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100923</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100923</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134224-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201009005634</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
        <drugdosagetext>400 D/F, 3/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>25 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugdosagetext>5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugdosagetext>20 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>50000 D/F, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134225-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-AMGEN-CANSP2010003070</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101126</drugenddate>
        <drugtreatmentduration>75</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNIPHYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134226-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ASTRAZENECA-2010SE56254</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>
      <patientweight>72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND COMB</medicinalproduct>
        <drugdosagetext>16/5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOCORDIL</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VASTAREL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NATRILIX</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134227-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2010SE56197</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25320</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPRIVAN</medicinalproduct>
        <drugauthorizationnumb>019627</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101029</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>6 COURSE.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SKENAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101031</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIMBEX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101029</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIPARINE</medicinalproduct>
        <drugdosagetext>5000IU/0.2 ML.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL PANPHARMA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101031</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPIFEN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101031</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFUROXIME PANPHARMA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101029</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXEN</medicinalproduct>
        <drugdosagetext>LONG LASTING.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>LONG LASTING.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOCTRAN</medicinalproduct>
        <drugdosagetext>LONG LASTING.</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134231-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10101501</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>PANCREATIC CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugdosagetext>1</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugdosagetext>10 UNITS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>25 UNITS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUTRA-PHOS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC SULFATE</medicinalproduct>
        <drugdosagetext>220</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
        <drugdosagetext>100  (1)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134233-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20080802681</companynumb>
    <primarysource>
      <reportercountry>INDIA</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>CHOROIDAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL DETACHMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE PROPHYLAXIS</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134234-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-JNJFOC-20101001994</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETIT MAL EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF INJURIOUS BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHLOROGLUCINOL</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134235-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20101200360</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTOSE INTOLERANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134236-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-JNJFOC-20101108296</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTAZOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134237-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TH-NOVOPROD-317817</companynumb>
    <primarysource>
      <reportercountry>THAILAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>16</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugdosagetext>400 IU, TID</drugdosagetext>
        <drugindication>FACTOR VII DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugdosagetext>400 IU, QID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugdosagetext>300 IU, QID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100619</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugdosagetext>200 IU, QID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100620</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugdosagetext>200 IU, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100621</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRESH FROZEN PLASMA</medicinalproduct>
        <drugdosagetext>10 ML/KG.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100617</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugdosagetext>250 MG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100617</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>3.5 MG, TID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100621</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFAZOLIN</medicinalproduct>
        <drugdosagetext>570 MG, TID</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100618</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100616</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100621</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100628</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100615</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100623</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100615</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100620</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100621</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORAL HYDRATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100615</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100616</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100617</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134238-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-312268</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>125.17</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021536</drugauthorizationnumb>
        <drugdosagetext>SLIDING SCALE PROTOCOL</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>SLIDING SCALE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>500 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugdosagetext>12.5 MG, BID WITH FOOD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugdosagetext>10 MG, EVERY 8 HOURS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>300 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>100 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>40 MG, QD BEFORE A MEAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugdosagetext>50 MG, QD AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugdosagetext>100 MG, QD AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugdosagetext>5 MG-500MG  Q4-6 HOURS AS NEEDED FOR PAIN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134239-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-318997</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>47.619</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETIC KETOACIDOSIS</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 1 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>1.2 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>20 IU, TID, BEFORE MEALS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>20 IU, HS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134240-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-NOVOPROD-319048</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>1.58</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID FLEXPEN</medicinalproduct>
        <drugdosagetext>28 U, QD</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100916</drugenddate>
        <drugtreatmentduration>182</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULATARD HM PENFILL</medicinalproduct>
        <drugauthorizationnumb>019959</drugauthorizationnumb>
        <drugdosagetext>16 U, QD</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>GESTATIONAL DIABETES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100916</drugenddate>
        <drugtreatmentduration>182</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134241-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-318936</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>124.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</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>20101109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101112</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>1.2 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OVERWEIGHT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugdosagetext>160/12.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE HCL</medicinalproduct>
        <drugdosagetext>0.2 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134242-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>LB-NOVOPROD-319046</companynumb>
    <primarysource>
      <reportercountry>LEBANON</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugindication>HAEMORRHAGE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134243-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-318989</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>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLIN R</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019938</drugauthorizationnumb>
        <drugdosagetext>2 DOSES</drugdosagetext>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19880101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134244-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-NOVOPROD-318958</companynumb>
    <primarysource>
      <reportercountry>FINLAND</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>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>1.8 MG, QD</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100530</drugenddate>
        <drugtreatmentduration>37</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTIVELLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FURESIS</medicinalproduct>
        <drugdosagetext>20 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISMOX</medicinalproduct>
        <drugdosagetext>1X2</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMCONCOR CHF</medicinalproduct>
        <drugdosagetext>1X1</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASA-RATIOPHARM</medicinalproduct>
        <drugdosagetext>1X1</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
        <drugdosagetext>WHEN NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134245-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NOVOPROD-318687</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>
      <patientweight>63</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACANTHOSIS NIGRICANS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENFILL R CHU</medicinalproduct>
        <drugbatchnumb>NA</drugbatchnumb>
        <drugdosagetext>36 U, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENFILL N CHU</medicinalproduct>
        <drugbatchnumb>NA</drugbatchnumb>
        <drugauthorizationnumb>019959</drugauthorizationnumb>
        <drugdosagetext>12 U, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134248-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-SANOFI-AVENTIS-2010SA071153</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN FISSURES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTAQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>022425</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUTHYROX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134249-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006566</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>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134250-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101128</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006630</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100629</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134254-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101108607</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
        <drugindication>INFLAMMATORY BOWEL DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <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>2</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134255-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-PFIZER INC-2010158500</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>POLYMYALGIA RHEUMATICA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134256-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2010157749</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>BLOOD PROLACTIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>300 MG, 3X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134257-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-PFIZER INC-2010158154</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>POLYMYALGIA RHEUMATICA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134258-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2010160534</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>MICTURITION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROXYZINE HCL</medicinalproduct>
        <drugauthorizationnumb>011459</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101120</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134260-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-20785-10081065</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>PANCREATIC CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>020785</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091230</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100418</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080225</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080225</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134261-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006855</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1021465</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134262-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BAXTER-2010BH028834</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD LIQUID</medicinalproduct>
        <drugbatchnumb>LE12KA46AG</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134266-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-MPIJNJ-2005-02388</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES SIMPLEX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL SENSORY NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1.30 MG/M2, 2/WEEK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050825</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>9.00 MG/M2, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050812</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>40.00 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050903</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134267-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-MEDIMMUNE-MEDI-0011550</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>5.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHIOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED BRONCHIAL SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>ACCORDING TO WEIGHT</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100507</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugindication>BRONCHOPULMONARY DYSPLASIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134268-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101120</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-ELI_LILLY_AND_COMPANY-CO201011006978</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>021368</drugauthorizationnumb>
        <drugdosagetext>1 D/F, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134269-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ELI_LILLY_AND_COMPANY-IT201011005562</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>500 MG/CYCLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>50MG/CYCLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVISACOR</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MODURETIC 5-50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugdosagetext>400 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODIOL</medicinalproduct>
        <drugdosagetext>900 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCRIPTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134270-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-RA-00490RA</companynumb>
    <primarysource>
      <qualification>1</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>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DABIGATRAN ETEXILATE</medicinalproduct>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>220 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOLEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POSTOPERATIVE ANALGESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134271-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13311BP</companynumb>
    <primarysource>
      <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>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134272-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13003BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021698</drugauthorizationnumb>
        <drugdosagetext>150 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPTO BISMOL</medicinalproduct>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134275-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-20785-08010438</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 HUMAN CHORIONIC GONADOTROPIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>020785</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugdosagetext>150-200MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134276-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-ASTRAZENECA-2010SE11002</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DYSAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE I HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100207</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRALGIN</medicinalproduct>
        <drugdosagetext>AS REQUIREDA</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRALGIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100207</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BILOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100207</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELTROXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134277-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2010SE55130</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>
      <patientweight>55</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
        <drugauthorizationnumb>020498</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100819</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOLAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100819</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANDAXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DELIRIUM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100819</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HANP</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100817</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134278-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-ASTRAZENECA-2010SE56213</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
        <drugdosagetext>CYCLIC</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080701</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>CYCLIC</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080701</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugdosagetext>25 MG CYCLIC</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090506</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>20 MG CYCLIC</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091112</drugenddate>
        <drugtreatmentduration>213</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>1.3 MG/M2 CYCLIC</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091112</drugenddate>
        <drugtreatmentduration>171</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRINE BAYER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DISTRANEURIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAFALGAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYNORM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMPORTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DERMOVATE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134282-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CEPHALON-2010006183</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>CHOROIDAL NEOVASCULARISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANTLE CELL LYMPHOMA RECURRENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TREANDA</medicinalproduct>
        <drugauthorizationnumb>022249</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134283-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-CELGENEUS-114-50794-10100577</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYSIPELAS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDAZA</medicinalproduct>
        <drugauthorizationnumb>050794</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CHRONIC MYELOMONOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>TAMSULOSIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134284-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CZ-AMGEN S.R.O.-KDC428534</companynumb>
    <primarysource>
      <reportercountry>CZECH REPUBLIC</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>APHTHOUS STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANITUMUMAB</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100722</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100722</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100722</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACEBUTOLOL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100804</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>8 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100722</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugdosagetext>8 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100722</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPNOGEN</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100817</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134285-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010001508</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>DIFFUSE LARGE B-CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IDIOPATHIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCCULT BLOOD POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>1 A?G/KG, UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081114</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNOGLOBULINS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081013</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134286-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-ASTRAZENECA-2010SE03110</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>ABORTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134287-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-ASTRAZENECA-2010SE56220</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FASLODEX</medicinalproduct>
        <drugauthorizationnumb>021344</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101008</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REDIMMUNE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MST</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KONAKION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMPORTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134288-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2010SE54171</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>HEPATITIS CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugauthorizationnumb>018240</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNIKET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100713</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADIRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100714</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100712</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100730</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DISTRANEURINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AGITATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100707</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100709</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134289-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101121</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-SANOFI-AVENTIS-2010SA071177</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</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>ACUTE CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</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>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORMITEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUSID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134290-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010004521</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>NPLATE</medicinalproduct>
        <drugdosagetext>10.6 A?G/KG, UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WINRHO</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100527</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134291-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010001593</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</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>PROCRIT</medicinalproduct>
        <drugdosagetext>40000 IU, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101005</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugindication>LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134292-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010005439</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA PRIMARY ATYPICAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1022274</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134293-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-KDC437223</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANITUMUMAB</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>6 MG/KG, Q2WK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100720</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>100 MG, Q2WK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100720</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>450 MG, Q2WK</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100720</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>2500 MG, Q2WK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100720</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM LEVOFOLINATE</medicinalproduct>
        <drugdosagetext>240 MG, Q2WK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100720</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTROM</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTROM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULCERLMIN</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULCERLMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMAC D</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMAC D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTECADIN</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTECADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOFERMIN R</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOXI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134294-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010004428</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>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134295-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010004483</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CEREBELLAR ARTERY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>UNK MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE SULFATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE SULFATE</medicinalproduct>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134296-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-AMGEN-QUU434217</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENIC INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugbatchnumb>1015967</drugbatchnumb>
        <drugdosagetext>300 A?G, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>AGRANULOCYTOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100815</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOXACILLIN SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100825</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100816</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134297-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010003295</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>1 A?G/KG, UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100520</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100429</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100505</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMETANIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134298-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ASTRAZENECA-2010SE55939</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>OEDEMA MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
        <drugauthorizationnumb>019834</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
        <drugauthorizationnumb>019834</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
        <drugauthorizationnumb>019834</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100922</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134299-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CEPHALON-2010006237</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTIQ</medicinalproduct>
        <drugbatchnumb>C60390</drugbatchnumb>
        <drugauthorizationnumb>020747</drugauthorizationnumb>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>NECK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugindication>NECK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAVELLA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN CR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134304-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU442073</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>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>80 A?G, UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100811</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROID NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134305-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010002690</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FUSION SURGERY</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>
      <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>20100501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNK UNK, QWK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>80 MG, QOD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>UNK UNK, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D             /00944201/</medicinalproduct>
        <drugdosagetext>50 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOCINONIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOCARBAMOL</medicinalproduct>
        <drugdosagetext>750 MG, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugdosagetext>UNK UNK, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>5 MG, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>80 MG, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>40 MEQ, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMCINOLONE</medicinalproduct>
        <drugdosagetext>.025 %, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>0.25 MG, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134306-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010001593</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>PROCRIT</medicinalproduct>
        <drugdosagetext>40000 IU, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101005</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugindication>LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134307-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-10P-028-0680075-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>101</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>FIRST REGISTRY DOSE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERSYL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETROL</medicinalproduct>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugdosagetext>80 MG/ML</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRO-DUR</medicinalproduct>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHO-NITRO PUMPSPRAY</medicinalproduct>
        <drugdosagetext>1 SPRAY</drugdosagetext>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>ROUTINE HEALTH MAINTENANCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134308-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-318928</companynumb>
    <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 SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCAL SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021536</drugauthorizationnumb>
        <drugdosagetext>25 IU, HS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134309-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-318935</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>104</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugbatchnumb>YS61418</drugbatchnumb>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>0.6 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101112</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugbatchnumb>YS61418</drugbatchnumb>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>1.2 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101114</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134310-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-NOVOPROD-317930</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIXTARD HUMAN 70/30</medicinalproduct>
        <drugauthorizationnumb>019991</drugauthorizationnumb>
        <drugindication>OFF LABEL USE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>48 TAB, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134311-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>LB-NOVOPROD-319063</companynumb>
    <primarysource>
      <reportercountry>LEBANON</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugindication>HAEMORRHAGE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134312-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-NOVOPROD-317918</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>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VICTIM OF HOMICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLIN 70/30</medicinalproduct>
        <drugauthorizationnumb>019991</drugauthorizationnumb>
        <drugindication>OFF LABEL USE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134313-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-NOVOPROD-317913</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>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VICTIM OF HOMICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLIN 70/30</medicinalproduct>
        <drugauthorizationnumb>019991</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OFF LABEL USE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134314-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-NOVOPROD-317182</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULATARDA? PENFILLA? HM(GE) 3 ML</medicinalproduct>
        <drugbatchnumb>YK70254</drugbatchnumb>
        <drugauthorizationnumb>019959</drugauthorizationnumb>
        <drugdosagetext>90 IU, QD (70+20)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010316</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULATARDA? PENFILLA? HM(GE) 3 ML</medicinalproduct>
        <drugauthorizationnumb>019959</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101017</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>500 MG, QID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXOCOBALAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
        <drugdosagetext>10 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUTRANS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETORICOXIB</medicinalproduct>
        <drugdosagetext>60 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREGABALIN</medicinalproduct>
        <drugdosagetext>150 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRIDAMOLE</medicinalproduct>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULOXETINE</medicinalproduct>
        <drugdosagetext>60 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-CODAMOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugdosagetext>15 ML, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADCAL-D3</medicinalproduct>
        <drugdosagetext>1 TAB, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134315-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-312538</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>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100729</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSAID''S</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134316-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010122487</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
        <drugdosagetext>400 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134317-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2010148738</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTATIC RENAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY, 4 WEEKS ON/2 WEEKS OFF</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY, 4 WEEKS ON/2 WEEKS OFF</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KAYEXALATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPECIAFOLDINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101104</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTISKENAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOLIPRANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAFALGAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134318-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2010162535</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS PARALYTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugauthorizationnumb>011459</drugauthorizationnumb>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101108</drugenddate>
        <drugtreatmentduration>45</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugdosagetext>1.5 MG/M2, AT DAY-8, DAY-15, DAY-22 AND DAY-29</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101023</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUBAIN</medicinalproduct>
        <drugdosagetext>28 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101108</drugenddate>
        <drugtreatmentduration>226</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAROXYL</medicinalproduct>
        <drugdosagetext>50 DROPS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101014</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134319-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-PFIZER INC-2010162565</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALMONELLOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
        <drugauthorizationnumb>020987</drugauthorizationnumb>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>20 MG; 4 DOSES IN 1 WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINTROM</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100818</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SORTIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134320-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2009AP03131</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25766</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS INFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TORSADE DE POINTES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPRIVAN</medicinalproduct>
        <drugauthorizationnumb>019627</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090429</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPRIVAN</medicinalproduct>
        <drugauthorizationnumb>019627</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090430</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPRIVAN</medicinalproduct>
        <drugauthorizationnumb>019627</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPRIVAN</medicinalproduct>
        <drugauthorizationnumb>019627</drugauthorizationnumb>
        <drugdosagetext>0.98 MG/KG/HOUR</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RASENAZOLIN</medicinalproduct>
        <drugdosagetext>NUMBER OF DIVIDED DOSES UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ENDOCARDITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090417</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RASENAZOLIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
        <drugdosagetext>NUMBER OF DIVIDED DOSES UNKNOWN</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>ENDOCARDITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN HCL</medicinalproduct>
        <drugdosagetext>NUMBER OF DIVIDED DOSES UNKNOWN</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>ENDOCARDITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAL INJECTION</medicinalproduct>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELASPOL</medicinalproduct>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMINATE</medicinalproduct>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUMINAR</medicinalproduct>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INTRALIPOS10%</medicinalproduct>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugdosagetext>STARTED BEFORE 25-MAR-2009</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LECICARBON</medicinalproduct>
        <drugdosagetext>AS REQUIRED STARTED BEFORE MAR-2009</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
        <drugdosagetext>AS REQUIRED STARTED BEFORE MAR-2009</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAC-B</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090429</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAL TABLETS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090429</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA DUE TO RENAL DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090423</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASCON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090429</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134321-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA072315</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>115</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNDERDOSE</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>20091101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTAQ</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022425</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134322-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20081212</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-CELGENEUS-056-21880-10110504</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOTOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080315</drugenddate>
        <drugtreatmentduration>90</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROPOIETIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134323-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NOVOPROD-317899</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>94</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANTI-INSULIN ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugbatchnumb>N/A</drugbatchnumb>
        <drugauthorizationnumb>021536</drugauthorizationnumb>
        <drugdosagetext>10 TO 14 U</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090727</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID CHU FLEXPEN</medicinalproduct>
        <drugbatchnumb>N/A</drugbatchnumb>
        <drugdosagetext>51 U, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLIN R</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INNOLET N CHU</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>120 U, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090727</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APIDRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugdosagetext>7.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NU-LOTAN</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEIBULE</medicinalproduct>
        <drugdosagetext>150 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETA                               /00065701/</medicinalproduct>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLORIC</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134327-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ASTRAZENECA-2010SE56039</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISOPROLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FURORESE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL IMPAIRMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080821</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080821</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREGABALIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYNEUROPATHY ALCOHOLIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYNEUROPATHY ALCOHOLIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIFROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYNEUROPATHY ALCOHOLIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FALITHROM ^HEXAL^</medicinalproduct>
        <drugdosagetext>3 MG; ZIEL-INR 2-3</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY EMBOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEROTEC</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134328-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ASTRAZENECA-2010SE54680</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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 INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugauthorizationnumb>018240</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>DISTRANEURINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AGITATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100707</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ADIRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100730</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CARDYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100712</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100714</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>UNIKET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100713</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100709</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134329-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101200178</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLON CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCESSIVE GRANULATION TISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYODERMA GANGRENOSUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>47TH DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>50 MG 13 HOURS, 7 HOURS, AND 1 HOUR BEFORE INFUSION</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134330-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20090901468</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATOSPLENIC T-CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>ON INFLIXIMAB FOR 6 YEARS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134331-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006627</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>AMNIOTIC FLUID VOLUME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTPARTUM VAGINAL LACERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134332-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-CELGENEUS-144-21880-10021835</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091013</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091013</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROPOIETIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134333-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201009002876</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR GRAFT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A709633D</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A723778C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEO-DUR</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISORBIDE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPRAL</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPID</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>GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SINUS DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL WITH CODEIN #4</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134334-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ELI_LILLY_AND_COMPANY-CA201010003817</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 ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS NECROTISING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>15 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIVAL</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>25 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>25 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>75 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>100 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134335-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-CELGENEUS-083-C5013-10112925</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CC-5013</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101026</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURESIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOBIVON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOBETIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101020</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134336-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-CELGENEUS-009-21880-10112957</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>B-CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIC SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101122</drugenddate>
        <drugtreatmentduration>111</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROMIPLOSTIM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAZOLAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134340-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2010158871</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>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAHOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>40MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134341-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2010162742</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugauthorizationnumb>011459</drugauthorizationnumb>
        <drugdosagetext>50 MG, SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101106</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONTRAMAL</medicinalproduct>
        <drugdosagetext>100 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101106</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugdosagetext>40 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAHOR</medicinalproduct>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZANTAC</medicinalproduct>
        <drugdosagetext>300 MG, 1X/DAY</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
        <drugdosagetext>0.5 IU, 2X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134342-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-CELGENEUS-056-21880-10113019</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>47</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100128</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134343-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SK-CELGENEUS-260-21880-10111078</companynumb>
    <primarysource>
      <reportercountry>SLOVAKIA (Slovak Republic)</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>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134347-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20101107325</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FINIBAX</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>LIVER ABSCESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FINIBAX</medicinalproduct>
        <drugauthorizationnumb>022106</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIMATIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZULFIDINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134348-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20100903164</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADRENAL INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ADRENOCORTICAL INSUFFICIENCY ACUTE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134349-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-ASTRAZENECA-2010SE56212</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DORMICUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100622</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134350-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13574BP</companynumb>
    <primarysource>
      <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>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134351-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13517BP</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>BLOOD TEST ABNORMAL</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>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugindication>SPINAL COLUMN STENOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>SPINAL COLUMN STENOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugindication>SPINAL COLUMN STENOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugindication>CANDIDIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
        <drugindication>CANDIDIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134352-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SK-CELGENEUS-260-21880-10110915</companynumb>
    <primarysource>
      <reportercountry>SLOVAKIA (Slovak Republic)</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>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100301</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI-DIABETICS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134353-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10113241</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>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134359-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20101108880</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHOCLONE OKT3</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134360-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20101201188</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHOCLONE OKT3</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134361-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-JNJFOC-20100908812</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134362-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20101106997</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>APPENDICITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDICITIS PERFORATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <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>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134363-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101200172</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 INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRAVOL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134364-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20101200262</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>3 INFUSIONS; ON THERAPY FOR 6 MONTHS.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134365-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-CELGENEUS-056-C5013-10022143</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CC-5013</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100222</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CC-5013</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091230</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091230</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100225</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100225</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100225</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100225</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHIMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100225</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100225</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFUZOSIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100225</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BONE PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100225</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134366-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-9500934</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUPILS UNEQUAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134367-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2010152864</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TREVILOR RETARD</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100903</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>TREVILOR RETARD</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>150 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100907</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100902</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100907</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100908</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134368-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160308</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>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugauthorizationnumb>018972</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134369-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-PFIZER INC-2010139000</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</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>AORTIC DISSECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUNITINIB MALATE</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101019</drugenddate>
        <drugtreatmentduration>419</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABETALOL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100930</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICARDIPINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134370-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-PFIZER INC-2010146783</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugauthorizationnumb>017794</drugauthorizationnumb>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAMIPEXOLE</medicinalproduct>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUETIAPINE</medicinalproduct>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAZODONE</medicinalproduct>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DULOXETINE</medicinalproduct>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134371-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160086</companynumb>
    <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>NICOTROL</medicinalproduct>
        <drugauthorizationnumb>020714</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134377-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CEPHALON-2010006125</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>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVIGIL</medicinalproduct>
        <drugauthorizationnumb>021875</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SOMNOLENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101121</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVIGIL</medicinalproduct>
        <drugauthorizationnumb>021875</drugauthorizationnumb>
        <drugindication>SLEEP APNOEA SYNDROME</drugindication>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134378-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-ELI_LILLY_AND_COMPANY-CO201011006571</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</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>HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>021411</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134379-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ELI_LILLY_AND_COMPANY-CA201011005578</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 PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCORIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>12.5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>15 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIVAL</medicinalproduct>
        <drugdosagetext>1250 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugdosagetext>5 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>0.25 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>0.05 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRA-ZIDE</medicinalproduct>
        <drugdosagetext>25 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MACROBID</medicinalproduct>
        <drugdosagetext>100 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL</medicinalproduct>
        <drugdosagetext>100 UG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134380-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-ELI_LILLY_AND_COMPANY-CH201011006768</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>30 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugdosagetext>45 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETROL</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101115</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134381-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BG-ELI_LILLY_AND_COMPANY-BG201010003370</companynumb>
    <primarysource>
      <reportercountry>BULGARIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APTYALISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED ACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCOHERENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPADHERA</medicinalproduct>
        <drugbatchnumb>A694956</drugbatchnumb>
        <drugauthorizationnumb>022173</drugauthorizationnumb>
        <drugdosagetext>405 MG, MONTHLY (1/M)</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>5 MG/KG, BEFORE 12H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101007</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134386-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA79939</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091120</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134387-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR27153</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC PACEMAKER INSERTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>2 TABLETS A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134388-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR26209</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 INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN AMLO FIX</medicinalproduct>
        <drugauthorizationnumb>021990</drugauthorizationnumb>
        <drugdosagetext>160/5 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134389-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA80349</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DENTAL OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134390-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010ZA73680</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXFORGE</medicinalproduct>
        <drugauthorizationnumb>021990</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101031</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134391-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2010GB00678</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>250 MG, QD</drugdosagetext>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULPIRIDE</medicinalproduct>
        <drugdosagetext>400 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON SUPPLEMENTS</medicinalproduct>
        <drugdosagetext>400 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134392-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2010GB05219</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>APPENDICECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDICITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080926</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134393-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR26219</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>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN TRIPLE</medicinalproduct>
        <drugauthorizationnumb>022314</drugauthorizationnumb>
        <drugdosagetext>160/12.5/5 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134394-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2010GB05199</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>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>450 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090521</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134395-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR25726</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR GRAFT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN AMLO FIX</medicinalproduct>
        <drugauthorizationnumb>021990</drugauthorizationnumb>
        <drugdosagetext>COATED TABLET (160/5 MG)</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134396-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010MX80331</companynumb>
    <primarysource>
      <reportercountry>MEXICO</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>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG/100 ML, YEARLY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPEUTICS NOS</medicinalproduct>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134397-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2008US02660</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>ADRENAL MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL DISEASE CARRIER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DEVELOPMENT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC PACEMAKER INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CENTRAL VENOUS CATHETERISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLOSTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCUTANEOUS FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL FUNCTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL RESECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOLOGICAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SIGMOIDECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT                                 /UNK/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NARCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPOSYN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCELEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INAPSINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugdosagetext>1 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SANDOSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FASLODEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPEUTICS NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROXANOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND HYDROCODONE BITARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ CODEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOTRIMAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIAC</medicinalproduct>
        <drugdosagetext>60 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>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
        <drugdosagetext>150 MG, Q6H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
        <drugdosagetext>150 MG, QID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugdosagetext>1 DF, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>400 MG, Q6H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
        <drugdosagetext>250 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLENDIL</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134398-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR26270</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIAL CATHETERISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIAL OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORNEAL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR GRAFT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN AMLO FIX</medicinalproduct>
        <drugauthorizationnumb>021990</drugauthorizationnumb>
        <drugdosagetext>ONE TABLET DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>ONE TABLET 3 TIMES DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENSINA</medicinalproduct>
        <drugdosagetext>ONE TABLET AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134399-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR80679</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BEDRIDDEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugbatchnumb>UNK.</drugbatchnumb>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5MG/100ML</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134400-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010AU76781</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIASVEA</medicinalproduct>
        <drugdosagetext>150 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROTONIN</medicinalproduct>
        <drugdosagetext>250/ 125</drugdosagetext>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134401-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US77775</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>HAEMORRHAGE URINARY TRACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS FLOATERS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugbatchnumb>F0115</drugbatchnumb>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1000 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>150 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>25 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL WITH ULTRAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROVEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIDAZA</medicinalproduct>
        <drugdosagetext>UNK, EVERY6 WEEK FOR 7 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134402-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010AU45523</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRISMUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134403-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010NL54396</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSTRUCTED LABOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>S-OIV FOCETRIA 7.5AG 100% MF59 V-V111-A+INJ</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>S-OIV FOCETRIA 7.5AG 100% MF59 V-V111-A+INJ</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNTOCINON</medicinalproduct>
        <drugdosagetext>5E</drugdosagetext>
        <drugindication>INDUCED LABOUR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNTOCINON</medicinalproduct>
        <drugdosagetext>10 E</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPIATE</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLAMOXYL</medicinalproduct>
        <drugdosagetext>500 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>500 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TURBOHALER</medicinalproduct>
        <drugdosagetext>400 MCG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENICILLIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134404-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR27328</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugdosagetext>160/12.5 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134406-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR27290</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN TRIPLE</medicinalproduct>
        <drugauthorizationnumb>022314</drugauthorizationnumb>
        <drugdosagetext>1 TABLET (160/10/12.5 MG) DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134407-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2010GB05106</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>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>200MG MANE AND 225MG NOCTE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100819</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>200MG MANE AND 250MG NOCTE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENSURE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugdosagetext>15 ML</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FYBOGEL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUDOCREM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ANAL ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALAMINE LOTION</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>ALTERNATE DAYS</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>RECTAL ULCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134408-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR27737</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>107</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INADEQUATELY CONTROLLED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE AND VALSARTAN</medicinalproduct>
        <drugauthorizationnumb>021990</drugauthorizationnumb>
        <drugdosagetext>1 TABLET OF EACH ACTIVE IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NATRILIX</medicinalproduct>
        <drugdosagetext>1 TABLET DAILY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134409-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101128</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010ZM81607</companynumb>
    <primarysource>
      <reportercountry>ZAMBIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASPHYXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COARTEM</medicinalproduct>
        <drugauthorizationnumb>022268</drugauthorizationnumb>
        <drugindication>MALARIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134410-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010TR79324</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ACROMEGALY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134411-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA81027</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134412-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US56241</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82.993</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTAVIA</medicinalproduct>
        <drugdosagetext>0.187 MG, QOD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100716</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTAVIA</medicinalproduct>
        <drugdosagetext>0.25 MG, QOD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100716</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134414-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010FR61524</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIANOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FRACTAL</medicinalproduct>
        <drugauthorizationnumb>020261</drugauthorizationnumb>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERMIXON</medicinalproduct>
        <drugdosagetext>2 CAPSULES IN MORNING</drugdosagetext>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091009</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134415-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP43353</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBARACHNOID HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ICL670A ICL+DISTAB</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1250 MG,DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON OVERLOAD</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090519</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ICL670A ICL+DISTAB</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>625 MG,DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090731</drugenddate>
        <drugtreatmentduration>73</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>200 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>APLASTIC ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>150 MG,DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090731</drugenddate>
        <drugtreatmentduration>84</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>APLASTIC ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090731</drugenddate>
        <drugtreatmentduration>157</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugdosagetext>0.25 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090730</drugenddate>
        <drugtreatmentduration>210</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAKTAR</medicinalproduct>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090731</drugenddate>
        <drugtreatmentduration>149</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD TRANSFUSION</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134416-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP70005</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 PRESSURE DIASTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARASMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>40 MG, ONCE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100226</drugenddate>
        <drugtreatmentduration>504</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KNORAMIN L</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>80 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITOROL</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugdosagetext>1.5 G, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134417-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010NZ80001</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</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>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000510</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134418-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA81096</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>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080122</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134419-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010MY42618</companynumb>
    <primarysource>
      <reportercountry>MALAYSIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AUTONOMIC NERVOUS SYSTEM IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATATONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134420-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US63874</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORADIL</medicinalproduct>
        <drugauthorizationnumb>020831</drugauthorizationnumb>
        <drugdosagetext>1 CAPSULE TWICE A DAILY</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134421-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US81224</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134422-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2010GB02160</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>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE FRACTURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>500MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIPIPRAZOLE</medicinalproduct>
        <drugdosagetext>5MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugdosagetext>100MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AFFECTIVE DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134423-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010PL22378</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO CENTRAL NERVOUS SYSTEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORCHIDECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TESTICULAR GERM CELL TUMOUR MIXED STAGE I</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMATINIB</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG/DAY</drugdosagetext>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMATINIB</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>300 MG PER DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134424-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA81134</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>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091026</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134425-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010FI81209</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC LYMPHOCYTIC LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
        <drugauthorizationnumb>020261</drugauthorizationnumb>
        <drugdosagetext>80 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101026</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134426-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010TW13106</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</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>BLINDED ALISKIREN ALI+TAB+CF</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED ENALAPRIL COMP-ENA+</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED NO TREATMENT RECEIVED NOMED</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALISKIREN</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100301</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMPARATOR ENALAPRIL</medicinalproduct>
        <drugdosagetext>10 MG,</drugdosagetext>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100301</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISORBIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134427-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2010GB03785</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS EXCISION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</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>20040608</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134428-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP81118</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>48</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081113</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>160 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALBLOCK</medicinalproduct>
        <drugdosagetext>16 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>50 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134429-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2010GB05257</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>COELIAC DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>100 MG MANE + 200 MG NOCTE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981125</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134430-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2010GB04820</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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</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>20020621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101006</drugenddate>
        <drugtreatmentduration>3030</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134431-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP75176</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOALDOSTERONISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>020539</drugauthorizationnumb>
        <drugdosagetext>125 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101030</drugenddate>
        <drugtreatmentduration>60</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134432-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR25282</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORASEQ</medicinalproduct>
        <drugauthorizationnumb>020831</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134433-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010SI81825</companynumb>
    <primarysource>
      <reportercountry>SLOVENIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC SPECIFIC ANTIGEN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONATE T29581+</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG EVERY 28 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081214</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134434-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010KR81255</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091231</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134435-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2009CA31024</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPYEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HYPOMOTILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENT DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1250 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELOFIBROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090603</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1125 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYUREA</medicinalproduct>
        <drugdosagetext>500 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STOOL SOFTENER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WATER PILLS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134436-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2009JP24814</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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESUSCITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMULECT</medicinalproduct>
        <drugdosagetext>20 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050413</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMULECT</medicinalproduct>
        <drugdosagetext>20 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050417</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>250 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050411</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext>2000 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050411</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050830</drugenddate>
        <drugtreatmentduration>123</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050417</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TANADOPA</medicinalproduct>
        <drugdosagetext>2250 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETILEFRINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>6 DF</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYRADIN S</medicinalproduct>
        <drugdosagetext>75 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOSIN</medicinalproduct>
        <drugdosagetext>0.125 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050716</drugenddate>
        <drugtreatmentduration>103</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090429</drugenddate>
        <drugtreatmentduration>1478</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134437-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010MX45264</companynumb>
    <primarysource>
      <reportercountry>MEXICO</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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG/100 ML</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090315</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134438-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010FR81551</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG/100 ML</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134439-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2010GB05663</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>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060306</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134440-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR81394</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>TEGRETOL-XR</medicinalproduct>
        <drugbatchnumb>UNK.</drugbatchnumb>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>UNK,UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134441-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP35350</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>CGS 20267 T30748+TAB</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugdosagetext>2.5 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090902</drugenddate>
        <drugtreatmentduration>1157</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>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060704</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAUZELIN</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060704</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134442-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010AR17700</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVERSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED ALISKIREN ALI+TAB+CF</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>CODE NOT BROKEN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
        <drugtreatmentduration>99</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED ENALAPRIL COMP-ENA+</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>CODE NOT BROKEN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
        <drugtreatmentduration>99</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED NO TREATMENT RECEIVED NOMED</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>CODE NOT BROKEN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
        <drugtreatmentduration>99</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALISKIREN</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMPARATOR ENALAPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134443-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA80732</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100224</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134444-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP78216</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>BRAIN CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>160MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTIST</medicinalproduct>
        <drugdosagetext>10MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugdosagetext>200MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGLAX</medicinalproduct>
        <drugdosagetext>660MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>2.5MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPADEL</medicinalproduct>
        <drugdosagetext>1200MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134445-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010DE17069</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FTY 720 FTY+</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100909</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134446-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR81649</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>ANAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CATAFLAM</medicinalproduct>
        <drugbatchnumb>UNK.</drugbatchnumb>
        <drugauthorizationnumb>020142</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SWELLING</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134447-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP80590</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>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>NEPHROTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLORIC</medicinalproduct>
        <drugindication>NEPHROTIC SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEVALOTIN</medicinalproduct>
        <drugindication>NEPHROTIC SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134453-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-MPIJNJ-2010-06027</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO MENINGES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021602</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134454-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-NOVEN-10IL001416</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugauthorizationnumb>021299</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZILECT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STALEVO 100</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134455-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH022424</companynumb>
    <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 INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134460-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA042589</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>44</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYDIPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLOSTAR</medicinalproduct>
        <drugbatchnumb>40C813</drugbatchnumb>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLOSTAR</medicinalproduct>
        <drugbatchnumb>OF061A</drugbatchnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLOSTAR</medicinalproduct>
        <drugbatchnumb>40C813</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100708</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLOSTAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100709</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>40C813</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE:14 UNIT(S)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>OF061A</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE:14 UNIT(S)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>40C813</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE:14 UNIT(S)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100708</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE:14 UNIT(S)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100709</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugdosagetext>WITH MEALS DOSE:6 UNIT(S)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugdosagetext>UNSURE HOW MANY MEALS PATIENT REC'D A DAY. DOSE:3 UNIT(S)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugdosagetext>UNSPECIFIED DOSE GIVE AS COVERAGE IN ADDITION TO 3 UNITS WITH MEALS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>EVERY 4 HOURS ; PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>EVERY 2 HOURS ;PRN DOSE:2 PUFF(S)</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134461-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-JPNSP2010003049</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>LYOPHYLIZED 50 MG/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070706</drugenddate>
        <drugtreatmentduration>358</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>LYOPHYLIZED 25 MG/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080627</drugenddate>
        <drugtreatmentduration>351</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100528</drugenddate>
        <drugtreatmentduration>694</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100618</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060310</drugenddate>
        <drugtreatmentduration>794</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070208</drugenddate>
        <drugtreatmentduration>335</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100627</drugenddate>
        <drugtreatmentduration>1235</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NU-LOTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAVELMIN</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070626</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISCOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070511</drugenddate>
        <drugtreatmentduration>1060</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070906</drugenddate>
        <drugtreatmentduration>220</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANVITAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOVITAMINOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHADOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VERTIGO</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071026</drugenddate>
        <drugtreatmentduration>124</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMEDIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOVITAMINOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071026</drugenddate>
        <drugtreatmentduration>124</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050219</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAGAMET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134462-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-BAXTER-2010BH029030</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMOPERITONEUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134463-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13292BP</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM BROMIDE</medicinalproduct>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>5 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAT'S CLAW</medicinalproduct>
        <drugdosagetext>500 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134464-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13403NB</companynumb>
    <primarysource>
      <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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>020850</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>URIEF</medicinalproduct>
        <drugdosagetext>4 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101114</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134465-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BR-02803BR</companynumb>
    <primarysource>
      <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>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>020850</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134466-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13572BP</companynumb>
    <primarysource>
      <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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>EMPHYSEMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134470-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100316</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0034001</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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100116</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134471-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA058584</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>98.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE:35 UNIT(S)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE:25 UNIT(S)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060810</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTICLICK</medicinalproduct>
        <drugbatchnumb>419133</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070618</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134473-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-PFIZER INC-2010159809</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL AROUSAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEJA VU</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AROMASIN</medicinalproduct>
        <drugauthorizationnumb>020753</drugauthorizationnumb>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134474-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-PFIZER INC-2010160759</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECALOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugdosagetext>2 MG, 4X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>60 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPILIM</medicinalproduct>
        <drugdosagetext>200 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>200 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPNODORM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>200 MG, 4X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>50 UG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134475-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010121717</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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AFFECTIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</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>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>JOINT INJURY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>JOINT INJURY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>JOINT INJURY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134476-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160624</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPEN WOUND</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKULL FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134477-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160619</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>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134478-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-PFIZER INC-2010161050</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL ARTERY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>37.5 MG, CYCLIC</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
        <drugtreatmentduration>288</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
        <drugtreatmentduration>288</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINVACOR</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
        <drugtreatmentduration>288</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEBIVOLOL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
        <drugtreatmentduration>288</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUTIROX</medicinalproduct>
        <drugdosagetext>25 UG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
        <drugtreatmentduration>204</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134479-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010162240</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URETERIC OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101006</drugenddate>
        <drugtreatmentduration>1534</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRIC ACID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRIC ACID</medicinalproduct>
        <drugindication>BLOOD TRIGLYCERIDES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134480-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010138882</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BETA-D-GLUCAN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES INSIPIDUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOPHTHALMITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugdosagetext>350 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101027</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugdosagetext>200 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>SYSTEMIC CANDIDA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugdosagetext>150 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101125</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugdosagetext>500 MG, DAY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>CENTRAL NERVOUS SYSTEM LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101025</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
        <drugdosagetext>15 ML X 6 TO 8 TIMES, DAY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>DRUG DETOXIFICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101027</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
        <drugdosagetext>3 G, DAY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
        <drugindication>FEBRILE NEUTROPENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEYLON</medicinalproduct>
        <drugdosagetext>40 ML, 3-4 TIMES</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>DRUG DETOXIFICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101026</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEYLON</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAMOX</medicinalproduct>
        <drugdosagetext>500 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101027</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FULCALIQ</medicinalproduct>
        <drugdosagetext>1003 ML, DAY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>NUTRITIONAL SUPPORT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101027</drugenddate>
        <drugtreatmentduration>72</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BICARBON</medicinalproduct>
        <drugdosagetext>500 ML, 3-4 TIMES</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>DETOXIFICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101026</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAXIZON</medicinalproduct>
        <drugdosagetext>100 MG, 1-2 TIMES</drugdosagetext>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101026</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAXIZON</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TPN ELECTROLYTES IN PLASTIC CONTAINER</medicinalproduct>
        <drugdosagetext>500 ML, 3X/DAY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>NUTRITIONAL SUPPORT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOPTOL</medicinalproduct>
        <drugdosagetext>1 GTT, 1X/DAY</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugdosagetext>1 UNK, 1X/DAY</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZOPT</medicinalproduct>
        <drugdosagetext>1 GTT, 2X/DAY</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYALEIN</medicinalproduct>
        <drugdosagetext>1 UNK, 4-5 TIMES</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>CONJUNCTIVAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134481-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160618</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>CERVICAL VERTEBRAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134482-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010160919</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SICK SINUS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>XANTHOPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DISOPYRAMIDE</medicinalproduct>
        <drugauthorizationnumb>017447</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERBESSER ^TANABE^</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>12.5MG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>2.5MG/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134483-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010151167</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</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>AROMASIN</medicinalproduct>
        <drugauthorizationnumb>020753</drugauthorizationnumb>
        <drugdosagetext>25 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100714</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134484-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA061085</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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLOSTAR</medicinalproduct>
        <drugbatchnumb>0F224A</drugbatchnumb>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE:16 UNIT(S)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>0F224A</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE:20 UNIT(S)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134485-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA062705</companynumb>
    <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 MALFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLOSTAR</medicinalproduct>
        <drugbatchnumb>0F172A</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>0F172A</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134486-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-10P-062-0687729-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BUNION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACEMETACIN</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134487-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-JNJFOC-20101200687</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugdosagetext>DAY 1</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATRASENTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAVEGIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134488-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100611</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-JNJFOC-20100604944</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134489-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0688782-00</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>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN UNCONJUGATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020945</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATAZANAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMAN GROWTH HORMONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060131</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134490-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-AVENTIS-2010SA064340</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020496</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELBIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugdosagetext>DOSE:600 UNIT(S)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134491-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-KINGPHARMUSA00001-K201001441</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>DERMATITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugauthorizationnumb>019901</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100713</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPROPION</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100708</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134492-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-KINGPHARMUSA00001-K201001429</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMOCHROMIC NORMOCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugauthorizationnumb>019901</drugauthorizationnumb>
        <drugdosagetext>1.25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOTHYROX</medicinalproduct>
        <drugdosagetext>100 MCG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
        <drugdosagetext>400 MCG, BID</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134493-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-KINGPHARMUSA00001-K200900232</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugauthorizationnumb>019901</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugdosagetext>10 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080908</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMINEURIN</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL</medicinalproduct>
        <drugdosagetext>2.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEP</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALLORY-WEISS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080810</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIAPRIDEX</medicinalproduct>
        <drugdosagetext>1.5 BID, 1 QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TARDIVE DYSKINESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134494-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2010-41913</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugbatchnumb>EP072P0102</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134495-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2010-41930</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091218</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134496-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2010-41917</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>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134497-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2010-41389</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugbatchnumb>EP070P0103</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134498-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2010-41952</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILOPROST INHALATION SOLUTION 20UG US</medicinalproduct>
        <drugbatchnumb>01074A</drugbatchnumb>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071015</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134499-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2010-41053</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugbatchnumb>EP071P0103</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060822</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134500-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2010-41444</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>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100315</drugenddate>
        <drugtreatmentduration>654</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TADALAFIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134501-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ACTELION-A-US2010-41603</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILOPROST INHALATION ROW</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081029</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134502-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2010-41565</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PACKED RED BLOOD CELL TRANSFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugbatchnumb>DP026P0102</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CHANNEL BLOCKERS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134504-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2010-41951</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILOPROST INHALATION SOLUTION 20UG US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101122</drugenddate>
        <drugtreatmentduration>244</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134505-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2010-41507</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugbatchnumb>EP072P0102</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134506-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2010-41911</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>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugbatchnumb>EP073P0103</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101122</drugenddate>
        <drugtreatmentduration>130</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134507-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2010-38835</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 125 MG US</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 125 MG US</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134508-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2010-41535</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>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 125 MG US</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
        <drugtreatmentduration>1265</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 125 MG US</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070517</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134509-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA066332</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>DEVICE MALFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLOSTAR</medicinalproduct>
        <drugbatchnumb>0F166A</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>0F166A</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134510-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-KINGPHARMUSA00001-K201001426</companynumb>
    <primarysource>
      <reportercountry>TURKEY</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>ENDOCARDITIS CANDIDA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEPTRA</medicinalproduct>
        <drugauthorizationnumb>017376</drugauthorizationnumb>
        <drugdosagetext>160/800 MG BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRUCELLOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEPTRA</medicinalproduct>
        <drugauthorizationnumb>017376</drugauthorizationnumb>
        <drugindication>ENDOCARDITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugindication>ENDOCARDITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ENDOCARDITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFAMPICIN</medicinalproduct>
        <drugdosagetext>600 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRUCELLOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFAMPICIN</medicinalproduct>
        <drugindication>ENDOCARDITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRUCELLOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
        <drugindication>ENDOCARDITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134511-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2010-41940</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugbatchnumb>EP071P0103</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101122</drugenddate>
        <drugtreatmentduration>676</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134512-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2010-41548</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LOCALISED INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070308</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134513-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2010-41144</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>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>65 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134514-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2010-41923</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>POOR PERIPHERAL CIRCULATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090924</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134517-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-BAXTER-2010BH029086</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134518-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0034016</companynumb>
    <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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100604</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134526-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101108500</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXIL</medicinalproduct>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugdosagetext>20-35 MG/M2 OVER 1 HOUR ON ON DAY 1, 4 WEEK CYCLES.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTATIC NEOPLASM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>100-125 MG/M2 ON DAY 1 OVER 2 HOURS, 4 WEEK CYCLES</drugdosagetext>
        <drugadministrationroute>013</drugadministrationroute>
        <drugindication>METASTATIC NEOPLASM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugdosagetext>ON DAY 1, OVER 2 HOURS, 4 WEEK CYCLES</drugdosagetext>
        <drugadministrationroute>013</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>ON DAY 1 PRIOR TO CHEMOTHERAPY, 4 WEEK CYCLES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>ON DAYS 1-5 FOLLOWING CHEMOTHERAPY, 4 WEEK CYCLES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134527-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100223</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0034018</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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100217</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134530-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA071377</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>
      <patientweight>74.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101007</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101104</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVESTIGATIONAL DRUG</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVESTIGATIONAL DRUG</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN AND CLAVULANATE POTASSIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101105</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134531-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-US-EMD SERONO, INC.-7008651</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>METASTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134532-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA070456</companynumb>
    <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 MALFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLOSTAR</medicinalproduct>
        <drugbatchnumb>0F172A</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>0F172A</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134533-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010153646</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>VIOLENCE-RELATED SYMPTOM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134534-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160610</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>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE HYCLATE</medicinalproduct>
        <drugauthorizationnumb>050007</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE HYCLATE</medicinalproduct>
        <drugauthorizationnumb>050007</drugauthorizationnumb>
        <drugindication>OROPHARYNGEAL PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134535-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010150739</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134536-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010156399</companynumb>
    <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>PAINFUL DEFAECATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134537-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2010162905</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM COLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
        <drugauthorizationnumb>020987</drugauthorizationnumb>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GOLIMUMAB</medicinalproduct>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100816</drugenddate>
        <drugtreatmentduration>141</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVANE</medicinalproduct>
        <drugdosagetext>80 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugdosagetext>1 DF, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugdosagetext>1 DF, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134538-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2010162522</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugauthorizationnumb>011459</drugauthorizationnumb>
        <drugdosagetext>50 MG QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugauthorizationnumb>011459</drugauthorizationnumb>
        <drugdosagetext>100 MG QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101028</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>75 MG TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101029</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVLOCARDYL</medicinalproduct>
        <drugdosagetext>40 MG QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VARICES OESOPHAGEAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101028</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVLOCARDYL</medicinalproduct>
        <drugdosagetext>160 MG QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101030</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPECIAFOLDINE</medicinalproduct>
        <drugdosagetext>5 MG QD</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPECIAFOLDINE</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABACAVIR SULFATE/LAMIVUDINE</medicinalproduct>
        <drugdosagetext>1 DF, 1X/DAY</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABACAVIR SULFATE/LAMIVUDINE</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugdosagetext>2 DF, 1X/DAY</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134539-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-10P-062-0687780-00</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 FISTULA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>EOW</drugdosagetext>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISON</medicinalproduct>
        <drugdosagetext>MORNING:20MG,EVENING 10MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STOMACH PROTECTING MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134540-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ABBOTT-10P-150-0672728-00</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>3</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>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>H1N1 INFLUENZA VACCINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENAT</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>BEHEPAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLOROQUINE PHOSPHATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALGANEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICHEW D3</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134541-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100420</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0034010</companynumb>
    <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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100330</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134546-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13504BP</companynumb>
    <primarysource>
      <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>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134547-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091224</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0034003</companynumb>
    <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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091125</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134548-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-SANOFI-AVENTIS-2010SA070805</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>170</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WRONG DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLOSTAR</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APIDRA SOLOSTAR</medicinalproduct>
        <drugauthorizationnumb>021629</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLOSTAR</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETIC NEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19810101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134549-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-200217257US</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>
      <patientweight>57.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENZAMYCIN</medicinalproduct>
        <drugbatchnumb>MN5383</drugbatchnumb>
        <drugauthorizationnumb>050557</drugauthorizationnumb>
        <drugdosagetext>DOSE AS USED: UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENZAMYCIN</medicinalproduct>
        <drugbatchnumb>906657</drugbatchnumb>
        <drugauthorizationnumb>050557</drugauthorizationnumb>
        <drugdosagetext>DOSE AS USED: UNKNOWN</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENZAMYCIN</medicinalproduct>
        <drugbatchnumb>11813A</drugbatchnumb>
        <drugauthorizationnumb>050557</drugauthorizationnumb>
        <drugdosagetext>DOSE AS USED: UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN AND MINERAL PRENATAL SUPPLEMENT W/ FOLIC ACID CAP</medicinalproduct>
        <drugdosagetext>DOSE AS USED: 1 TABLET</drugdosagetext>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITRACAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134550-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-ASTRAZENECA-2010SE56128</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS BULLOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CAROTID ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLOPRIM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134555-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2010-41944</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugbatchnumb>EP072P0102</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101111</drugenddate>
        <drugtreatmentduration>2547</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CHANNEL BLOCKERS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134556-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2010-40368</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugbatchnumb>DP026P0102</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100909</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134557-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20101201183</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCHLORAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WATER INTOXICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEMONAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LONASEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULEPTIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMPERIDOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOXAZOLAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETIZOLAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIPERIDEN LACTATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUNITRAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134558-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101128</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010113658</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>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugauthorizationnumb>021131</drugauthorizationnumb>
        <drugdosagetext>200 MG, 2X/DAY</drugdosagetext>
        <drugindication>SKIN INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134559-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-SANOFI-AVENTIS-2010SA070751</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>4.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFAMPICIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050420</drugauthorizationnumb>
        <drugindication>TUBERCULOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFAMPICIN</medicinalproduct>
        <drugauthorizationnumb>050420</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>TUBERCULOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PYRAZINAMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>TUBERCULOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHAMBUTOL HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>TUBERCULOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugindication>RETROVIRAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugindication>RETROVIRAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOPINAVIR/RITONAVIR</medicinalproduct>
        <drugindication>RETROVIRAL INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134560-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-AVENTIS-2010SA072475</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ENTEROCOLITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugindication>LUNG SQUAMOUS CELL CARCINOMA STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100825</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134561-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006752</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>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090910</drugenddate>
        <drugtreatmentduration>1717</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134566-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ALEXION-A201001519</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA PNEUMOCOCCAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIRIS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAROXYSMAL NOCTURNAL HAEMOGLOBINURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIRIS</medicinalproduct>
        <drugdosagetext>900 MG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD AND RELATED PRODUCTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134567-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ALEXION-A201001533</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>SOLIRIS</medicinalproduct>
        <drugdosagetext>900 MG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAROXYSMAL NOCTURNAL HAEMOGLOBINURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071126</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134568-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7027535</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>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100501</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugindication>DYSTHYMIC DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VERTIGO</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SONATA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100501</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100501</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100501</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134569-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7029922</companynumb>
    <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>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134570-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PE-SANOFI-AVENTIS-2010SA072631</companynumb>
    <primarysource>
      <reportercountry>PERU</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100609</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED THERAPY</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101107</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134571-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010005444</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134573-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-AVENTIS-2010SA071512</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>0</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOSPLENOMEGALY NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBILIRUBINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL DRUGS AFFECTING FOETUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>009768</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>MYELOFIBROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>MYELOFIBROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134574-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-10P-062-0688200-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COSTOCHONDRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISDN HEXAL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAHEXAL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</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>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134575-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0684712-00</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>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPRON DEPOT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019732</drugauthorizationnumb>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134576-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-A03200903688</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>
      <patientweight>73.48</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONCUSSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST-TRAUMATIC AMNESTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN CR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021774</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN CR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021774</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021774</drugauthorizationnumb>
        <drugdosagetext>DOSE TEXT: TAKES DOSES OF 5MG OR LESS AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021774</drugauthorizationnumb>
        <drugdosagetext>DOSE TEXT: TAKES DOSES OF 7 TO 8 MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>20 MG ALTERNATING WITH 40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLGARD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AS DIRECTED (4-5 TIMES A DAY)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134577-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA76189</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091111</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134579-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010ZA79646</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>500 MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>10 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugdosagetext>30 MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIMETIDINE</medicinalproduct>
        <drugdosagetext>200 MG, TID</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134580-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP79111</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</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>20100928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugdosagetext>800 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134581-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20101108290</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PALEXIA RETARD</medicinalproduct>
        <drugauthorizationnumb>022304</drugauthorizationnumb>
        <drugdosagetext>2X 100 MG, DAILY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANSTEC PRO</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134582-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2009US66840</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE MARROW TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>500 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134583-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2010IE04596</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101008</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134584-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2009US12475</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SICKLE CELL ANAEMIA WITH CRISIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>625 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SICKLE CELL ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134585-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP79051</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 LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100917</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100925</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUNITINIB MALATE</medicinalproduct>
        <drugdosagetext>37.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100722</drugenddate>
        <drugtreatmentduration>70</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>05 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAGAMET</medicinalproduct>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS CITRATE</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON DEFICIENCY ANAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100925</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134586-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA50285</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOCTURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADALAT CC</medicinalproduct>
        <drugdosagetext>30 MG, ONE WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070906</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADALAT CC</medicinalproduct>
        <drugdosagetext>90 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADALAT CC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADALAT CC</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEPTRA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN SODIUM W/CLAVULANATE POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134587-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US64029</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEKTURNA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134588-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010FR80013</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREATININE RENAL CLEARANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTARENE LP</medicinalproduct>
        <drugauthorizationnumb>019201</drugauthorizationnumb>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100719</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100719</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>KALEORID LP</medicinalproduct>
        <drugdosagetext>1000 MG, QD</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100719</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ALDALIX</medicinalproduct>
        <drugdosagetext>50/20 MG QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100719</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IPERTEN</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100719</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARDEGIC</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134589-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010FR79701</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>OPTIC NEURITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL FIELD TESTS ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COOLMETEC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAVISCON</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOLIPRANE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134590-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2009CA17384</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCCULT BLOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>40 MG, EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ACROMEGALY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>40 MG, EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101022</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134591-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2010US18119</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEDRIN (MIGRAINE)</medicinalproduct>
        <drugauthorizationnumb>020802</drugauthorizationnumb>
        <drugdosagetext>1 DF, QID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134592-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-SANOFI-AVENTIS-2010SA072419</companynumb>
    <primarysource>
      <reportercountry>IRELAND</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>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECALOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIXED INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED THERAPY</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYNORM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100902</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134593-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US03275</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL SENSATION IN EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACQUIRED OESOPHAGEAL WEB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA OF CHRONIC DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTIGMATISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLEPHARITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IMMUNOGLOBULIN G INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BOWEN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED INTEREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE NAEVUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FULGURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA OF MALIGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERMETROPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR LENS IMPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGAMENT SPRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELOMA RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NERVE CUPPING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOPEDIC PROCEDURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERONEAL NERVE PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLASMACYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICULITIS LUMBOSACRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF REPAIR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FUSION SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOE AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VESICAL FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugdosagetext>90 MG, UNK</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060919</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPEUTICS NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT                            /00909301/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KADIAN ^KNOLL^</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUROTON</medicinalproduct>
        <drugdosagetext>400 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHYSICAL THERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEFLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugdosagetext>0.4 UNK, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugdosagetext>180 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNACORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROFURAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN ^A.L.^</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTEAL                            /03186201/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN AND MINERAL SUPP</medicinalproduct>
        <drugdosagetext>UNK, 3 PILLS A DAY TAKEN WITH BREAKFAST</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>600MG, 2 TIME A DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>20 MG, ONE TIME A DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTER-C</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGESTROL ACETATE</medicinalproduct>
        <drugdosagetext>40MG, 2 TEAS DAILY WHEN NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOSALBUTAMOL</medicinalproduct>
        <drugdosagetext>2 INHALATION FOUR TIMES A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOMETASONE FUROATE</medicinalproduct>
        <drugdosagetext>2 INHALATION FOUR TIMES A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
        <drugdosagetext>2 INHALATION FOUR TIMES A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061121</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
        <drugdosagetext>2 INHALATION FOUR TIMES A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugdosagetext>2 CAPSULES DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071121</drugenddate>
        <drugtreatmentduration>385</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUVAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PNEUMOVAX 23</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALERIAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT                                 /UNK/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134594-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHNY2010GB00540</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL (NCH)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPHENIDATE</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134595-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2010US18312</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>54.422</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>1-DAY VAGINAL OINTMENT (NCH)</medicinalproduct>
        <drugauthorizationnumb>020676</drugauthorizationnumb>
        <drugdosagetext>300 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134596-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHNY2010GB00539</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL (NCH)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPHENIDATE</medicinalproduct>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134597-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHNY2010GB00538</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL (NCH)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPHENIDATE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134598-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101107743</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSTONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugauthorizationnumb>021123</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134602-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060907</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2006AU02715</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>DRUG LEVEL CHANGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYFORTIC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134603-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20081001</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-CELGENEUS-056-21880-08100201</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070723</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOPRAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARACLINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134608-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GENZYME-POMP-1001145</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYOZYME</medicinalproduct>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLYCOGEN STORAGE DISEASE TYPE II</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100505</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134609-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2010159657</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FACTOR VIII INHIBITION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REFACTO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134610-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MYLANLABS-2010S1021405</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>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugauthorizationnumb>090868</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDICOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134611-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010DE79798</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>NEW PACKAGE OF DIOVAN 80 MG</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101004</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134612-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010SI79318</companynumb>
    <primarysource>
      <reportercountry>SLOVENIA</reportercountry>
      <qualification>1</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>ZOLEDRONATE T29581+</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4MG/5ML/28DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070829</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIPTORELIN</medicinalproduct>
        <drugdosagetext>ONCE IN 3 MONTH</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORIS (ATORVASTATIN)</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMNIC</medicinalproduct>
        <drugdosagetext>1 TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TELMISARTAN</medicinalproduct>
        <drugdosagetext>1 TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134613-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA78085</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBRIN D DIMER INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULAR FILTRATION RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOCYTE COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>3 MG EVERY 6 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugindication>METASTASES TO BONE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134614-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US79511</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TUMOUR MARKER INCREASED</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>CHEMOTHERAPEUTICS NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134615-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010AU80091</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134616-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101114</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010DE79585</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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 HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugdosagetext>1 DF DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134617-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08860</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.702</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC RETINOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOCARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEARING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOCTURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CAVITY FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERONEAL NERVE PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTERIOR CAPSULE OPACIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESBYOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRIMARY SEQUESTRUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC EMBOLUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS FLOATERS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>90 MG, ONCE/SINGLE</drugdosagetext>
        <drugindication>HYPERCALCAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030509</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>90MG MONTHLY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060724</drugenddate>
        <drugtreatmentduration>104</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4MG Q MONTH</drugdosagetext>
        <drugindication>HYPERCALCAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4MG Q MONTH</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>3 MG Q MONTH</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>2.4MG DAYS 1,4,8, AND 11 MONTHLY</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030728</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>2.4MG DAYS 1,4,8, AND 11 MONTHLY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugdosagetext>300MG DAY 1 SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>200 MG, QHS</drugdosagetext>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugdosagetext>50 MG 2-4 TABS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON #1</medicinalproduct>
        <drugdosagetext>X 4 DAYS</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN ^A.L.^</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134618-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MYLANLABS-2010S1021415</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugauthorizationnumb>018487</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLENIL MODULITE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-CODAMOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAMINE HCL</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>VITAMIN B COMPLEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134619-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2009US01770</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80.65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SERUM FERRITIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>500 MG, QID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091010</drugenddate>
        <drugtreatmentduration>662</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>2000 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON OVERLOAD</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134621-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR23464</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>80 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134622-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP78208</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134623-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP80437</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050574</drugauthorizationnumb>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134624-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010TR79079</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
    </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>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugindication>ACROMEGALY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134625-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010DE65531</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DESFERAL</medicinalproduct>
        <drugauthorizationnumb>016267</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>IRON OVERLOAD</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100919</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134626-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2009US66414</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>500 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134627-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US79468</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugdosagetext>2.5 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134628-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010MX81701</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>91</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugdosagetext>9.2 MG/24 HOUR</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134629-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GENZYME-POMP-1001210</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYOZYME</medicinalproduct>
        <drugdosagetext>20 MG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLYCOGEN STORAGE DISEASE TYPE II</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100511</drugenddate>
        <drugtreatmentduration>670</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134630-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010DE69477</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RASILEZ</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>150 MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100706</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134631-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP51773</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>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALISKIREN/AMOLODIPINE BESYLATE/HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>150 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100429</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIART</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KIPRES</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100323</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134632-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010IT02019</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>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA AT REST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RALES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED ALISKIREN ALI+TAB+CF</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>CODE NOT BROKEN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100202</drugenddate>
        <drugtreatmentduration>54</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED ENALAPRIL COMP-ENA+</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>CODE NOT BROKEN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100202</drugenddate>
        <drugtreatmentduration>54</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED NO TREATMENT RECEIVED NOMED</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>CODE NOT BROKEN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100202</drugenddate>
        <drugtreatmentduration>54</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALISKIREN</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMPARATOR ENALAPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091110</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134633-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2010GB04366</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>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugauthorizationnumb>019201</drugauthorizationnumb>
        <drugdosagetext>50 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIINFLAMMATORY THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIVAROXABAN</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>KNEE OPERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100907</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134634-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010FR74715</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>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM PQ INTERVAL PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPIDERMAL NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODYNAMIC INSTABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTIC INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXCARBAZEPINE</medicinalproduct>
        <drugauthorizationnumb>021014</drugauthorizationnumb>
        <drugindication>PARTIAL SEIZURES</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134635-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR81709</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>EXELON</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugdosagetext>9MG/5CM^2</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134636-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR23197</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>CARBAMAZEPINE</medicinalproduct>
        <drugauthorizationnumb>018927</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134637-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR25396</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>GASTRIC OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134638-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2008JP12496</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS ASSOCIATED LYMPHOPROLIFERATIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CERTICAN</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEART TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>250 MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>250 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134640-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2009TW61037</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1250 MG X 12 TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>750 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100810</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1250MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134641-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010FR80863</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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 FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugauthorizationnumb>050574</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLOOD DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134642-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US81610</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134643-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010FR80447</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DEFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RASILEZ</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>300 MG (1 TABLET DAILY)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134644-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010FR81451</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SIGMOIDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONATE T29581++BM</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134645-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP75041</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN</medicinalproduct>
        <drugauthorizationnumb>019667</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>VIPOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>VIPOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134646-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US80061</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPEUTICS NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134647-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010SE79735</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAMIDRONATE DISODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELOKEN ZOC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THACAPZOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALURES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALEORID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TROMBYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRADOLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134648-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US81294</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TERMINAL STATE</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>20100825</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134649-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-10P-062-0684169-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILE DUCT STONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>80MG IN WEEK 0; 40MG IN WEEK 2; 40MG EOW</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESALAMINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILZEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC</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>SELEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134650-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-SANOFI-AVENTIS-2010SA071815</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugauthorizationnumb>017532</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134651-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101102898</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 DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134652-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20100407909</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>40.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFLAMMATORY BOWEL DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIPLE VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134653-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101103662</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>LAST DOSE: NOV-2010</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134654-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101000930</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>OAMKA83002;OAMKA82902</drugbatchnumb>
        <drugdosagetext>12 INFUSIONS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134657-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ELI_LILLY_AND_COMPANY-BR201010003307</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134658-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011006342</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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL SELF-INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>120 MG, UNKNOWN</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>1 D/F, 2/D</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugdosagetext>500 MG, UNKNOWN</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>1 D/F, 2/D</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>1 MG, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>0.5 MG, UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134659-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011007352</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>DIABETES INSIPIDUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>021253</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DELIRIUM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134660-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011005946</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>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>021411</drugauthorizationnumb>
        <drugdosagetext>40 MG, EACH MORNING</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134661-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101120</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201010003991</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE ODOUR ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>120 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
        <drugdosagetext>15 MG, EACH EVENING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
        <drugdosagetext>30 MG, EACH EVENING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>0.5 MG, 2/D</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134662-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13398NB</companynumb>
    <primarysource>
      <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>HYPERURICAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICOMBI COMBINATION</medicinalproduct>
        <drugauthorizationnumb>021162</drugauthorizationnumb>
        <drugdosagetext>TELMISARTAN 40 MG/HYDROCHLOROTHIAZIDE 12.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATELEC</medicinalproduct>
        <drugdosagetext>1DF</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100305</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101021</drugenddate>
        <drugtreatmentduration>230</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
        <drugtreatmentduration>230</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134663-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13522BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>001496A,9D1015</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>001496A,9D1015</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101128</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134664-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MYLANLABS-2010S1021429</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACQUIRED DIAPHRAGMATIC EVENTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIAPHRAGMATIC PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALLORY-WEISS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE STIMULATION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugauthorizationnumb>075281</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CODEINE W/PARACETAMOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134665-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-595731</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030205</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134666-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MYLANLABS-2010S1021560</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>ALCOHOL POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>JATROSOM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugauthorizationnumb>076540</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134667-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MYLANLABS-2010S1021560</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>JATROSOM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugauthorizationnumb>078626</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134668-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-384576</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC FATIGUE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19910101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>STILL RECEIVING TREATMENT ON 26 JUN 2000</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134669-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-384993</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADJUSTMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA EFFLUVIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA OF CHRONIC DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCUTANEOUS FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIRECTAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSOAS ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFRACTION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBCUTANEOUS ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOPHLEBITIS SUPERFICIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>40 MG MONDAY THROUGH FRIDAY, THEN 40 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>40 MG A DAY, 80 MG TWO DAYS A WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>80 MG MONDAY, WEDNESDAY, AND FRIDAY; 40 MG TUESDAY, THRUSDAY, SATURDAY, AND SUNDAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980611</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>TAKEN AS NEEDED; NOT TAKEN REGULARLY</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOVENT</medicinalproduct>
        <drugdosagetext>TAKEN AS NEEDED; NOT TAKEN REGULARLY</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134670-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MYLANLABS-2010S1021560</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>ALCOHOL POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>JATROSOM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugauthorizationnumb>075577</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugauthorizationnumb>075577</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugauthorizationnumb>075577</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugauthorizationnumb>075577</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134671-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MYLANLABS-2010S1021560</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>JATROSOM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugauthorizationnumb>075207</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugauthorizationnumb>075207</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugauthorizationnumb>075207</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugauthorizationnumb>075207</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134672-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-479476</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICROCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEPTIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>XEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19950414</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134673-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-554661</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMIFLU</medicinalproduct>
        <drugauthorizationnumb>021087</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>EACH MORNING.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TRANSIENT ISCHAEMIC ATTACK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMINYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ CODEINE</medicinalproduct>
        <drugdosagetext>2 TIMES MORNING, 1 TIMES AT NOON AND 2 TIMES HS.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PILOCARPINE</medicinalproduct>
        <drugdosagetext>DRUG: PILOCARPINE/ISOPTOCARPINE. ROUTE: OCCULAR. TDD: ONE DROP QID RIGHT EYE.</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOLOL</medicinalproduct>
        <drugdosagetext>ROUTE: OCCULAR. 1 DROP EACH EYE BID.</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugdosagetext>2.5 MG IN THE MORNING AND 5 MG IN THE EVENING.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134675-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MYLANLABS-2010S1021567</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERAMMONAEMIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INBORN ERROR OF METABOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugauthorizationnumb>077254</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</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>2</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSPHENYTOIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134676-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-610288</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>42.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTRIGLYCERIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080725</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080822</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081030</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081225</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugdosagetext>DRUG DISCONTINUED.</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090319</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090513</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080713</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080423</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METALCAPTASE</medicinalproduct>
        <drugdosagetext>DRUG REPORTED: METALCAPTASE (D-PENICILLAMINE).</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METALCAPTASE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080719</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METALCAPTASE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080720</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TASUOMIN</medicinalproduct>
        <drugdosagetext>DRUG REPORTED: TASUOMIN (TAMOXIFEN CITRATE)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYDOXAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
        <drugdosagetext>DRUG REPORTED: PARIET (SODIUM RABEPRAZOLE)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugdosagetext>FORM: PERORAL AGENT.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>DRUG REPORTED: FOSAMAC 5 MG(ALENDRONATE SODIUM HYDRATE)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEZAFIBRATE</medicinalproduct>
        <drugdosagetext>DRUG REPORTED: BEZATATE (BEZAFIBRATE)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>FORM: SUSTAINED RELEASE CAPSULE.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>FORM: PERORAL AGENT.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STARSIS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIMATIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090203</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134677-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-615874</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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1500 MG, Q21D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090109</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1500 MG, Q21D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090109</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>LAST DOSE RECEIVED.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPOTECAN HCL</medicinalproduct>
        <drugdosagetext>41.25 MG, QDX5D/21DC</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090113</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPOTECAN HCL</medicinalproduct>
        <drugdosagetext>41.25 MG, QDX5D/21DC</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090113</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYL SALICYLIC ACID USP BAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RALOXIFENE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
        <drugdosagetext>REPORTED:DIPHENHYDRAMINE HYDROCHLORIDE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENOXYLATE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134678-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MYLANLABS-2010S1021632</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUETIAPINE FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVERDOSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugauthorizationnumb>090514</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVERDOSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVERDOSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVERDOSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134679-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MYLANLABS-2010S1021632</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUETIAPINE FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVERDOSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVERDOSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugauthorizationnumb>070317</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVERDOSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVERDOSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134680-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100421</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-717163</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134681-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-SANOFI-AVENTIS-2010SA071826</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugauthorizationnumb>020496</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134682-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100624</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-717167</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134683-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MYLANLABS-2010S1021632</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUETIAPINE FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVERDOSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugauthorizationnumb>071405</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVERDOSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVERDOSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVERDOSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134684-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100420</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-717207</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134685-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100421</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-717281</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134686-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MYLANLABS-2010S1021754</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>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugauthorizationnumb>075973</drugauthorizationnumb>
        <drugdosagetext>USE STATED AS LONG-TERM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCET                             /01554201/</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134687-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MYLANLABS-2010S1021754</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>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugauthorizationnumb>075969</drugauthorizationnumb>
        <drugdosagetext>USE STATED AS LONG-TERM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCET                             /01554201/</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134688-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-719597</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>DRUG REPORTED AS XELODA 300, 2 WEEKS ADMINISTRATION FOLLOWED BY 1 WEEK REST</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAIXAN</medicinalproduct>
        <drugauthorizationnumb>017581</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100414</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>DRUG REPORTED: PREDOHAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELPLAT</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100423</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRANDOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT CC</medicinalproduct>
        <drugdosagetext>FORM: SUSTAINED RELEASE TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERMION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLOW-FE</medicinalproduct>
        <drugdosagetext>FORM: SUSTAINED RELEASE TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134689-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-TEVA-257075ISR</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZILECT</medicinalproduct>
        <drugauthorizationnumb>021641</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROTIGOTINE</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134691-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HR-TEVA-257387ISR</companynumb>
    <primarysource>
      <reportercountry>CROATIA (local name: Hrvatska)</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugauthorizationnumb>065150</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091212</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134692-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-722258</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>41.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXALT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIRTH CONTROL PILLS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>OCCASIONALLY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134694-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20100702282</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.67</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMPONI</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTHROTEC</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCARDIA XL</medicinalproduct>
        <drugindication>RAYNAUD'S PHENOMENON</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugindication>MULTIPLE ALLERGIES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NUCYNTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134695-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-JNJFOC-20101109022</companynumb>
    <primarysource>
      <reportercountry>GREECE</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>PNEUMONIA PRIMARY ATYPICAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMPONI</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XERISTAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134696-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MYLANLABS-2010S1021769</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>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTINUOUS HAEMODIAFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRONTOTEMPORAL DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERAMMONAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugdosagetext>125 X 500MG TABLETS; TOTAL DOSE }1000 MG/KG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTENTIONAL OVERDOSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugauthorizationnumb>074046</drugauthorizationnumb>
        <drugindication>INTENTIONAL OVERDOSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIAPRIDE</medicinalproduct>
        <drugindication>INTENTIONAL OVERDOSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134697-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-722555</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA NODOSUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL HERPES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19930101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134698-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-722581</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYODERMA GANGRENOSUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SKIN MASS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134699-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-729133</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE NODULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2A</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134700-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ROCHE-733878</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>100</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE MB INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugbatchnumb>B0010</drugbatchnumb>
        <drugdosagetext>FORM VIAL, PERMANENTLY DISCONTINUED.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>DRUG REPORTED AS LEVOTIROXINE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134701-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MYLANLABS-2010S1021769</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>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTINUOUS HAEMODIAFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERAMMONAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugdosagetext>125 X 500MG TABLETS; TOTAL DOSE }1000 MG/KG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTENTIONAL OVERDOSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugauthorizationnumb>074046</drugauthorizationnumb>
        <drugindication>INTENTIONAL OVERDOSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIAPRIDE</medicinalproduct>
        <drugindication>INTENTIONAL OVERDOSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134702-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-620131</companynumb>
    <primarysource>
      <reportercountry>NIGERIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>32</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IMMUNOGLOBULIN E INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CACHEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAFT DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIV INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR ICTERUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE COLOUR ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>050759</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NELFINAVIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANTIRETROVIRAL THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NELFINAVIR</medicinalproduct>
        <drugdosagetext>RESTARTED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CO-TRIMOXAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANTIRETROVIRAL THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CO-TRIMOXAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIRETROVIRAL THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugdosagetext>RESTARTED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIRETROVIRAL THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugdosagetext>RESTARTED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANTIRETROVIRAL THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIRETROVIRAL THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANTIRETROVIRAL THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RALTEGRAVIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KIVEXA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134703-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA072264</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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>OFO74A</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE:85 UNIT(S)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>OFO01A</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE:85 UNIT(S)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>10-30 UNITS FOUR TIMES A DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134704-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-670156</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>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>LARGE INTESTINE CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELPLAT</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>5-FU</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFOLINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>NOTE : A DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134705-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MYLANLABS-2010S1021769</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>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTINUOUS HAEMODIAFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERAMMONAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugdosagetext>125 X 500MG TABLETS; TOTAL DOSE }1000 MG/KG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTENTIONAL OVERDOSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugauthorizationnumb>074215</drugauthorizationnumb>
        <drugindication>INTENTIONAL OVERDOSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIAPRIDE</medicinalproduct>
        <drugindication>INTENTIONAL OVERDOSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134706-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-680544</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>PATHOGEN RESISTANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMIFLU</medicinalproduct>
        <drugauthorizationnumb>021087</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFLUENZA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091224</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134707-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA072370</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>BRAIN INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE:65 UNIT(S)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTICLICK</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTICLICK</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134708-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-VALEANT-2010VX001818</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>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES SIMPLEX OPHTHALMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL TEAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIMOPTIC</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACYCLOVIR SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EYE INFECTION VIRAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134709-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-683132</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAL FISSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEILITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041030</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMNESTEEM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMNESTEEM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050221</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134710-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-694138</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHLEBITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugbatchnumb>M9A41M9BB1</drugbatchnumb>
        <drugdosagetext>DOSAGE FORM: 8 MG/KG, LAST DOSE: 18 MARCH 2010, FORM: INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100415</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>EVERY WEEK, LAST DOSE: 25 MARCH 2010</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100415</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE 10</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100326</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100407</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134713-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-708641</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugbatchnumb>B1129</drugbatchnumb>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugdosagetext>FORM:PILL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134714-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-722547</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APHTHOUS STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROVESICAL FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19920101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19940101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO TRI-CYCLEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134715-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-722624</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYODERMA GANGRENOSUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>RECEIVED FOR SIX MONTHS</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19860101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134716-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-722712</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020301</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134717-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-AVENTIS-2010SA072462</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>APHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APIDRA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021629</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLOSTAR</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLOSTAR</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGLAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN DETEMIR</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134718-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-722751</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134719-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010GB32283</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>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</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>20020716</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON SUPPLEMENTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIPIPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAXATIVES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134720-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US12158</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CACHEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAILURE TO THRIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL MOTILITY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMOBILE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROGENIC BLADDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ONYCHOMYCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TESTIS CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOPHLEBITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSURETHRAL PROSTATECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENA CAVA FILTER INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WALKING DISABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070820</drugenddate>
        <drugtreatmentduration>1364</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NILANDRON</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPURIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENOFER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugdosagetext>50 UG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAPTOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL ^ACHE^</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134721-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US78815</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLINERGIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL SOUNDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIVASTIGMINE</medicinalproduct>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugdosagetext>4.6 MG, QD</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIVASTIGMINE</medicinalproduct>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugdosagetext>9 PATCHES</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134723-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-722943</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860101</drugstartdate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19921101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134724-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA072613</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE:30 UNIT(S)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTICLICK</medicinalproduct>
        <drugbatchnumb>N262</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134725-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-ROCHE-723846</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIEULAFOY'S VASCULAR MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PORTAL VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugdosagetext>FORM: INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070807</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100810</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugdosagetext>FORM: INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>DOSE AND FREQUENCY: NOT REPORTED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100828</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESPUMISAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENCORTON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTRIAXON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMETHICONE</medicinalproduct>
        <drugdosagetext>DRUG: SIMETICONUM</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100826</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100823</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100828</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugdosagetext>ROUTE: INTRAOSSEOUS (IO) ROUTE</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSUM</medicinalproduct>
        <drugdosagetext>PRN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100828</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100828</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100829</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDUM</medicinalproduct>
        <drugdosagetext>TDD: 10 UG/N</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUMIN (HUMAN)</medicinalproduct>
        <drugdosagetext>DRUG: ALBUMIN 20%</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100829</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100829</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>TDD: 8ML/HOUR</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLASMA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PETHIDINE</medicinalproduct>
        <drugdosagetext>DRUG: PETYDINI</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100830</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134726-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US11591</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80.272</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAPILLARY LEAK SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAMILY STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL RECESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULAR FILTRATION RATE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBARIC OXYGEN THERAPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAMEDULLARY ROD INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KYPHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT ATRIAL DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE MARROW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO SPINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEITIS DEFORMANS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOLOGICAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYPECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRIMARY SEQUESTRUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRISMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>90MG Q4WK</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, QMO</drugdosagetext>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4MG QW</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4MG Q3WK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050413</drugenddate>
        <drugtreatmentduration>414</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>UNK, QW3</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>20MG BID</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
        <drugdosagetext>20MG QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugdosagetext>20MG QD</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40GM BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR</medicinalproduct>
        <drugdosagetext>20 MEQ BID</drugdosagetext>
      </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>4MG/KG LOADING DOSE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>2MG/KG, EVERY WEEK</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>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>XANAX</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>75MG/M2 Q3WK</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>PREDNISONE</medicinalproduct>
        <drugdosagetext>5MG POST TAXOL INFUSION</drugdosagetext>
      </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>TYLENOL W/ CODEINE</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VACCINE BREAST CANCER PROTOCOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYBAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEFLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINERALS NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</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>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051019</drugstartdate>
      </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>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>OEDEMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134727-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-724630</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHTHOUS STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CUSHINGOID</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL FISSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>STOP DATE: 10 SEP/OCT 2002</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STEROID NOS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
        <drugdosagetext>3 TABLETS DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134728-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-729607</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BASILAR ARTERY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN STEM INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBELLAR INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBARACHNOID HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTEBRAL ARTERY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACTEMRA</medicinalproduct>
        <drugdosagetext>SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100819</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134729-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ROCHE-731764</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLORECTAL CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>B6004</drugbatchnumb>
        <drugdosagetext>LAST DOSE PRIOR TO SAE: 23 SEPTEMBER 2010, TEMPORARILY INTERRUPTED, FORM: INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>FORM: BOLUS, LAST DOSE PRIOR TO SAE: 21 SEPTEMBER 2010, TEMPORARILY INTERRUPTED</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>DOSAGE FORM: INFUSION.</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
        <drugdosagetext>TEMPORARILY INTERRUPTED. LAST DOSE PRIOR TO SAE: 21 SEPTEMBER 2010, FORM: INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugdosagetext>LAST DOSE PRIOR TO SAE: 21 SEPTEMBER 2010, TEMPORARILY INTERRUPTED, FORM: INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTINA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLARAMINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100906</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134730-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA072710</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEVICE BREAKAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE MALFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLOSTAR</medicinalproduct>
        <drugbatchnumb>0F183A</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134733-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-737156</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134734-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ROCHE-737795</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASTUZUMAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100507</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090416</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090416</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090416</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090416</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100507</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINORELBINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANIL</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BONE PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100613</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134735-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006981</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PLATELET DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091127</drugenddate>
        <drugtreatmentduration>317</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134736-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-740336</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>FORM: INFUSION</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134737-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-743099</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134738-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-734034</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>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULAR PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugdosagetext>FORM: INFUSION; STRENGTH: 200MG/10ML (20MG/ML) SOLUTION; DOSE: 8 MG/KG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100609</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugdosagetext>DOSE: 8MG/KG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100707</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugdosagetext>DOSE: 8 MG/KG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100816</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugdosagetext>DOSE: 8 MG/KG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARMOUR THYROID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLECALCIFEROL</medicinalproduct>
        <drugdosagetext>DOSE: 1000 UNITS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLVITE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134739-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ROCHE-738916</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2A</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORECORMON</medicinalproduct>
        <drugdosagetext>DOSE: 30000</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100511</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134740-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-10P-087-0686530-00</companynumb>
    <primarysource>
      <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>FENOFIBRATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019304</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134741-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0685069-00</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 BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020945</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA D 24 HOUR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990715</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101011</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134742-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-739575</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAPILLOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>REDUCED DOSAGE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugdosagetext>REDUCED DOSAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101012</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134743-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-EISAI INC.-E2090-00923-SPO-DE</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>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZONEGRAN</medicinalproduct>
        <drugauthorizationnumb>020789</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZONEGRAN</medicinalproduct>
        <drugauthorizationnumb>020789</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOREM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZBROMARON</medicinalproduct>
        <drugdosagetext>1 TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XIPAMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLITHOM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134744-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-739891</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugbatchnumb>U601101, U9408</drugbatchnumb>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>900 UNK, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugbatchnumb>R402825</drugbatchnumb>
        <drugdosagetext>1250 UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101031</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134745-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ROCHE-740139</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>114</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GTN SPRAY</medicinalproduct>
        <drugdosagetext>FREQUENCY: PRN</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134746-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>LB-GENENTECH-302668</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>VASCULITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134747-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-740140</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugdosagetext>INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>EVERYDAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AORTIC VALVE REPLACEMENT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134749-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006799</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134750-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ROCHE-741250</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>ENDOPHTHALMITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>INTRAVITREOUS ROUTE</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MYOPIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100122</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134751-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GENENTECH-310103</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COAPROVEL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LERCANIDIPINE</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>7134752-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20081008</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-742412</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134753-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-742901</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OSELTAMIVIR</medicinalproduct>
        <drugauthorizationnumb>021087</drugauthorizationnumb>
        <drugdosagetext>FORMATION NOT OTHERWISE SPECIFIED.</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>INFLUENZA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100110</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134754-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-310121</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK MG/M2, Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLERIXAFOR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134755-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EE-ROCHE-743211</companynumb>
    <primarysource>
      <reportercountry>ESTONIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDROTHORAX</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>FREQUENCY: 3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100819</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134756-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-743501</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101120</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134757-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GENENTECH-310063</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>375 MG, Q2W</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101027</drugenddate>
        <drugtreatmentduration>1611</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134758-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-ROCHE-743716</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>3</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>MIRCERA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100925</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134759-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PK-ROCHE-744079</companynumb>
    <primarysource>
      <reportercountry>PAKISTAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2A</medicinalproduct>
        <drugdosagetext>DATE OF LAST DOSE PRIOR TO SAE:17 NOVEMBER 2010. PERMANENTLY DISCONTINUED</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101123</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134760-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP20773</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTICONVULSANT DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTICONVULSANT DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>500 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>LOW DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100923</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERO-GRADUMET</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADETPHOS</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MERISLON</medicinalproduct>
        <drugdosagetext>12 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOCOID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIRUDOID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134761-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-ROCHE-744171</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
        <drugauthorizationnumb>021238</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ANTIDEPRESSANT NOS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134762-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-744309</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACUTAN</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134763-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-ROCHE-744348</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100426</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134764-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-744418</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>34.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRAIN STEM GLIOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLIPPERY ELM</medicinalproduct>
        <drugdosagetext>FREQ: 1/2 TEASPON 2X DAY.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>L-CARNITINE</medicinalproduct>
        <drugdosagetext>DRUG: CARNITINE (1.7 GM/TSP). FREQ: 1 TEASPON 2X DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BOSWELLIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHODIOLA ROSEA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARNICA</medicinalproduct>
        <drugdosagetext>DRUG: ARNICA 30 C PELLETS AWAY FROM FOOD.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIO C</medicinalproduct>
        <drugdosagetext>BIO C WITH FLAVANOIDS 1/2 2 X DAY.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUTAMINE</medicinalproduct>
        <drugdosagetext>GLUTAMINE (3 GM/TSP) ( 4.8 GM/TSP) 1 TEASPOON 3X DAY.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134765-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101005347</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>MALIGNANT MELANOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBIDOPA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134766-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-744614</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACUTAN</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134767-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-737071</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALVEOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugdosagetext>560 MG ALSO GIVEN ON 19 AUG 2010 AND 09 SEP 2010</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOHEXAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HCT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORASEMID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APROVEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JODID 200</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM/VITAMIN D3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NON-STEROIDAL ANTI-INFLAMMATORIES</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134769-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-744037</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>HAEMORRHAGIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100812</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100617</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100617</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100617</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134770-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ROCHE-744075</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRALEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPREX</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETUMINA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IDALPREM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>DRUG NAME: SEROQUEL PROLONG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLURAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134771-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13480BP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134772-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-DE-06617GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY MASS INDEX DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPERIOR MESENTERIC ARTERY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISACODYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134773-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-744914</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INITIAL INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CONTRACTIONS INVOLUNTARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LARIAM</medicinalproduct>
        <drugauthorizationnumb>019591</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134774-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-744979</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMIFLU</medicinalproduct>
        <drugauthorizationnumb>021087</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134775-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-ROCHE-744983</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101029</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134777-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006803</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>ENBREL</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134778-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CZ-ROCHE-745053</companynumb>
    <primarysource>
      <reportercountry>CZECH REPUBLIC</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>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134780-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-745063</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugdosagetext>FORM: INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134781-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-745148</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS CLOSTRIDIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ADENOCARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOLFIRI REGIMEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ADENOCARCINOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134782-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-745200</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134783-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070514</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-745229</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL SEPTUM PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134784-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-CELGENEUS-008-20785-10112960</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugauthorizationnumb>020785</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134785-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040930</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-745237</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134786-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006857</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POISONING DELIBERATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134787-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070514</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-745286</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134788-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080318</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-745326</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIHYDROPYRIMIDINE DEHYDROGENASE DEFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134789-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-10P-087-0687870-00</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>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019304</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091201</drugenddate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134790-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-10P-062-0687492-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>B-BLOCKER</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>CELEBREX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134791-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-745337</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPOTECAN</medicinalproduct>
        <drugdosagetext>FIRST TWO CYCLES</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPOTECAN</medicinalproduct>
        <drugdosagetext>FOR 5 CONSECUTIVE DAYS ON DAYS 1-5.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN ASPART</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN GLARGINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHERATUSSIN AC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134793-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-745447</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>
      <patientweight>108.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLIOBLASTOMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED BEVACIZUMAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAMPTOSAR</medicinalproduct>
        <drugdosagetext>LAST DOSE: 10 NOVEMNER 2010. TOTAL DOSE: 300 MG.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMOZOLOMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMOZOLOMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134794-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070402</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-745467</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>
        <drugdosagetext>DOSE, FORM AND FREQUENCY NOT PROVIDED.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134795-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-745468</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRCERA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134796-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050610</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-745483</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134797-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20081008</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-745506</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>HERCEPTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134798-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070606</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-745536</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134799-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-744763</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DERMAL CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134800-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-744821</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134801-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090330</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-745193</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EMBOLISM ARTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134802-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090302</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-745210</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134803-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101007417</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>CONTRAINDICATION TO MEDICAL TREATMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugdosagetext>500/50 IN 1 PUFF</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134804-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20100210006</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLESTATIC LIVER INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAVANIC</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLEXANE</medicinalproduct>
        <drugbatchnumb>9C0152</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMBOLEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>FOOT OPERATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134805-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20101108646</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAVANIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAVANIC</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORBENINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELISOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVONORM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARDEGIC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134806-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101108205</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOZ FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugbatchnumb>0920044</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134807-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20101108828</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>PRODUCT ADHESION ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134809-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-745323</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugauthorizationnumb>017533</drugauthorizationnumb>
        <drugdosagetext>CO-INDICATION:INSOMNIA, TAKES HALF TABLET INSTEAD OF ONE TABLET DAILY (MEDICATION ERROR)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMETIRAL</medicinalproduct>
        <drugdosagetext>DRUG REPORTED AS EMETRIL, CO-INDICATION:MUSCLE PAIN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134810-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10101407</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>COLON CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101011</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134811-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2010GB13297</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE CELL CARCINOMA OF THE RESPIRATORY TRACT STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE (NGX)</medicinalproduct>
        <drugauthorizationnumb>090029</drugauthorizationnumb>
        <drugdosagetext>30 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugdosagetext>40 MG 1/2 WEEKS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACITRETIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134812-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2010DE13291</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALCOHOL POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MECHANICAL VENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESUSCITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugauthorizationnumb>075049</drugauthorizationnumb>
        <drugdosagetext>10 MG/DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugauthorizationnumb>075049</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>SERTRALINE (NGX)</medicinalproduct>
        <drugdosagetext>150 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>TRANYLCYPROMINE SULFATE</medicinalproduct>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>TYRAMINE</medicinalproduct>
        <drugdosagetext>TYRAMINE-RICH FOOD: RED WINE, AGED CHEESE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134813-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2010FR13325</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>VASCULAR PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugauthorizationnumb>075968</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101015</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugdosagetext>4.2 MG/10.5 CM2</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101014</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFERALGAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101015</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFERALGAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101017</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYL SALICYLIC ACID USP BAT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYL SALICYLIC ACID USP BAT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101017</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACEBUTOLOL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACEBUTOLOL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRICANYL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRICANYL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101019</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYSANXIA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYSANXIA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101019</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULCOLAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUFLOMEDIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100928</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134814-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2010GB13295</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>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA FACIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMAGNESAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>075757</drugauthorizationnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100927</drugenddate>
      </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>CANDESARTAN</medicinalproduct>
        <drugdosagetext>8 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134815-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2010US13265</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>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFAZOLIN (NGX)</medicinalproduct>
        <drugauthorizationnumb>062831</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134816-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060922</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-745404</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BILIARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134817-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100906</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-745596</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugdosagetext>FORM:INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134818-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070301</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-745598</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>DOSE, FORM AND FREQUENCY NOT PROVIDED.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134819-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-745614</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134820-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20101200659</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>URINARY BLADDER RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134821-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20101200751</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugauthorizationnumb>021346</drugauthorizationnumb>
        <drugdosagetext>MAR-2010(OR APR-2010)</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ABNORMAL BEHAVIOUR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134823-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20100803712</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUSPICIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugbatchnumb>ACSK000</drugbatchnumb>
        <drugauthorizationnumb>021346</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugdosagetext>FOR APPROXIMATELY TWO YEARS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134824-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HR-JNJFOC-20101108718</companynumb>
    <primarysource>
      <reportercountry>CROATIA (local name: Hrvatska)</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPOLEPT CONSTA</medicinalproduct>
        <drugauthorizationnumb>021346</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134825-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>NL-JNJFOC-20101103571</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>NIPPLE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugauthorizationnumb>021121</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134826-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-JNJFOC-20101108711</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <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>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHINITIS ALLERGIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134827-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-JNJFOC-20101107905</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPHENIDATE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPHENIDATE HCL</medicinalproduct>
        <drugauthorizationnumb>021121</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134828-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>ES-JNJFOC-20100903524</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>43</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS CEREBRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIITH NERVE PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL FIELD DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugauthorizationnumb>021121</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134829-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101128</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-JNJFOC-20101200052</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>SELF INJURIOUS BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLUGGISHNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MUTABON</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENTELAN</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLADIO</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134830-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-JNJFOC-20101107704</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AKATHISIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugauthorizationnumb>021999</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATINA</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROSORBIDE</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134831-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101200337</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134832-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101109023</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134833-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101103426</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.77</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISION SITE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUPUS-LIKE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>ON THERAPY FOR 4 YEARS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134835-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101200176</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FREQUENT BOWEL MOVEMENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PUSTULAR</reactionmeddrapt>
      </reaction>
      <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>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134836-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101200291</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>BRONCHIECTASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134837-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-CELGENEUS-114-21880-10081492</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>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100804</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134838-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10120115</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>15-10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100611</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100923</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134842-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-745644</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>CYSTITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALGANCICLOVIR</medicinalproduct>
        <drugauthorizationnumb>021304</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CYTOMEGALOVIRUS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100302</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAKTAR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091207</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134843-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10110708</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 MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME TRANSFORMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100922</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134844-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10101828</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 MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME TRANSFORMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134845-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090504</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-745592</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON</medicinalproduct>
        <drugdosagetext>DRUG NAME REPORTED AS: INTERFERON, ROUTE: INJECTION</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134851-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10090963</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 MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME TRANSFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134852-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13000BP</companynumb>
    <primarysource>
      <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>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugdosagetext>15 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROSTAT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134853-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20100707730</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57.61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SJOGREN'S SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE DENSITY ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RELPAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134854-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20100703159</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.03</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>11 INFUSIONS ON UNSPECIFIED DATES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>FREQUENCY EVERY 6-8 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134855-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20101106870</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>OVARIAN NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GOLIMUMAB</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOHRUS TAPE</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOHRUS TAPE</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIN OD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134856-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20101200226</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>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugindication>PNEUMOCYSTIS JIROVECI PNEUMONIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134857-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20100505778</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>6TH DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUETIAPINE FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134864-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-12581765</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>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELOSEF</medicinalproduct>
        <drugauthorizationnumb>061764</drugauthorizationnumb>
        <drugdosagetext>(1G) 250MG QDS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040122</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134865-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-14645568</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</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090507</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090507</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AXITINIB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugindication>MUCOSAL INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090507</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMEBORO</medicinalproduct>
        <drugindication>RASH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090429</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN SLIDING SCALE</medicinalproduct>
        <drugdosagetext>INSULIN SLIDING SCALE</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090414</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE HCL</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugdosagetext>INHALED PUFFS</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>OXYGEN SATURATION DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090414</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
        <drugindication>RASH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090420</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugdosagetext>1 D.F= 5/500 MG</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090414</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090507</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134866-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15414410</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>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134867-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-BRISTOL-MYERS SQUIBB COMPANY-15399660</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</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>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEPHRADINE</medicinalproduct>
        <drugauthorizationnumb>061764</drugauthorizationnumb>
        <drugdosagetext>1G (8D);ALSO TAKEN 7D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEPHRADINE</medicinalproduct>
        <drugauthorizationnumb>061764</drugauthorizationnumb>
        <drugdosagetext>1G (8D);ALSO TAKEN 7D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CELLULITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugauthorizationnumb>012142</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugindication>PEPTIC ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
        <drugindication>GOUT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>GOUT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFINPYRAZONE</medicinalproduct>
        <drugindication>GOUT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISORDIL</medicinalproduct>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMIDAPRIL HCL</medicinalproduct>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134868-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15413446</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>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>009218</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
        <drugdosagetext>80MG BEFORE SEP2009</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100804</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICYCLOMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICYCLOMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZTREONAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTAVIS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134869-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15414568</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIAL OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugauthorizationnumb>009218</drugauthorizationnumb>
        <drugdosagetext>STARTED BEFOR 32 YEARS</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134871-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-BRISTOL-MYERS SQUIBB COMPANY-15418163</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>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEPHRADINE</medicinalproduct>
        <drugauthorizationnumb>061764</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134872-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-15415417</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134873-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-BRISTOL-MYERS SQUIBB COMPANY-15418171</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>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
        <drugauthorizationnumb>062987</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134874-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENZYME-CLOF-1001331</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIRUBIN CONJUGATED INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY SYNCYTIAL VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOFARABINE</medicinalproduct>
        <drugbatchnumb>09-001132</drugbatchnumb>
        <drugauthorizationnumb>021673</drugauthorizationnumb>
        <drugdosagetext>66 MG, QDX5</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101115</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>165 MG, QDX5</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101115</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>725 MG, QDX5</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101115</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>15 MG, ONCE</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SARNA</medicinalproduct>
        <drugdosagetext>0.5 %, PRN</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DRY SKIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROBITUSSIN A-C</medicinalproduct>
        <drugdosagetext>5 ML, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugdosagetext>50 MG, PRN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUTONIN</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101125</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
        <drugdosagetext>325 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101127</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMLA</medicinalproduct>
        <drugdosagetext>2.50 %, UNK</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE ALLERGIES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugdosagetext>1 MG, PRN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101127</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALMOSEPTINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DRY SKIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMEROL</medicinalproduct>
        <drugdosagetext>25 MG, PRN</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>CHILLS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101120</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUCERIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DRY SKIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>2 MG, PRN</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101127</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugdosagetext>8 MG, PRN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugdosagetext>24 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugdosagetext>17 G, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
        <drugdosagetext>21.5 MG, PRN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugdosagetext>160 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40 MG, PRN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIURETIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-CORTEF</medicinalproduct>
        <drugdosagetext>165 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101115</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
        <drugdosagetext>7.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101113</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERSED</medicinalproduct>
        <drugdosagetext>15 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101120</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101113</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTAZ</medicinalproduct>
        <drugdosagetext>2000 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANTI-INFECTIVE THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101117</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
        <drugdosagetext>600 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANTI-INFECTIVE THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICAFUNGIN</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANTIFUNGAL TREATMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugdosagetext>24 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101120</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POSACONAZOLE</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101117</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLUTIONS FOR PARENTERAL NUTRITION</medicinalproduct>
        <drugdosagetext>2160 ML, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MEDICAL DIET</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101125</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HCL</medicinalproduct>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>AGITATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101125</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugdosagetext>12.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIURETIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101113</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134876-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI022891</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>METASTATIC SQUAMOUS CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100315</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134880-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20100907189</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>51.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTOCORT EC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESALAMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTOBACILLUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134881-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20101200391</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>REBOUND EFFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134882-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GENENTECH-306631</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>VITILIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100826</drugenddate>
        <drugtreatmentduration>295</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134883-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041154</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134884-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-GENENTECH-310269</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>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>500 MG/ML, 1/MONTH</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100209</drugenddate>
        <drugtreatmentduration>239</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>250 MG/M2, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>25 MG/M2, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>500 MG, QOD</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100827</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>300 A?G, QOD</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTRIMOXAZOLE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090603</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACFOL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090603</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100817</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134885-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GENENTECH-310305</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMALIZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>150 MG, Q2W</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100409</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMALIZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK MG, Q2W</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100424</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100528</drugenddate>
        <drugtreatmentduration>240</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100508</drugenddate>
        <drugtreatmentduration>220</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134887-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GENENTECH-310309</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>150 MG, 1/MONTH</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100312</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134889-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-HQWYE246620JUL04</companynumb>
    <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>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OGEN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134890-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-US-WYE-H18456910</companynumb>
    <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>PROTONIX</medicinalproduct>
        <drugauthorizationnumb>020987</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENALOG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134891-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE201011003617</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugindication>BRONCHIOLOALVEOLAR CARCINOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134892-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-BRISTOL-MYERS SQUIBB COMPANY-15059371</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>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>ON DAY 1 OF CYCLE CISPLATIN (80 MG/M2) AS 1 TO 4 HR INF ON THE 1ST DAY OF EACH 3-WEEK CYCLE.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100316</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>ON DAY 1-15;RECENT  FIRST INF ON 28MAR2010;TEMPORARILT DISCONTINUED ON 28MAR2010</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100328</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134895-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRACCO-003897</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVENTILATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROHANCE</medicinalproduct>
        <drugbatchnumb>V9631</drugbatchnumb>
        <drugauthorizationnumb>020131</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LIVER SCAN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100826</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROHANCE</medicinalproduct>
        <drugbatchnumb>V9631</drugbatchnumb>
        <drugauthorizationnumb>020131</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HAEMANGIOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100826</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134896-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRACCO-004293</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>
      <patientweight>67</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTOID SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROHANCE</medicinalproduct>
        <drugbatchnumb>V9632</drugbatchnumb>
        <drugauthorizationnumb>020131</drugauthorizationnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>DIAGNOSTIC PROCEDURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROHANCE</medicinalproduct>
        <drugbatchnumb>V9632</drugbatchnumb>
        <drugauthorizationnumb>020131</drugauthorizationnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134897-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-JNJFOC-20101101179</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>USTEKIMUMAB</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>USTEKIMUMAB</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALIMUMAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134903-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010108288</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugauthorizationnumb>020334</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134904-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2008037098</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS PNEUMOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugauthorizationnumb>050670</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugdosagetext>EVERY DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOLIPRANE</medicinalproduct>
        <drugdosagetext>EVERY DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN TRIHYDRATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFPODOXIME PROXETIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071218</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134905-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ABBOTT-10P-114-0663669-00</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNOUT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NEURITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100727</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE/TOBRAMYCINE EYE DROPS</medicinalproduct>
        <drugdosagetext>1/3 MG/ML-5MG FLASK</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>PANOPHTHALMITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTRAN 70/HYPROMELLOSE EYE DROPS</medicinalproduct>
        <drugdosagetext>1/3MG/ML-15 ML FLASK: 1 DROP 1 - 4 TIMES DAILY</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRINOVUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUSIDINIC ACID EYE GEL</medicinalproduct>
        <drugdosagetext>10 MG/G - 5 G TUBE</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXOCOBALAMINE</medicinalproduct>
        <drugdosagetext>500 MCG/ML - 2 ML AMPOULE, ONCE EVERY 8 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>VITAMIN B12</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESALAZINE</medicinalproduct>
        <drugdosagetext>500 MG  2 TABLETS 3 X DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ENTERITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>10 MG/ML - 5 ML FLASK</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOBREX</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>EYE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEPAFENAC</medicinalproduct>
        <drugdosagetext>1 TO 3 TIMES DAILY</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANADOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134906-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-10P-087-0675304-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTEBRAL ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100819</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100902</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIMETIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100902</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134907-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-10P-087-0681878-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>48</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NYSTAGMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALAZOSULFAPYRIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101014</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134908-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0685564-00</companynumb>
    <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>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>88025LJ42</drugbatchnumb>
        <drugdosagetext>160 MG LOADING DOSE</drugdosagetext>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>88025LJ42</drugbatchnumb>
        <drugdosagetext>80 MG LOADING DOSE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>88025LJ42</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
        <drugindication>COLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROSCYAMINE</medicinalproduct>
        <drugdosagetext>SUB LIQ</drugdosagetext>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VISTOLIC</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXFORGE</medicinalproduct>
        <drugdosagetext>5MG/320MG</drugdosagetext>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugindication>ULCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134909-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ABBOTT-10P-150-0681473-00</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREAS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>15 MG/WEEK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORUDIS</medicinalproduct>
        <drugdosagetext>200 MG TO THE NIGHT</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALVEDON</medicinalproduct>
        <drugdosagetext>1-2 TABL. WHEN NEEDED</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLACIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134910-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-AVENTIS-2010SA055529</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugbatchnumb>U</drugbatchnumb>
        <drugauthorizationnumb>020905</drugauthorizationnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134911-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13566BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>BRONCHITIS CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134912-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101109058</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>1</drugcharacterization>
        <medicinalproduct>SIMPONI</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134913-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20101001000</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SAPHO SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>3 INFUSIONS AT 3 MG/KG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>3 INFUSIONS AT 6 MG/KG  6 INFUSIONS TOTAL</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FASTIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugindication>SAPHO SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BASEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134914-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20100905220</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GOLIMUMAB</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONNECTIVE TISSUE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONNECTIVE TISSUE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GASMET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134915-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101001723</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>
      <patientweight>79</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMPONI</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND HCT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>6-7 DAYS PER WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134920-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DE-SANOFI-AVENTIS-2010SA072517</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020905</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134921-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20100906220</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>36</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>9CM31011;9AM15015P1 +MORE</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>9CM31011;9AM15015P1 +MORE</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>9CM31011;9AM15015P1 +MORE</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134923-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20100510146</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPO-MEDROL</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPO-MEDROL</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM W/VITAMIN D NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134924-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20101109030</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>
      <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADALIMUMAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134925-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20101109031</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>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>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134926-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101006862</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM DIFFICILE COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CULTURE URINE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURODEGENERATIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SARCOIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SARCOIDOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134927-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101004544</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134928-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-JNJFOC-20101108860</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134931-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-GENENTECH-307679</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>APPENDICITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENSION HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1000 MG, Q15D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100308</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TANDRILAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVAMOX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANTIBIOTIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLASIL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134932-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-JNJFOC-20101104306</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STERNAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETYL SALICYLIC ACID USP BAT</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETYL SALICYLIC ACID USP BAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134933-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20100908187</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.14</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE MALFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMPONI</medicinalproduct>
        <drugbatchnumb>LOT NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134934-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20100300885</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAL FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIRECTAL ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GROWTH HORMONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADAPALENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LETROZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPINEPHRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE  VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLORAJEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXANDROLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROBIOTICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134935-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20100703772</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION PSEUDOMONAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFLAMMATORY BOWEL DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NU-IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIBICLENS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOTRIMAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTAID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMYLASE LIPASE PROTEASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUXIQ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESALAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUPIROCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTROBAN</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONTELUKAST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIPLE VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA-3 FATTY ACIDS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROBIOTICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134937-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201010007083</companynumb>
    <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>WEIGHT BEARING DIFFICULTY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A719441C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134938-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101120</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011006252</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A709633C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENALIDOMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134939-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201010004626</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A723778C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
        <drugdosagetext>40 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIL SODIUM</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDICAL</medicinalproduct>
        <drugdosagetext>30 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugdosagetext>0.005 %, EACH EVENING</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOLOL</medicinalproduct>
        <drugdosagetext>UNK, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CITRATE WITH VITAMIN D</medicinalproduct>
        <drugdosagetext>UNK, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>UNK, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>UNK, EACH EVENING</drugdosagetext>
        <drugindication>GOUT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134940-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201010002309</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A638543C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101008</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>200 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>2.5 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QVAR 40</medicinalproduct>
        <drugdosagetext>2 D/F, 2/D</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>2 D/F, AS NEEDED</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>50000 U, WEEKLY (1/W)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134941-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101121</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011006259</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>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134942-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011006073</companynumb>
    <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>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134944-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011006117</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>INCOHERENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A719438D</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134945-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201010005486</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>40.816</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FRACTURED SACRUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>15 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL AND ACETAMINOPHEN</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULCOLAX</medicinalproduct>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>600 MG, EACH EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>40 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL                                 /SCH/</medicinalproduct>
        <drugdosagetext>1000 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
        <drugdosagetext>8.6 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugdosagetext>8 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugdosagetext>0.5 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM 500+D3</medicinalproduct>
        <drugdosagetext>500 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugdosagetext>UNK, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
        <drugdosagetext>10 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134946-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011006180</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>COLON CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>020815</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134947-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011006108</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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134948-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101120</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201008006030</companynumb>
    <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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FUSION SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>020815</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A713107C</drugbatchnumb>
        <drugdosagetext>20 UG, UNK</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>1 D/F, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOLTERODINE TARTRATE</medicinalproduct>
        <drugdosagetext>1 D/F, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA-S /01035001/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>2 D/F, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUMS</medicinalproduct>
        <drugdosagetext>2 D/F, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>1 D/F, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>1 D/F, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOTRIMAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN                                /SCH/</medicinalproduct>
        <drugdosagetext>UNK, 3/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 3</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE</medicinalproduct>
        <drugdosagetext>30 MG, AS NEEDED</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134949-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201010006806</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>AORTIC STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100911</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UROXATRAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134950-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101121</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011006260</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>VERTEBROPLASTY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100922</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134951-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006368</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>FACIAL NERVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPOROMANDIBULAR JOINT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1011870</drugbatchnumb>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134952-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2010-41959</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134953-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2010-41955</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>TRACLEER</medicinalproduct>
        <drugbatchnumb>EP071P0103</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CHANNEL BLOCKERS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134954-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2010-41990</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 125 MG US</medicinalproduct>
        <drugbatchnumb>EP071P0103</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 125 MG US</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100914</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CHANNEL BLOCKERS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134955-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2010-41996</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>EP072P0102</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134956-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2010-41960</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
        <drugbatchnumb>01510H</drugbatchnumb>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>10 UG,</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>EP0160101</drugbatchnumb>
        <drugdosagetext>125</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134957-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GENZYME-CAMP-1001160</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAMPATH</medicinalproduct>
        <drugdosagetext>3 MG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100531</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAMPATH</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAMPATH</medicinalproduct>
        <drugdosagetext>30 MG, TIW</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100820</drugenddate>
        <drugtreatmentduration>80</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134958-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GENZYME-THYM-1002128</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>APLASTIC ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100329</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134959-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ACTELION-A-CH2010-42035</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>ILEUS PARALYTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK , UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SKIN ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134960-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ACTELION-A-CH2010-41303</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOTRACHEAL INTUBATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 125 MG ROW</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SKIN ULCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 125 MG ROW</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTOXIFYLLINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134961-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ACTELION-A-CH2010-41512</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIGHT VENTRICULAR FAILURE</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134962-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006616</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STENT PLACEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1021299</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134963-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>EG-JNJFOC-20101101090</companynumb>
    <primarysource>
      <reportercountry>EGYPT</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PALIPERIDONE PALMITATE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PALIPERIDONE PALMITATE</medicinalproduct>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134965-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ALLERGAN-1015360US</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID PTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOXA?</medicinalproduct>
        <drugdosagetext>24 UNITS, SINGLE</drugdosagetext>
        <drugindication>SKIN WRINKLING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134966-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GENZYME-CLOF-1001335</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>CLOLAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021673</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134969-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GENZYME-CLOF-1001336</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>CLOLAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021673</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134970-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHNY2010GB00531</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>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL (NCH)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CODEINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134971-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHNY2010GB00536</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL (NCH)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPHENIDATE</medicinalproduct>
        <drugdosagetext>80 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELATONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMPHETAMINE SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134972-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHNY2010GB00530</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL (NCH)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CODEINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134973-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHNY2010GB00535</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL (NCH)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPHENIDATE</medicinalproduct>
        <drugdosagetext>290 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLU TABLETS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134974-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHNY2010GB00532</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL (NCH)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CODEINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIHYDROCODEINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134975-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHNY2010GB00537</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL (NCH)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPHENIDATE</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHANOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134976-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10061066</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>95.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134977-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2010-41992</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>EP072P0102</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CHANNEL BLOCKERS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134978-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-JNJFOC-20101200045</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>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF INJURIOUS BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugauthorizationnumb>015923</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134979-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-JNJFOC-20101200146</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREZISTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREZISTA</medicinalproduct>
        <drugauthorizationnumb>021976</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134980-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-JNJFOC-20100509782</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>180</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMPONI</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMPONI</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERSYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IKOREL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134981-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20101108749</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>AXILLARY VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERFORMANCE STATUS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHLEBITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHLEBITIS SUPERFICIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMINYL</medicinalproduct>
        <drugauthorizationnumb>021169</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEMANTINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABNORMAL BEHAVIOUR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABNORMAL BEHAVIOUR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPEGIC 1000</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFARCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134984-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ALLERGAN-1015374US</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>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOX COSMETIC</medicinalproduct>
        <drugdosagetext>4000 UNITS, SINGLE</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134985-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-GENENTECH-310114</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>MENINGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PULMOZYME</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CYSTIC FIBROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090521</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134986-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GENZYME-POMP-1001209</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>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYOZYME</medicinalproduct>
        <drugindication>GLYCOGEN STORAGE DISEASE TYPE II</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134987-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-10P-020-0679215-00</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>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APTYALISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EROSIVE DUODENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EROSIVE OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS EROSIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNODEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASTICATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSITIVITY OF TEETH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIITH NERVE PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MAGISTRAL FORMULA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugindication>GASTRIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBINED FORMULA: CICLOBENZAPRIN + DIACEREIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugdosagetext>1.5 EVERY 24 HOURS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134988-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-1011USA03471</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID RPD</medicinalproduct>
        <drugauthorizationnumb>020752</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134989-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0805AUS00098</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070820</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134990-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-1011FRA00105</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100910</drugenddate>
        <drugtreatmentduration>61</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JOSAMYCIN PROPIONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FOLLICULITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100913</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134991-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-MERCK-1003ESP00037</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>CERVICAL DYSPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE RUPTURE OF MEMBRANES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VICTIM OF SPOUSAL ABUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISENTRESS</medicinalproduct>
        <drugauthorizationnumb>022145</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081103</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISENTRESS</medicinalproduct>
        <drugauthorizationnumb>022145</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARUNAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARUNAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE AND ZIDOVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MATERNAL THERAPY TO ENHANCE FOETAL LUNG MATURITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100826</drugenddate>
        <drugtreatmentduration>48</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134992-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-MERCK-1011USA03110</companynumb>
    <primarysource>
      <reportercountry>CHINA</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>DECADRON</medicinalproduct>
        <drugauthorizationnumb>011664</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134993-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-MERCK-1003ESP00037B1</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL FOR DATES BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISENTRESS</medicinalproduct>
        <drugauthorizationnumb>022145</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARUNAVIR</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE AND ZIDOVUDINE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>MATERNAL THERAPY TO ENHANCE FOETAL LUNG MATURITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100826</drugenddate>
        <drugtreatmentduration>48</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134994-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0603AUS00234</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>METABOLIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040728</drugenddate>
        <drugtreatmentduration>1079</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METABOLIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040728</drugenddate>
        <drugtreatmentduration>1671</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </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>CANDESARTAN CILEXETIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFACLOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN AND CLAVULANATE POTASSIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134995-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0808USA05314</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>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE FORMATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID BRUIT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTED CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INNER EAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGAMENT SPRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LORDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENISCAL DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS MEDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATELLOFEMORAL PAIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIODONTAL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYMPANIC MEMBRANE PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE ENLARGEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICOSE VEIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS FLOATERS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19961021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010730</drugenddate>
        <drugtreatmentduration>1744</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080705</drugenddate>
        <drugtreatmentduration>2533</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134996-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0210AUS00115</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOGLOBINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROXITHROMYCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134997-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-1011USA03783</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>021445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134998-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-1011USA03553</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMEND</medicinalproduct>
        <drugauthorizationnumb>021549</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>HEAD AND NECK CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>HEAD AND NECK CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>HEAD AND NECK CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7134999-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-1009DEU00072</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>021445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135000-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0705USA02864</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>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANORECTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDIX DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONCUSSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPRISONMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL SELF-INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SPRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUNCHAUSEN'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHYSICAL ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE MENOPAUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL DETACHMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNAKE BITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRISMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>JAW FRACTURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135002-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0402AUS00148</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>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COMPLICATIONS OF TRANSPLANT SURGERY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROXITHROMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135003-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-1011USA03499</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOCERYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLOPRIM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135004-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0603AUS00230</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROXITHROMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COAGULOPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE ABNORMAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135005-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-1011USA03496</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>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugauthorizationnumb>019462</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN TRIHYDRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135006-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-1011USA03567</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</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>PROPECIA</medicinalproduct>
        <drugauthorizationnumb>020788</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANDROGENETIC ALOPECIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135007-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1009USA04142</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19780101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135008-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-1010FRA00004</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugauthorizationnumb>022044</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIVALPROEX SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMISULPRIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYAMEMAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE CAMSYLATE AND EUCALYPTOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYPROTERONE ACETATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SACCHAROMYCES BOULARDII</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100905</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100918</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIXOCORTOL PIVALATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100918</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLYETHYLENE GLYCOL 3350 AND POTASSIUM CHLORIDE AND SODIUM BICARBONATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100918</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN PAMOATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100919</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACEPROMETAZINE MALEATE AND MEPROBAMATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135009-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1003USA01838</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>95</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTINIC KERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLAVICLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EROSIVE OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CAVITY FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEODYSTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAROTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRISMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIITH NERVE PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19951115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020329</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090826</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19951115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020329</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090826</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135010-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0402AUS00165</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TROPONIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN AND CLAVULANATE POTASSIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135011-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0710AUS00152</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>128</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CELLULITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070311</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135012-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0805USA00741</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>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTIPHOSPHOLIPID ANTIBODIES POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORNEAL ABRASION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EDENTULOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EUSTACHIAN TUBE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LICHEN PLANUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL TORUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHLEBITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEASONAL ALLERGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SIALOADENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER-AIRWAY COUGH SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SENILE OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011001</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061201</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEART RATE IRREGULAR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19590101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135013-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-1004USA03752</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>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMEND</medicinalproduct>
        <drugauthorizationnumb>021549</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100331</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMEND</medicinalproduct>
        <drugauthorizationnumb>021549</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100402</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOUGHMAC E</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLATOSIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDENALIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NATRIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIZE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERLAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARZULENE-S</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIYA BM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID RPD</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAGAMET</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXART</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135014-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0603AUS00229</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PERTUSSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031212</drugenddate>
        <drugtreatmentduration>39</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLESTYRAMINE RESIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND CODEINE PHOSPHATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135015-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-1011FRA00122</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYP COLORECTAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOROXIN</medicinalproduct>
        <drugauthorizationnumb>019384</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101024</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACENOCOUMAROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101024</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ARGININE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135016-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-1005FRA00086</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100519</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135017-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1004USA03498</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>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BARRETT'S OESOPHAGUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER RECURRENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERUMEN IMPACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMORAL NECK FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCCULT BLOOD POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL TORUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS EXTERNA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SIALOADENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DEPOSIT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080201</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIVELLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071201</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORMONES (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135018-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-MERCK-1011ESP00031</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSON'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135019-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-1011USA03385</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>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135021-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0909FRA00038</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugauthorizationnumb>021762</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAFTAZONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135022-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0704USA05956</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>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADHESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTONIC BLADDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED TENDENCY TO BRUISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SPRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL HERPES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIODONTAL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYCYTHAEMIA VERA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULPITIS DENTAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEASONAL ALLERGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MODURETIC 5-50</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135023-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1008USA00343</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>FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPECIA</medicinalproduct>
        <drugauthorizationnumb>020788</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ALOPECIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROGAINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135024-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-10P-087-0681679-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101013</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135025-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-10P-062-0687839-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARATHYROIDECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEMPLAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020819</drugauthorizationnumb>
        <drugdosagetext>3 AMPOULE PER WEEK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPERPARATHYROIDISM SECONDARY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100409</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERRELECIT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIPHOSPHAT</medicinalproduct>
        <drugdosagetext>THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
        <drugdosagetext>ONCE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100303</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIMPARA</medicinalproduct>
        <drugdosagetext>ONCE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>ONCE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMID</medicinalproduct>
        <drugdosagetext>1.5 TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSUMAN BASAL</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSUMAN RAPID</medicinalproduct>
        <drugdosagetext>ON DEMAND</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>ONCE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080407</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTEOTRIOL</medicinalproduct>
        <drugdosagetext>THREE TIMES PER WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugdosagetext>TWO TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RETACRIT</medicinalproduct>
        <drugdosagetext>TWO PER WEEK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100303</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135026-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100827</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ALLERGAN-1011129US</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>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACZONE</medicinalproduct>
        <drugauthorizationnumb>021794</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135027-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100910</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ALLERGAN-1011725US</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>PAIN OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MORBILLIFORM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACZONE</medicinalproduct>
        <drugbatchnumb>3347</drugbatchnumb>
        <drugauthorizationnumb>021794</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100905</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135028-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ALLERGAN-1014694US</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>WOUND TREATMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACZONE</medicinalproduct>
        <drugbatchnumb>3947</drugbatchnumb>
        <drugauthorizationnumb>021794</drugauthorizationnumb>
        <drugdosagetext>1 DF, BID</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>WOUND</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135029-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101021</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ALLERGAN-1013550US</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>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAZORAC</medicinalproduct>
        <drugbatchnumb>66995</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101015</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACZONE</medicinalproduct>
        <drugbatchnumb>4112</drugbatchnumb>
        <drugauthorizationnumb>021794</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101015</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135030-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PERRIGO-10US014084</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>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT SUBSTITUTION ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOCONAZOLE</medicinalproduct>
        <drugbatchnumb>0C3431V</drugbatchnumb>
        <drugauthorizationnumb>075915</drugauthorizationnumb>
        <drugdosagetext>1 APPLICATOR, ONCE</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>VULVOVAGINAL MYCOTIC INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100828</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONTRACEPTIVES NOS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1 DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135032-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13490BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>EMPHYSEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
        <drugindication>EMPHYSEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugindication>EMPHYSEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135033-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13571BP</companynumb>
    <primarysource>
      <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>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135034-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13620BP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135035-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13377BP</companynumb>
    <primarysource>
      <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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIITH NERVE PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>001699</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>001699</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugindication>ATRIAL FLUTTER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135036-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13599BP</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</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>7135037-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-12767BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugbatchnumb>065572A</drugbatchnumb>
        <drugauthorizationnumb>020291</drugauthorizationnumb>
        <drugdosagetext>10 PUF</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135038-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-12184BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALATAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugbatchnumb>065568A,065557A</drugbatchnumb>
        <drugauthorizationnumb>020291</drugauthorizationnumb>
        <drugdosagetext>8 PUF</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100905</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>2000 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </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>JANUVIA</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM CD</medicinalproduct>
        <drugdosagetext>240 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTEK</medicinalproduct>
        <drugdosagetext>400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugdosagetext>150 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
        <drugdosagetext>12.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FLUID RETENTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugdosagetext>0.4 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROSTAT</medicinalproduct>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135039-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0034004</companynumb>
    <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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091218</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135040-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100818</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ALLERGAN-1010704US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACZONE</medicinalproduct>
        <drugauthorizationnumb>021794</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135041-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US79855</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101117</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135042-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010SE79238</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</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>PANIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>020823</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135043-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US64396</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL RESECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135044-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</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>ABSCESS DRAINAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIAL SECRETION RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK LEFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CENTRAL VENOUS CATHETERISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICAL CORD COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHONDROMALACIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED INTEREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL PULP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE MALFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM T WAVE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDODONTIC PROCEDURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPLANTABLE DEFIBRILLATOR INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KYPHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT ATRIAL DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LORDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUDWIG ANGINA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASTICATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENISCUS LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYASTHENIA GRAVIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIC SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSITIVITY OF TEETH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH REHABILITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FUSION ACQUIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBCUTANEOUS NODULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSURETHRAL PROSTATECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPEUTICS NOS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESSALON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARINEX                                /DEN/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIVERT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN AND CLAVULANATE POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORHEXIDINE GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APRESOLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN EXPECTORANT W/ CODEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCINEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135046-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2008US07606</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS DRAINAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA MACROCYTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOVENOUS FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BICARBONATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PARATHYROID HORMONE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PHOSPHORUS INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY DYSMORPHIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGAMMAGLOBULINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNOGLOBULINS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED GASTRIC EMPTYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC SPACE NARROWING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGAMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR SPINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN CELL HAEMOGLOBIN CONCENTRATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN CELL HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN CELL VOLUME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL BLISTERING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS MEDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIODONTAL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIODONTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHYSICAL DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLASMACYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRIMARY SEQUESTRUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICULAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY GLAND DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEQUESTRECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SIALOADENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL HAEMANGIOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL LAMINECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLOARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>ONCE MONTHLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RYTHMOL</medicinalproduct>
        <drugdosagetext>50 MG, 2QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugdosagetext>2 QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>2 QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INTERFERON</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEMODIALYSIS</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAMELOR</medicinalproduct>
        <drugindication>LIMB DISCOMFORT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENA-VITE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugdosagetext>8 MG,</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugdosagetext>5MG, Q8 PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
        <drugdosagetext>ONE TABLET, Q6 PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEPHRO-VITE</medicinalproduct>
        <drugindication>RENAL FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZEMPLAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
        <drugdosagetext>650 MG, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIDOXINE HCL</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR</medicinalproduct>
        <drugdosagetext>10 MEQ, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135048-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA80541</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TERMINAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>10 MG EVERY 04 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ACROMEGALY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000920</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135049-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US73827</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTAVIA</medicinalproduct>
        <drugdosagetext>0.25 MG, QOD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTAVIA</medicinalproduct>
        <drugdosagetext>0.3 MG, QOD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135050-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US44905</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135051-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010PL16569</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL MUCOSAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOUS MEMBRANE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALISKIREN ALI+TAB</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>150MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100928</drugenddate>
        <drugtreatmentduration>202</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100928</drugenddate>
        <drugtreatmentduration>187</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135052-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US14376</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPERATURE INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTAVIA</medicinalproduct>
        <drugdosagetext>0.25 MG, QOD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100306</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNITHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID</medicinalproduct>
        <drugdosagetext>25 UG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIVERT</medicinalproduct>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMANTADINE</medicinalproduct>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FATIGUE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIVERT ^PFIZER^</medicinalproduct>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135053-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP63267</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BETA-D-GLUCAN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLINESTERASE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNODEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION IN AN IMMUNOCOMPROMISED HOST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA CYTOMEGALOVIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROSEOLOVIRUS TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURFACTANT PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>50 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYSTAN</medicinalproduct>
        <drugdosagetext>5 MG ONCE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENIVACE</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BASEN</medicinalproduct>
        <drugdosagetext>0.4 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLAKAY</medicinalproduct>
        <drugdosagetext>45 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVACT</medicinalproduct>
        <drugdosagetext>12.45 G, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONILAC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER D</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135054-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US13872</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADRENAL MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPIRATION PLEURAL CAVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID BODY TUMOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYST DRAINAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYST RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOCRINE OPHTHALMOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA FACIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIFE EXPECTANCY SHORTENED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO CENTRAL NERVOUS SYSTEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO NASAL SINUSES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO SPINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO SPLEEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC CALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURODESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLOLISTHESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS NECROTISING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THORACOSTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOPHLEBITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOTAL LUNG CAPACITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE LEIOMYOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIITH NERVE PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEELCHAIR USER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050517</drugenddate>
        <drugtreatmentduration>1825</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FASLODEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCINEX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT                                 /UNK/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEN-VEE K</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>500MG - AM/ 300MG -PM</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABRAXANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AROMASIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAL ANTIDIABETICS</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135055-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010FR17770</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLIC ACID</medicinalproduct>
        <drugauthorizationnumb>050791</drugauthorizationnumb>
        <drugdosagetext>1440 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100819</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100819</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANITIDINE HCL</medicinalproduct>
        <drugdosagetext>150 MG</drugdosagetext>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROVALCYTE</medicinalproduct>
        <drugdosagetext>450 MG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
        <drugtreatmentduration>83</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugdosagetext>400 MG</drugdosagetext>
        <drugindication>ANTIFUNGAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
        <drugtreatmentduration>87</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135056-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US62966</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 CREATINE PHOSPHOKINASE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100825</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>125 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZID</medicinalproduct>
        <drugdosagetext>37.5-25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100525</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135057-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010FR14691</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CERTICAN</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135058-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-ABBOTT-10P-044-0687675-00</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYNEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135059-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TT-ABBOTT-10P-159-0682905-00</companynumb>
    <primarysource>
      <reportercountry>TRINIDAD AND TOBAGO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING OF BODY TEMPERATURE CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018723</drugauthorizationnumb>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018723</drugauthorizationnumb>
        <drugdosagetext>100 DOSAGE FORM TABLETS ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>OD</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135060-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ABBOTT-10P-013-0689164-00</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135061-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ABBOTT-10P-114-0687826-00</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>160MG ON 11-SEP-2010, 80MG ON 25-SEP-2010, 40 MG EVERY 2 WEEKS FROM 12-OCT-2010 ONWARDS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100911</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135062-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-14876726</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INTERCEPTED MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
        <drugauthorizationnumb>020155</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135063-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100406</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15051048</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VASCULAR INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
        <drugauthorizationnumb>020154</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135064-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100428</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15069123</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PORTAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
        <drugauthorizationnumb>020154</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19891201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135065-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15179831</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
        <drugauthorizationnumb>020154</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135066-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15181365</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
        <drugauthorizationnumb>020154</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135067-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15181373</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
        <drugauthorizationnumb>020154</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135068-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15181381</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
        <drugauthorizationnumb>020154</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135069-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15181399</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
        <drugauthorizationnumb>020154</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135070-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15181407</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
        <drugauthorizationnumb>020154</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135071-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100916</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15289705</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>BLOOD URIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
        <drugauthorizationnumb>020154</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135072-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15309727</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>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
        <drugauthorizationnumb>020154</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135073-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15311442</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>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
        <drugauthorizationnumb>020154</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135074-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0894269A</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC LYMPHOCYTIC LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA HEPATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS B</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATORENAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PORTAL VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARZERRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135075-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2010GB05479</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>GASTRIC BYPASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLIMAVAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135076-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100405</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0034006</companynumb>
    <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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100211</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135077-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-200993USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>105.33</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
        <drugindication>MUSCLE SPASMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080430</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYL SALICYLIC ACID USP BAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIBOMET</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINZIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>GOUT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135078-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-257876USA</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>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECONOMIC PROBLEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE INJURIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135079-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20100308147</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>WEEK 6</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>WEEK 2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>WEEK 0</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-CORTEF</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135080-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-257890USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135082-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201008001986</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL SELF-INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>021411</drugauthorizationnumb>
        <drugdosagetext>40 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>021411</drugauthorizationnumb>
        <drugdosagetext>80 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100303</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100303</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135083-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE201011005030</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100913</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </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>20100914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100919</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>1.5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100915</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>1 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100917</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>0.5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100919</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135084-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-ELI_LILLY_AND_COMPANY-DK201007006904</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIC MYOCARDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>15 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugdosagetext>30 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARINTAPIN</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135085-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ELI_LILLY_AND_COMPANY-IT201011005952</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>20 U, DAILY (1/D)</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>26 U, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REPAGLINIDE</medicinalproduct>
        <drugdosagetext>6 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>1.25 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>125 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
        <drugdosagetext>0.75 D/F, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMAZINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>8 D/F, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCERYL TRINITRATE</medicinalproduct>
        <drugdosagetext>20 D/F, UNK</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135086-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201006000672</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>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, 2/D</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135087-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011005707</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>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT OPERATION COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR HOLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>A734239A</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugdosagetext>14 UNK, 2/D</drugdosagetext>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugdosagetext>4 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>500 MG, 3/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>25 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>25 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>160 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MENTAX</medicinalproduct>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>UNK, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-Q10</medicinalproduct>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135088-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011005449</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>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugtreatmentduration>61</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135090-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HU-ELI_LILLY_AND_COMPANY-HU201011006111</companynumb>
    <primarysource>
      <reportercountry>HUNGARY</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>SKIN TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DULOXETINE HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101111</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135091-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011005730</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>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135092-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201001004269</companynumb>
    <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>SPINAL LAMINECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A551500C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMIDONE</medicinalproduct>
        <drugindication>TREMOR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANALGESICS</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135093-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ELI_LILLY_AND_COMPANY-GB201011005991</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>EXCORIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTROPHIC CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
        <drugindication>BIPOLAR I DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugdosagetext>500 MG, 2/D</drugdosagetext>
        <drugindication>BIPOLAR I DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135094-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ELI_LILLY_AND_COMPANY-GB201010002312</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>78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugauthorizationnumb>018936</drugauthorizationnumb>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100906</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100916</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135095-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SK-ELI_LILLY_AND_COMPANY-SK201010003058</companynumb>
    <primarysource>
      <reportercountry>SLOVAKIA (Slovak Republic)</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>0.5 MG, 3/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135096-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201009006056</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>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMATROPE</medicinalproduct>
        <drugbatchnumb>A620974J</drugbatchnumb>
        <drugauthorizationnumb>019640</drugauthorizationnumb>
        <drugdosagetext>0.25 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>BLOOD GROWTH HORMONE DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMATROPE</medicinalproduct>
        <drugbatchnumb>A620974J</drugbatchnumb>
        <drugauthorizationnumb>019640</drugauthorizationnumb>
        <drugdosagetext>0.2 MG, DAILY (1/D)</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135097-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HU-ELI_LILLY_AND_COMPANY-HU201010000418</companynumb>
    <primarysource>
      <reportercountry>HUNGARY</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>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100325</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135098-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200804000248</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>111</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE MALFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECONOMIC PROBLEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE INFECTION BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>A569856A</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>A734239A</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>1000 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>1000 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>10 U, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>40 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL</medicinalproduct>
        <drugdosagetext>40 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>25 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135099-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011005463</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>30 MG, 2/D</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135100-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-ELI_LILLY_AND_COMPANY-TR201011006388</companynumb>
    <primarysource>
      <reportercountry>TURKEY</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>BENIGN INTRACRANIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAPILLOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>15 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugdosagetext>1000 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugdosagetext>40 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135101-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201011005377</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>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>UNK, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>1 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GOODMIN</medicinalproduct>
        <drugdosagetext>0.25 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugdosagetext>1 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALTHROW</medicinalproduct>
        <drugdosagetext>0.2 MG, DAILY (1/D)</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135102-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR201011004822</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>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135103-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011005438</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>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUMERUS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FUSION SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILNACIPRAN</medicinalproduct>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTHROTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135104-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE201011005072</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>PHOTOSENSITIVITY ALLERGIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>30 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100514</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STANGYL</medicinalproduct>
        <drugdosagetext>12.5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100614</drugenddate>
        <drugtreatmentduration>54</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100515</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135105-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201009005440</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>20 MG, 3/D</drugdosagetext>
        <drugindication>NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>20 MG, 2/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>UNK, 3/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>40 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>20 MG, AS NEEDED</drugdosagetext>
        <drugindication>OEDEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugdosagetext>20 MG, EACH MORNING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugdosagetext>20 MG, EACH EVENING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STOOL SOFTENER</medicinalproduct>
        <drugdosagetext>UNK, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugdosagetext>5 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROVANA</medicinalproduct>
        <drugdosagetext>UNK, 2/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
        <drugdosagetext>50 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>10 MEQ, 2/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>0.25 MG, 4/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE</medicinalproduct>
        <drugdosagetext>35 MG, WEEKLY (1/W)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCINEX</medicinalproduct>
        <drugdosagetext>1200 MG, 2/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>1000 IU, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM 500+D3</medicinalproduct>
        <drugdosagetext>500 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135106-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200901003260</companynumb>
    <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 BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAIR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPIDS INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELANOCYTIC NAEVUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MORBID THOUGHTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEAU D'ORANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICHORRHEXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>7.5 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135107-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011005778</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>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>A735990A</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135108-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR201011006849</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>30 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135109-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201009005908</companynumb>
    <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>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100625</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORGARD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135110-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR201011005416</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>30 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>30 MG, QOD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135111-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011005978</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>81.633</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRA-ABDOMINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135112-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200803001331</companynumb>
    <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>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK SECOND DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC PACEMAKER REVISION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCOHERENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYPECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINOPEXY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN NEOPLASM EXCISION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>30 MG, 2/D</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugdosagetext>45 MG, EACH EVENING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugdosagetext>1 MG, 3/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>50 MG, 2/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
        <drugdosagetext>180 MG, 2/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>1 D/F, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE</medicinalproduct>
        <drugdosagetext>325 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugdosagetext>1 D/F, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugdosagetext>30 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>137 UG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>1000 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>400 MG, EACH EVENING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>10 MG, EACH EVENING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugdosagetext>0.4 MG, EACH EVENING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugdosagetext>10 MG, EACH EVENING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
        <drugdosagetext>100 MG, 2/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE/CHONDROITIN            /01625901/</medicinalproduct>
        <drugdosagetext>1 D/F, 3/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
        <drugdosagetext>2 D/F, AS NEEDED</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DYSPNOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVENTIL                               /USA/</medicinalproduct>
        <drugdosagetext>2 D/F, AS NEEDED</drugdosagetext>
        <drugindication>DYSPNOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASTELIN</medicinalproduct>
        <drugdosagetext>2 D/F, AS NEEDED</drugdosagetext>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugdosagetext>1 D/F, AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>1 D/F, AS NEEDED</drugdosagetext>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL                           /SCH/</medicinalproduct>
        <drugdosagetext>2 D/F, AS NEEDED</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>1 MG, 3/D</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAALOX</medicinalproduct>
        <drugdosagetext>2 D/F, AS NEEDED</drugdosagetext>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>50 MG, AS NEEDED</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135113-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-ELI_LILLY_AND_COMPANY-IE201011005255</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135114-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897457A</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>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR ICTERUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEATORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLI</medicinalproduct>
        <drugbatchnumb>12148</drugbatchnumb>
        <drugauthorizationnumb>021887</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WEIGHT LOSS DIET</drugindication>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135115-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101200995</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>
      <patientweight>18.14</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL DRUG INTAKE BY CHILD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID COMPLETE</medicinalproduct>
        <drugauthorizationnumb>020958</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID COMPLETE</medicinalproduct>
        <drugauthorizationnumb>020958</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACCIDENTAL EXPOSURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135116-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101108237</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MATERNAL DRUGS AFFECTING FOETUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE CONGENITAL ABNORMALITIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEMASOLE</medicinalproduct>
        <drugauthorizationnumb>017481</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRON SUPPLEMENTS</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135118-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101002065</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>45.36</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRIMACING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>020281</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135120-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2010127284</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101011</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135121-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010126371</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>PYODERMA GANGRENOSUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUNITINIB MALATE</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>37.5 MG, 1X/DAY</drugdosagetext>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100818</drugenddate>
        <drugtreatmentduration>560</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLANAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILECE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBAL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIRSTCIN</medicinalproduct>
        <drugdosagetext>1 G, 2X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100703</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFOPERAZONE SODIUM/SULBACTAM SODIUM</medicinalproduct>
        <drugdosagetext>1 G, 2X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100714</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAFAMOSTAT MESILATE</medicinalproduct>
        <drugdosagetext>20 MG, 2X/DAY</drugdosagetext>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100704</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135122-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010116566</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AROMASIN</medicinalproduct>
        <drugauthorizationnumb>020753</drugauthorizationnumb>
        <drugdosagetext>25 MG, 1X/DAY</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
        <drugtreatmentduration>131</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AROMASIN</medicinalproduct>
        <drugauthorizationnumb>020753</drugauthorizationnumb>
        <drugindication>MASTECTOMY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALTRATE 600 + VITAMIN D</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>1 MG, 3X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugdosagetext>20 MG, 3X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM SILVER</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UREX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135123-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033991</companynumb>
    <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>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101129</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135124-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-257929USA</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>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
        <drugindication>MUSCLE SPASMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060602</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135125-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GENENTECH-210499</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135128-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-KINGPHARMUSA00001-K201001447</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APPARENT DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS PRESSURE JUGULAR DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEPTRA</medicinalproduct>
        <drugauthorizationnumb>017376</drugauthorizationnumb>
        <drugdosagetext>1920 MG, QID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMOCYSTIS JIROVECI INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEPTRA</medicinalproduct>
        <drugauthorizationnumb>017376</drugauthorizationnumb>
        <drugdosagetext>960 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEPTRA</medicinalproduct>
        <drugauthorizationnumb>017376</drugauthorizationnumb>
        <drugdosagetext>3840 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMAQUINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PNEUMOCYSTIS JIROVECI INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMAQUINE</medicinalproduct>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135129-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-GENENTECH-310117</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>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PULMOZYME</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CYSTIC FIBROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070917</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135130-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GENENTECH-300735</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>B-LYMPHOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICROANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091005</drugenddate>
        <drugtreatmentduration>204</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>7.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZULFIDINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LODOTRA</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMIZOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135132-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-GENENTECH-310115</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>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PULMOZYME</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CYSTIC FIBROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081104</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135133-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GENENTECH-307305</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEPTIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOCISTEINE</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>DILTIAZEM</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>CO-AMILOFRUSE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135134-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13573BP</companynumb>
    <primarysource>
      <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>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135135-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13619BP</companynumb>
    <primarysource>
      <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>20101202</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135136-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC.-2010-RO-01568RO</companynumb>
    <primarysource></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>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS PARALYTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRONGYLOIDIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugauthorizationnumb>084610</drugauthorizationnumb>
        <drugindication>LUNG SQUAMOUS CELL CARCINOMA STAGE IV</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugauthorizationnumb>084610</drugauthorizationnumb>
        <drugindication>EVIDENCE BASED TREATMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM + SULFAMETHOXAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135137-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13615BP</companynumb>
    <primarysource>
      <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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EMPHYSEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135138-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13617BP</companynumb>
    <primarysource>
      <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>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101202</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135139-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13623BP</companynumb>
    <primarysource>
      <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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101202</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135140-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GENENTECH-305820</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ENDOPHTHALMITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL DETACHMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135143-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010157015</companynumb>
    <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 SCREEN FALSE POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugauthorizationnumb>008762</drugauthorizationnumb>
        <drugdosagetext>100 MG FIVE PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135144-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010157032</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>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugauthorizationnumb>012541</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135145-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010162194</companynumb>
    <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>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATIC OPERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135146-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161791</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>20080527</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135147-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161155</companynumb>
    <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>NORVASC</medicinalproduct>
        <drugauthorizationnumb>019787</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCARDIA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135149-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2009249525</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>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>011839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>011839</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19981106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>0.625 MG, UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19981106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>0.625/2.5MG</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000815</drugenddate>
        <drugtreatmentduration>648</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTROGENS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHROID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000110</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135150-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010114192</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>50 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135151-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161977</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>TUBULOINTERSTITIAL NEPHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOSYN</medicinalproduct>
        <drugauthorizationnumb>050684</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135152-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010154795</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>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>50 MG, 2X/DAY</drugdosagetext>
        <drugindication>HEADACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135153-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010034328</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>DOXYCYCLINE HYCLATE</medicinalproduct>
        <drugauthorizationnumb>050007</drugauthorizationnumb>
        <drugindication>RASH</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135154-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160897</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82.993</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
        <drugauthorizationnumb>021228</drugauthorizationnumb>
        <drugdosagetext>4 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLADDER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135155-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010162920</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>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>0.3 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>0.3 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTROGENS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AYGESTIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135156-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010157117</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>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>50 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>50 MG, 4X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE</medicinalproduct>
        <drugdosagetext>20 MG, 2X/DAY</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugindication>BLOOD PRESSURE ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135157-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010156398</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>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REACTION TO DRUG EXCIPIENTS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRING</medicinalproduct>
        <drugauthorizationnumb>020472</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>VULVOVAGINAL DRYNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135158-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010148369</companynumb>
    <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>ADVIL</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135159-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-US-WYE-H17787610</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>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugbatchnumb>E00052</drugbatchnumb>
        <drugauthorizationnumb>020402</drugauthorizationnumb>
        <drugdosagetext>1 DF, EVERY 4 HRS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100927</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135160-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161965</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>TUBULOINTERSTITIAL NEPHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOSYN</medicinalproduct>
        <drugauthorizationnumb>050684</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135161-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010118767</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>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5 MG</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090515</drugenddate>
        <drugtreatmentduration>332</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135162-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161464</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>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN-125</medicinalproduct>
        <drugauthorizationnumb>008762</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135163-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161769</companynumb>
    <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>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135164-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010157039</companynumb>
    <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>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugdosagetext>3600 MG/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135165-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010147479</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>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>40 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNITHROID</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>81 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARMODAFINIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135166-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010159487</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>020151</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135167-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161838</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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080408</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135168-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010159451</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135169-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161181</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135170-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010155350</companynumb>
    <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>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135171-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160901</companynumb>
    <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>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>004782</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>OESTROGEN REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135172-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010157351</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.492</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugdosagetext>25 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135173-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010149352</companynumb>
    <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>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugbatchnumb>6339-013-21</drugbatchnumb>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>50 MG, 4X/DAY</drugdosagetext>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 3X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGESTERONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135174-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-HQWYE297616AUG04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>004782</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19810101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OGEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AYGESTIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>THYROID DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135175-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010162020</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>TUBULOINTERSTITIAL NEPHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOSYN</medicinalproduct>
        <drugauthorizationnumb>050684</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135176-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160620</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>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135177-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010128701</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugbatchnumb>0071-0805-24</drugbatchnumb>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>COMPLEX REGIONAL PAIN SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135178-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007048888</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND</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>20060726</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135179-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010157052</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 2X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135180-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160558</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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135181-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010157054</companynumb>
    <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>1</drugcharacterization>
        <medicinalproduct>AROMASIN</medicinalproduct>
        <drugauthorizationnumb>020753</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135182-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161414</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>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOVIAZ</medicinalproduct>
        <drugbatchnumb>7768656</drugbatchnumb>
        <drugauthorizationnumb>022030</drugauthorizationnumb>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLLAKIURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101122</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135183-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160574</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>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135184-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010155119</companynumb>
    <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 ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY SLEEP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>020151</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135185-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010129996</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>81.179</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>50 MG, 3X/DAY</drugdosagetext>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101010</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <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>NECK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135186-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010156980</companynumb>
    <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>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135187-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2009250501</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>210</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>011839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135188-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010162175</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>126.53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</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>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>UNK, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPICONDYLITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135189-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010154893</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>1200 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>0.5 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135190-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161962</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>TUBULOINTERSTITIAL NEPHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOSYN</medicinalproduct>
        <drugauthorizationnumb>050684</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135191-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010032235</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>72</patientweight>
      <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>UNK</drugdosagetext>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135192-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161960</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>TUBULOINTERSTITIAL NEPHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOSYN</medicinalproduct>
        <drugauthorizationnumb>050684</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135193-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160412</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>VIAGRA</medicinalproduct>
        <drugbatchnumb>0742001</drugbatchnumb>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135194-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-HQWYE804203FEB04</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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOMICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>020151</drugauthorizationnumb>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SOCIAL PHOBIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>020151</drugauthorizationnumb>
        <drugdosagetext>TITRATED UPT TO 300 MG DAILY OVER THE COURSE OF THREE WEEKS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugindication>SOCIAL PHOBIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000306</drugstartdate>
        <drugtreatmentduration>244</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
        <drugtreatmentduration>122</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135195-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-US-WYE-H18041310</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>GENITAL RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND SECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugbatchnumb>E25142</drugbatchnumb>
        <drugauthorizationnumb>020216</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>VULVOVAGINAL DRYNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100917</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135196-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160987</companynumb>
    <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>ESTRING</medicinalproduct>
        <drugauthorizationnumb>020472</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135197-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160570</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>HYPOAESTHESIA FACIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135198-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160989</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AROMASIN</medicinalproduct>
        <drugauthorizationnumb>020753</drugauthorizationnumb>
        <drugdosagetext>25 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>500 MG, 2X/DAY</drugdosagetext>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>600 MG, 2X/DAY</drugdosagetext>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135199-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-BAXTER-2010BH026367</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135200-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010156673</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>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BORATE/HYDROXYPROPYL GUAR/POLYETHYLENE GLYCOL/PROPYLENE GLYCOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135201-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160617</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>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135202-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010152575</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>43.991</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135203-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010162173</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>OROPHARYNGEAL BLISTERING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101125</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135204-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161445</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN-125</medicinalproduct>
        <drugauthorizationnumb>008762</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135205-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160091</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.39</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>TOVIAZ</medicinalproduct>
        <drugauthorizationnumb>022030</drugauthorizationnumb>
        <drugdosagetext>4 MG, 1X/DAY</drugdosagetext>
        <drugindication>URINARY INCONTINENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>10 MEQ, ALTERNATE DAY</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135206-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161760</companynumb>
    <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>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135207-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-US-WYE-H18504310</companynumb>
    <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>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135208-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010159465</companynumb>
    <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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135209-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161774</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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135210-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161286</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135211-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010159558</companynumb>
    <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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugauthorizationnumb>020151</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugauthorizationnumb>020151</drugauthorizationnumb>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135212-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160827</companynumb>
    <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>7135213-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010156213</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYPHRENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>37.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101122</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135214-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160757</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>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135215-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010148129</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>84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL CONGESTION RELIEF</medicinalproduct>
        <drugbatchnumb>E80796</drugbatchnumb>
        <drugauthorizationnumb>022565</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUS HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101105</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL CONGESTION RELIEF</medicinalproduct>
        <drugauthorizationnumb>022565</drugauthorizationnumb>
        <drugindication>NASAL CONGESTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135216-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010023412</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>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>25 MG, 6 WKS ON 2 WKS OFF</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135217-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160625</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>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135218-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010157310</companynumb>
    <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 RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOVIAZ</medicinalproduct>
        <drugauthorizationnumb>022030</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135219-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160836</companynumb>
    <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>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</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>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135220-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010148372</companynumb>
    <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>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135221-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-HQWYE245024SEP04</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>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135222-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160622</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>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOMICIDAL IDEATION</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>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135223-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-US-WYE-H18009610</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>133.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>225 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135224-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010156586</companynumb>
    <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 PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELIDS PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135225-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010154307</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>45.359</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugbatchnumb>100166AN</drugbatchnumb>
        <drugauthorizationnumb>020987</drugauthorizationnumb>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101111</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135226-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-US-WYE-H18524610</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>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugbatchnumb>E32934</drugbatchnumb>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>TWO TO THREE TABLETS THREE TIMES A DAY WITHOUT PHYSICIAN'S RECOMMENDATION</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135227-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2010-41966</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>TRACLEER</medicinalproduct>
        <drugbatchnumb>BP084P0101</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080110</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135228-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-BAXTER-2010BH028643</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</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>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135229-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0653778A</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>QUALITY OF LIFE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENSION HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>60MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUVOX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PANIC REACTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135230-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0680616A</companynumb>
    <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>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART DISEASE CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135231-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693029A</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>
      <patientweight>125.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGESTIVE CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135232-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0698887A</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>118.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IN-STENT ARTERIAL RESTENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACARDIAC THROMBUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</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>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135233-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0698894A</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>136.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060222</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135234-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0731199A</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>
      <patientweight>94.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040327</drugenddate>
        <drugtreatmentduration>70</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040928</drugenddate>
        <drugtreatmentduration>97</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIABETA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135235-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0743838A</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>93.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC CARDIOMYOPATHY</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>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135236-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0760949A</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>100</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135237-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0765771A</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>
      <patientweight>110.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROBINUL FORTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENTYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAMELOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERELAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENTYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOMOTIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135238-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0765786A</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>
      <patientweight>97.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEBULIZER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135239-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0765934A</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>
      <patientweight>81.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED ACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDARYL</medicinalproduct>
        <drugauthorizationnumb>021700</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135240-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0765937A</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>81.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050326</drugenddate>
        <drugtreatmentduration>145</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040728</drugenddate>
        <drugtreatmentduration>188</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135241-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0767204A</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>90.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</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>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135242-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0768736A</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135243-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0770504A</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>118.2</patientweight>
      <patientsex>2</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135244-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0772356A</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>100</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STARLIX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIABETA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81MG PER DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135245-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0774239A</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>
      <patientweight>99.1</patientweight>
      <patientsex>1</patientsex>
      <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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135246-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0774946A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE 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>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135247-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0775654A</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>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC STROKE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135248-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0779979A</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>
      <patientweight>79.5</patientweight>
      <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>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135249-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0780869A</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOPULMONARY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGESTIVE CARDIOMYOPATHY</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135250-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0786521A</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>ARRHYTHMIA</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>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050214</drugenddate>
        <drugtreatmentduration>294</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135251-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0789569A</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>
      <patientweight>87.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135252-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0793607A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <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>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060414</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135253-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0793832A</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>
      <patientweight>104.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135254-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0797795A</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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135255-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0800710A</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>AKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEG AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135256-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0814594A</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>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135257-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0832746A</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135258-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0832748A</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>86.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071229</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTAMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135259-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0832749A</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>154.5</patientweight>
      <patientsex>1</patientsex>
      <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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOCARBAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MERIDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135260-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0832750A</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>
      <patientweight>67.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDARYL</medicinalproduct>
        <drugauthorizationnumb>021700</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135261-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0851998A</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>
      <patientweight>165.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK FIRST DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</drugenddate>
        <drugtreatmentduration>52</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135262-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0857140A</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>
      <patientweight>145</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC FOOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROMECHANICAL DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERIAL PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION STAPHYLOCOCCAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080926</drugenddate>
        <drugtreatmentduration>757</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135263-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0861496B</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAZOPANIB</medicinalproduct>
        <drugauthorizationnumb>022465</drugauthorizationnumb>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100714</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>10MGK TWO TIMES PER WEEK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISPHOSPHONATES (NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135264-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0873462A</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROMACTA</medicinalproduct>
        <drugauthorizationnumb>022291</drugauthorizationnumb>
        <drugdosagetext>1CAP PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100802</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DANAZOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135265-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0874233A</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>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugbatchnumb>9ZP3435</drugbatchnumb>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135266-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101128</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0876615A</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER MALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GYNAECOMASTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LYMPH NODES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIPPLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIPPLE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOCTURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICAL MASTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSURETHRAL PROSTATECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE FLOW DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugauthorizationnumb>021319</drugauthorizationnumb>
        <drugdosagetext>.5MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100607</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMSULOSIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135267-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0881296A</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>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FURUNCLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugbatchnumb>0ZP1090</drugbatchnumb>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100902</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIGH BLOOD PRESSURE PILL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WATER PILL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135268-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0885078A</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>83.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</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>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135269-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0886147A</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>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN,2M06F2,1N04FY</drugbatchnumb>
        <drugauthorizationnumb>020444</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030522</drugenddate>
        <drugtreatmentduration>141</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
        <drugauthorizationnumb>020444</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135271-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0890412A</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>80.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020103</drugauthorizationnumb>
        <drugdosagetext>4MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101030</drugenddate>
        <drugtreatmentduration>51</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135272-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0891236A</companynumb>
    <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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOTRIENT</medicinalproduct>
        <drugbatchnumb>0173-0804-09</drugbatchnumb>
        <drugauthorizationnumb>022465</drugauthorizationnumb>
        <drugdosagetext>800MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101109</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135273-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0891800A</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>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
        <drugauthorizationnumb>020405</drugauthorizationnumb>
        <drugdosagetext>.125MG UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135274-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101128</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0893015A</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>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPARENT DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED INTEREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080511</drugenddate>
        <drugtreatmentduration>497</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCURRENT MEDICATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135275-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0894523A</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>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugbatchnumb>0ZP1867</drugbatchnumb>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVENTIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135276-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0895006A</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>118.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRALEX</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>30MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugdosagetext>200MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>2000MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVO GLYBURIDE</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugdosagetext>8MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFUZOSIN</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>1200MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APO FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA 3-6-9</medicinalproduct>
        <drugdosagetext>1CAP PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GOLD SPECTRUM</medicinalproduct>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
        <drugdosagetext>.625MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135277-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0896405A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MENINGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135278-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0896707A</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>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugdosagetext>1BLS TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEBULIZER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135279-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0896716A</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOTRIENT</medicinalproduct>
        <drugbatchnumb>0ZP5376</drugbatchnumb>
        <drugauthorizationnumb>022465</drugauthorizationnumb>
        <drugdosagetext>800MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100413</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135280-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0896717A</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYKERB</medicinalproduct>
        <drugbatchnumb>0ZP2516</drugbatchnumb>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugdosagetext>750MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135281-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0896719A</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>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYKERB</medicinalproduct>
        <drugbatchnumb>0ZP8006</drugbatchnumb>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugdosagetext>1250MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPY</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135282-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0896731A</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>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021319</drugauthorizationnumb>
        <drugdosagetext>.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135283-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0896735A</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugbatchnumb>0ZP9803</drugbatchnumb>
        <drugauthorizationnumb>021254</drugauthorizationnumb>
        <drugdosagetext>1PUFF PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
        <drugtreatmentduration>517</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135284-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897220A</companynumb>
    <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>SORIATANE</medicinalproduct>
        <drugauthorizationnumb>019821</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135285-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897341A</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135286-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897390A</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>PROMACTA</medicinalproduct>
        <drugauthorizationnumb>022291</drugauthorizationnumb>
        <drugindication>MYELOPROLIFERATIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135287-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897398A</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugbatchnumb>R448828</drugbatchnumb>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AEROLIN</medicinalproduct>
        <drugdosagetext>2PUFF TWICE PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101107</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135288-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897399A</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135289-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897405A</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROMECHANICAL DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIC-ISCHAEMIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONIC EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STATUS ASTHMATICUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135290-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897497A</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>152.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135291-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897501A</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>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROMACTA</medicinalproduct>
        <drugauthorizationnumb>022291</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROMIPLOSTIM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135292-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897516A</companynumb>
    <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>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135293-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897518A</companynumb>
    <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>WELLBUTRIN SR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020358</drugauthorizationnumb>
        <drugdosagetext>150MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100719</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135294-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897523A</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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</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>20061206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070607</drugenddate>
        <drugtreatmentduration>184</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135295-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897525A</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>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135296-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0564275A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugdosagetext>1000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASTUZUMAB</medicinalproduct>
        <drugdosagetext>6MGK EVERY 3 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL</medicinalproduct>
        <drugdosagetext>200MCG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081010</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135297-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0604007A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RELENZA</medicinalproduct>
        <drugauthorizationnumb>021036</drugauthorizationnumb>
        <drugdosagetext>10MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>INFLUENZA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091019</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135298-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0661242A</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHTHOUS STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DIASTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CENTRAL NERVOUS SYSTEM LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOSPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HISTIOCYTOSIS HAEMATOPHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCOHERENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVEDO RETICULARIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENIC LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALACICLOVIR</medicinalproduct>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STOMATITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACICLOVIR</medicinalproduct>
        <drugauthorizationnumb>020089</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ENCEPHALITIS HERPES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MANNITOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135299-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0661458A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>42</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</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>20100513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100517</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMETEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLIVAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPARA-CA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMITT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLATIBIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BESACOLIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECOBALAMIN</medicinalproduct>
        <drugdosagetext>1500MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENAZOL</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALONAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100513</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135300-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0665749A</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 CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARRANON</medicinalproduct>
        <drugauthorizationnumb>021877</drugauthorizationnumb>
        <drugdosagetext>2000MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100602</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135301-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0676714A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090823</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090914</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091029</drugenddate>
        <drugtreatmentduration>45</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091125</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091209</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100120</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100203</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100224</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100328</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100405</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100426</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100524</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100613</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100627</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100712</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100924</drugenddate>
        <drugtreatmentduration>74</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>1400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100924</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101006</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>225MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101126</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100929</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMIDONE</medicinalproduct>
        <drugdosagetext>125MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDANTOL</medicinalproduct>
        <drugdosagetext>210MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELOOP</medicinalproduct>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135302-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0676775A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SILENT MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060406</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060406</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERSYL</medicinalproduct>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>1000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135303-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0677251A</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>
      <patientweight>47</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRA-UTERINE DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugauthorizationnumb>018603</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091224</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HISTIOCYTOSIS HAEMATOPHAGIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091205</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUNE GLOBULIN INTRAVENOUS (HUMAN)</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HISTIOCYTOSIS HAEMATOPHAGIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091209</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>220MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HISTIOCYTOSIS HAEMATOPHAGIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HISTIOCYTOSIS HAEMATOPHAGIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100425</drugenddate>
        <drugtreatmentduration>140</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>16MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HISTIOCYTOSIS HAEMATOPHAGIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100131</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIVELESTAT SODIUM HYDRATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HISTIOCYTOSIS HAEMATOPHAGIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091210</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFEPIME</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HISTIOCYTOSIS HAEMATOPHAGIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091204</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN HCL</medicinalproduct>
        <drugdosagetext>500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CLOSTRIDIUM DIFFICILE COLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091204</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135304-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0681201A</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>BLOOD AMYLASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPOATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugauthorizationnumb>020564</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugauthorizationnumb>019655</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
        <drugauthorizationnumb>020977</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100909</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugdosagetext>80MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100909</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135305-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0684126A</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PROLACTIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMISULPRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100904</drugenddate>
        <drugtreatmentduration>3652</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135306-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0685225A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>CYSTITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYKERB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugdosagetext>750MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101117</drugenddate>
        <drugtreatmentduration>64</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>1800MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101117</drugenddate>
        <drugtreatmentduration>64</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135307-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0685305A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugauthorizationnumb>021254</drugauthorizationnumb>
        <drugdosagetext>2PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135308-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0685512A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100721</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100721</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIATEC</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100721</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVATREX</medicinalproduct>
        <drugdosagetext>2.5MG FOUR TIMES PER WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100721</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIFLOX</medicinalproduct>
        <drugdosagetext>500MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100721</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100721</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARDYFERON</medicinalproduct>
        <drugdosagetext>1UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100721</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEDERFOLINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100721</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINE B12</medicinalproduct>
        <drugdosagetext>1UNIT WEEKLY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100721</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135309-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0685816A</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020983</drugauthorizationnumb>
        <drugdosagetext>100MCG SIX TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
        <drugdosagetext>200MCG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135310-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0686096A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIMBEX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101029</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SKENAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101031</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPRIVAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101029</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIPARINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1G FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101031</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALFENTANIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101031</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFUROXIME</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050558</drugauthorizationnumb>
        <drugdosagetext>1500MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101029</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOCTRAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135311-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0686181A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK COMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYKERB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AROMASIN</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ADJUVANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACALCITOL</medicinalproduct>
        <drugdosagetext>35MG PER DAY</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135312-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0686227A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLEEPING TABLETS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135313-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0686255A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDUCT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020857</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIAPRIDAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERCIAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135314-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0686396A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>PLEURISY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
        <drugauthorizationnumb>020444</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135315-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0686718A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAINFUL RESPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALATAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugdosagetext>1G SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101114</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASAL PACKING</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135316-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0686833A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>ANOSMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVAMYS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>NASAL POLYPS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135317-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0686877A</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>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN ONSET OF SLEEP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugauthorizationnumb>020658</drugauthorizationnumb>
        <drugdosagetext>1MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135318-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687126A</companynumb>
    <primarysource>
      <reportercountry>LATVIA</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVE BIRTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIAGEN</medicinalproduct>
        <drugauthorizationnumb>020977</drugauthorizationnumb>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091022</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091012</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100125</drugenddate>
        <drugtreatmentduration>127</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INVIRASE</medicinalproduct>
        <drugdosagetext>2000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091012</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091012</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZERIT</medicinalproduct>
        <drugdosagetext>80MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100125</drugenddate>
        <drugtreatmentduration>96</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135319-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687126B</companynumb>
    <primarysource>
      <reportercountry>LATVIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDROTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIAGEN</medicinalproduct>
        <drugauthorizationnumb>020977</drugauthorizationnumb>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091022</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091012</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100125</drugenddate>
        <drugtreatmentduration>127</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INVIRASE</medicinalproduct>
        <drugdosagetext>2000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091012</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091012</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZERIT</medicinalproduct>
        <drugdosagetext>80MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100125</drugenddate>
        <drugtreatmentduration>96</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135320-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687151A</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD AMYLASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATORENAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPTODIN</medicinalproduct>
        <drugauthorizationnumb>021003</drugauthorizationnumb>
        <drugdosagetext>.1G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC CIRRHOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101117</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN K1</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHINESE MEDICINE</medicinalproduct>
        <drugindication>JAUNDICE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANSMETIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPARTIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135321-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687304A</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYVERB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugdosagetext>1000MG PER DAY</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135322-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687306A</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DELUSIONAL DISORDER, UNSPECIFIED TYPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugauthorizationnumb>022008</drugauthorizationnumb>
        <drugdosagetext>24MG PER DAY</drugdosagetext>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVODOPA</medicinalproduct>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135323-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687339A</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILATREND</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>50MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135324-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687341A</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>CONTINUOUS HAEMODIAFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACICLOVIR</medicinalproduct>
        <drugauthorizationnumb>018603</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MENINGOENCEPHALITIS HERPETIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100802</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLAMOXYL</medicinalproduct>
        <drugauthorizationnumb>050542</drugauthorizationnumb>
        <drugdosagetext>2G FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100722</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GADOLINIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SCAN WITH CONTRAST</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100722</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVETIRACETAM</medicinalproduct>
        <drugdosagetext>1500MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100729</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVALGIN</medicinalproduct>
        <drugdosagetext>500MG FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100722</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugdosagetext>350MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100722</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugdosagetext>2G TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100722</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMIZOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DALTEPARIN SODIUM</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>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D3</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135325-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687350A</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>74</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALVEOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugdosagetext>1250MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100616</drugenddate>
        <drugtreatmentduration>154</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugdosagetext>1800MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100616</drugenddate>
        <drugtreatmentduration>154</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN ASPART</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN DETEMIR</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100123</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135326-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687357A</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugauthorizationnumb>022008</drugauthorizationnumb>
        <drugdosagetext>24MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PARKINSONISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANDROCUR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135327-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>D0068520A</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTATIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PENILE OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugauthorizationnumb>020658</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100501</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MADOPAR</medicinalproduct>
        <drugdosagetext>62.5MG FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135328-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>D0069495A</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOTRIENT</medicinalproduct>
        <drugauthorizationnumb>022465</drugauthorizationnumb>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101108</drugenddate>
        <drugtreatmentduration>40</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMIZOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135329-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>Z0003261B</companynumb>
    <primarysource>
      <reportercountry>RUSSIAN FEDERATION</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</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>20100202</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>20100202</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135330-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2010-42080</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
        <drugbatchnumb>01511H</drugbatchnumb>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100707</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135331-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJCH-2010027354</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>36.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENADRYL ALLERGY CHEWABLE TABLET</medicinalproduct>
        <drugbatchnumb>ALC111</drugbatchnumb>
        <drugauthorizationnumb>005845</drugauthorizationnumb>
        <drugdosagetext>TEXT:TWICE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RASH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135332-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-256933USA</companynumb>
    <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>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING PROJECTILE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>070146</drugauthorizationnumb>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100706</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135333-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENZYME-CLOF-1001237</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC LYMPHOCYTIC LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOLAR</medicinalproduct>
        <drugbatchnumb>M07P056S1</drugbatchnumb>
        <drugauthorizationnumb>021673</drugauthorizationnumb>
        <drugdosagetext>30 MG/M2 (72MG), QDX5</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080608</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUSULFAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>3.2 MG/KG (307MG), QDX4</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080608</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTIGALL</medicinalproduct>
        <drugdosagetext>300 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR SODIUM</medicinalproduct>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN W</medicinalproduct>
        <drugdosagetext>875 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugdosagetext>250/50, 1 PUFF</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>2 PUFFS, Q4-6H</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugdosagetext>25 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION</medicinalproduct>
        <drugdosagetext>150 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext>500 MG, TID</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBETASOL</medicinalproduct>
        <drugdosagetext>0.05 %, BID</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTASIS</medicinalproduct>
        <drugdosagetext>1 DROP, BID</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>20 U, QHS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>24 U, QHS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugdosagetext>500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
        <drugdosagetext>2 G, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugdosagetext>32 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugdosagetext>48 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPRON</medicinalproduct>
        <drugdosagetext>1.5 G, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
        <drugdosagetext>5 ML, QID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>5 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugdosagetext>1 MG, Q12HR</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135334-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-BAXTER-2010BH028695</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</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>CHEMICAL PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>S10H16098</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>S10H24050</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101016</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135335-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010157958</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</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>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugauthorizationnumb>021267</drugauthorizationnumb>
        <drugdosagetext>200 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>FUNGAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101125</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugauthorizationnumb>021267</drugauthorizationnumb>
        <drugindication>SYSTEMIC MYCOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAXIZON</medicinalproduct>
        <drugdosagetext>500 MG/DAY, FREQUENCY UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAXIZON</medicinalproduct>
        <drugdosagetext>500 MG/DAY, FREQUENCY UNCPECIFIED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101127</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLITA T</medicinalproduct>
        <drugdosagetext>500 ML, FREQUENCY UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101124</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER</medicinalproduct>
        <drugdosagetext>(20) 1A, UNITS, FREQUENCY UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101124</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMEDIN INTRAVENOUS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101124</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101124</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
        <drugdosagetext>(0.5) IV 3X</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101123</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEFERASIROX</medicinalproduct>
        <drugdosagetext>1000 MG, 1X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBISOME</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101117</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135336-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010136963</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>53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</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>20091211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091224</drugenddate>
        <drugtreatmentduration>14</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>20100122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100204</drugenddate>
        <drugtreatmentduration>14</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>20100205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100214</drugenddate>
        <drugtreatmentduration>10</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>20100215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIGLITOL</medicinalproduct>
        <drugdosagetext>50 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NATEGLINIDE</medicinalproduct>
        <drugdosagetext>90 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS CITRATE</medicinalproduct>
        <drugdosagetext>50 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON DEFICIENCY ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugdosagetext>0.5 G, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091104</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135337-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010156243</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>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCOAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMSIROLIMUS</medicinalproduct>
        <drugauthorizationnumb>022088</drugauthorizationnumb>
        <drugdosagetext>25 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135340-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006769</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050702</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135341-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-BAXTER-2010BH029028</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>FUNGAL PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135342-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2010-42045</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>TRACLEER</medicinalproduct>
        <drugbatchnumb>EP072P0102</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CHANNEL BLOCKERS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135343-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-BAXTER-2010BH029098</companynumb>
    <primarysource>
      <reportercountry>INDIA</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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>1009028</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135346-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-BAXTER-2010BH029113</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>PERITONEAL DIALYSIS COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135347-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MPIJNJ-2010-03454</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>124.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugauthorizationnumb>021602</drugauthorizationnumb>
        <drugdosagetext>1.3 MG/M2, CYCLIC</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100702</drugenddate>
        <drugtreatmentduration>47</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLAVOPIRIDOL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>75 MG/M2, CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100702</drugenddate>
        <drugtreatmentduration>47</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135348-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0688073-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</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>7135349-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0688515-00</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>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXOPLASMOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugindication>BLOOD TRIGLYCERIDES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN EYE DROPS</medicinalproduct>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN EYE DROPS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135350-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-10P-087-0667096-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>51</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADRENAL INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS INFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYASTHENIA GRAVIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100305</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100806</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>DOSE TITRATION</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>DOSE TITRATION</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100820</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>DOSE TITRATION</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100906</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100414</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100429</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100708</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100805</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100805</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100709</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100805</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUVELA</medicinalproduct>
        <drugdosagetext>ADEQUATE DOSE</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>HYPERKERATOSIS PALMARIS AND PLANTARIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091030</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100306</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RINDERON VG</medicinalproduct>
        <drugdosagetext>ADEQUATE DOSE</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ECZEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091224</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080820</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>1 SHEET</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100305</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFDITOREN PIVOXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BURSITIS INFECTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100817</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORCAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BURSITIS INFECTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100817</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFAMEZIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BURSITIS INFECTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100807</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFAMEZIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100730</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFAMEZIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100802</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFDITOREN PIVOXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100804</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFDITOREN PIVOXIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100817</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORCAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100804</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORCAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100817</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135351-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ABBOTT-10P-144-0687645-00</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULATION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID SYRUP</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018082</drugauthorizationnumb>
        <drugindication>PARTIAL SEIZURES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID SYRUP</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018082</drugauthorizationnumb>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENYLHYDANTOIN</medicinalproduct>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>L-CARNITINE</medicinalproduct>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIRACETAM</medicinalproduct>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135352-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-10P-056-0688524-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL GROWTH RESTRICTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR SOFT GELATIN CAPSULES</medicinalproduct>
        <drugauthorizationnumb>020945</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARUNAVIR</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091126</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135353-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101107970</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135354-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA070809</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>62.58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IDIOPATHIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME RATIO DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STENT PLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101014</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101014</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135355-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010159920</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>45.805</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URINE ABNORMALITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOVIAZ</medicinalproduct>
        <drugauthorizationnumb>022030</drugauthorizationnumb>
        <drugdosagetext>8 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLADDER DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135356-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-PFIZER INC-2010160170</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>HYPERBILIRUBINAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>37.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101002</drugenddate>
        <drugtreatmentduration>477</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135357-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010162186</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIKOSYN</medicinalproduct>
        <drugauthorizationnumb>020931</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135358-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010162188</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>96.145</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>10 MG, DAILY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>20 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugdosagetext>20 MG, DAILY</drugdosagetext>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MOOD ALTERED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>0.5 MG, AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONTRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>OBESITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135359-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2010148739</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTOTEC</medicinalproduct>
        <drugbatchnumb>A03777</drugbatchnumb>
        <drugauthorizationnumb>019268</drugauthorizationnumb>
        <drugdosagetext>50 UG, SINGLE</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>LABOUR INDUCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARDYFERON</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135360-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160645</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>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135361-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2010161548</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROIDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100915</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135362-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-PFIZER INC-2010029869</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTATIC RENAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUNITINIB MALATE</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135363-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-PFIZER INC-2009184422</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUNITINIB MALATE</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>37.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEVUDINE</medicinalproduct>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090227</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135364-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PFIZER INC-2010083559</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>37.5 MG, 1X/DAY</drugdosagetext>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SORIATANE</medicinalproduct>
        <drugdosagetext>3X/DAY</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135365-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-PFIZER INC-2010163035</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135366-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-PFIZER INC-2010143147</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>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIBRAMYCIN</medicinalproduct>
        <drugauthorizationnumb>050007</drugauthorizationnumb>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIBRAMYCIN</medicinalproduct>
        <drugauthorizationnumb>050007</drugauthorizationnumb>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135367-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-PFIZER INC-2010162606</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</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>20081028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081101</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135368-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2010159958</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>TAHOR</medicinalproduct>
        <drugbatchnumb>1038059F</drugbatchnumb>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135369-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010138882</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BETA-D-GLUCAN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES INSIPIDUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOPHTHALMITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugauthorizationnumb>021267</drugauthorizationnumb>
        <drugdosagetext>350 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101027</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugauthorizationnumb>021267</drugauthorizationnumb>
        <drugdosagetext>200 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>SYSTEMIC CANDIDA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugauthorizationnumb>021267</drugauthorizationnumb>
        <drugdosagetext>150 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101125</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugdosagetext>500 MG, DAY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>CENTRAL NERVOUS SYSTEM LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101025</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
        <drugdosagetext>15 ML X 6 TO 8 TIMES, DAY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>DRUG DETOXIFICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101027</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
        <drugdosagetext>3 G, DAY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
        <drugindication>FEBRILE NEUTROPENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEYLON</medicinalproduct>
        <drugdosagetext>40 ML, 3-4 TIMES</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>DRUG DETOXIFICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101026</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEYLON</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAMOX</medicinalproduct>
        <drugdosagetext>500 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101027</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FULCALIQ</medicinalproduct>
        <drugdosagetext>1003 ML, DAY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>NUTRITIONAL SUPPORT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101027</drugenddate>
        <drugtreatmentduration>72</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BICARBON</medicinalproduct>
        <drugdosagetext>500 ML, 3-4 TIMES</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>DETOXIFICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101026</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAXIZON</medicinalproduct>
        <drugdosagetext>100 MG, 1-2 TIMES</drugdosagetext>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101026</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAXIZON</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TPN ELECTROLYTES IN PLASTIC CONTAINER</medicinalproduct>
        <drugdosagetext>500 ML, 3X/DAY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>NUTRITIONAL SUPPORT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOPTOL</medicinalproduct>
        <drugdosagetext>1 GTT, 1X/DAY</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugdosagetext>1 UNK, 1X/DAY</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZOPT</medicinalproduct>
        <drugdosagetext>1 GTT, 2X/DAY</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYALEIN</medicinalproduct>
        <drugdosagetext>1 UNK, 4-5 TIMES</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>CONJUNCTIVAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135370-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010137634</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>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULPERAZON</medicinalproduct>
        <drugauthorizationnumb>050551</drugauthorizationnumb>
        <drugdosagetext>2 G</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>ENTEROCOLITIS BACTERIAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101025</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADONA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135371-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJCH-2010027436</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUBRIDERM ADVANCED THERAPY LOTION</medicinalproduct>
        <drugbatchnumb>0600C</drugbatchnumb>
        <drugdosagetext>TEXT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>ACCIDENTAL EXPOSURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135373-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010065125</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLOGICAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>50 MG, CYCLIC</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>50 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>81 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135374-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010135352</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>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugauthorizationnumb>019787</drugauthorizationnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDENALIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERBESSER</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135375-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160621</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugauthorizationnumb>050467</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135376-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MILLENNIUM PHARMACEUTICALS, INC.-2010-05582</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HERPES SIMPLEX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugauthorizationnumb>021602</drugauthorizationnumb>
        <drugdosagetext>1.0 MG/M2, CYCLIC</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>9 MG/M2, CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>20 MG, CYCLIC</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135377-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20101108910</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR SKILLS IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AGGRESSION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugdosagetext>50 MG IN THE MORNING / 25 MG IN THE EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AGGRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AGGRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANDROCUR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LARGACTIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LARGACTIL</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>AGITATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THERALENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAFALGAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135378-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20101104980</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>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>7 DOSES ADMINISTERED SUBSEQUENTLY, ON UNKNOWN DATES; DISCONTINUED AFTER THE 8TH INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135379-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20101109018</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135380-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101108936</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>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135381-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20100900243</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>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFUSE LARGE B-CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <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>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135382-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20100403870</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICES OESOPHAGEAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>9RMKA85501</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135383-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-JNJFOC-20100703169</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</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>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELITIS</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>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALVEDON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBRUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TROMBYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VISCOTEARS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICHEW D3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135384-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20101200408</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>CONGESTIVE CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIATEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLUPRED</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135387-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2010SE44821</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>STENT PLACEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135388-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC.-2010-RO-01570RO</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugbatchnumb>NR</drugbatchnumb>
        <drugauthorizationnumb>070979</drugauthorizationnumb>
        <drugdosagetext>28 ML</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPRAVENTRICULAR TACHYCARDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101129</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135389-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13532BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC 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>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135390-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR201011005092</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOPHLEBITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100219</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135391-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011003338</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRASUGREL HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugdosagetext>25 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>40 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100912</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugdosagetext>15000 IU, 3/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101009</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135392-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201003006114</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>500 MG/M2, DAY 1 EVERY 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100218</drugenddate>
        <drugtreatmentduration>64</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>500 MG/M2, DAY 1 EVERY 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100311</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>6 AUC, DAY 1 EVERY 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100218</drugenddate>
        <drugtreatmentduration>64</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>15 MG/KG, DAY 1 EVERY 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100218</drugenddate>
        <drugtreatmentduration>64</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>15 MG/KG, DAY 1 EVERY 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100311</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>600 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091023</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>1000 UG, 9 WKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100326</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
        <drugdosagetext>800 MG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>1000 MG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091023</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091023</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugdosagetext>10 MG, AS NEEDED</drugdosagetext>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugdosagetext>6 MG, UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091218</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugdosagetext>150 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLOW-MAG</medicinalproduct>
        <drugdosagetext>UNK, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOMAGNESAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>4 MG/KG, 2/D</drugdosagetext>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091216</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135393-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR201008004200</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100926</drugenddate>
        <drugtreatmentduration>259</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135394-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR201011005411</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>96</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CLAVICLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100518</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135395-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ELI_LILLY_AND_COMPANY-IT201011005075</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135396-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201010005375</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>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRASUGREL HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100529</drugstartdate>
      </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>ATIVAN</medicinalproduct>
        <drugdosagetext>1.5 MG, 3/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>500 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>125 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAXSEED OIL</medicinalproduct>
        <drugdosagetext>1 OTHER, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugdosagetext>500 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugdosagetext>1 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugdosagetext>0.4 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugdosagetext>135 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135397-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201005001262</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID ADENOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A685003C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090310</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A728051C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090310</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RYTHMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135399-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-ELI_LILLY_AND_COMPANY-CH201010002386</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100928</drugenddate>
        <drugtreatmentduration>70</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIMAGON-D 3</medicinalproduct>
        <drugdosagetext>1 D/F, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>600 IU, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>300 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORASEMID</medicinalproduct>
        <drugdosagetext>5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORASEMID</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAMON</medicinalproduct>
        <drugdosagetext>240 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EICOSAPEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135401-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13538BP</companynumb>
    <primarysource>
      <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>002584A</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135402-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201007002350</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.887</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL RECESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMOBILE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSITIVITY OF TEETH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A713107C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A713107C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIDOPHILUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAXSEED OIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135403-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201006007307</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>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugdosagetext>35 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100916</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135404-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR201006007130</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOPHLEBITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100323</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135405-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006768</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</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>7135406-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-AMGEN-KDL438408</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODULE ON EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>63 A?G, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>250 A?G, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135408-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101101010</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALCOHOL POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALCOHOL WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS MEDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>USTEKINUMAB</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>USTEKINUMAB</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOPROFEN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135409-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US81671</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOBI</medicinalproduct>
        <drugauthorizationnumb>050753</drugauthorizationnumb>
        <drugdosagetext>300 MG, BID</drugdosagetext>
        <drugindication>CYSTIC FIBROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENEMA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135410-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101120</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US79713</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100710</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135411-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010AU18061</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PANCREATIC ENZYMES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STI571/CGP57148B T35717+TAB</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>600MG DAILY DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101027</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STI571/CGP57148B T35717+TAB</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STI571/CGP57148B T35717+TAB</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101126</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135412-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2010158343</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>200 MG, 1X/DAY</drugdosagetext>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101104</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ABDOMINAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135413-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-PFIZER INC-2010162314</companynumb>
    <primarysource>
      <reportercountry>FINLAND</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>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, 1X/DAY (DAYS 1-3)</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, 2X/DAY (DAYS 4-7)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>1 MG, 2X/DAY (SINCE DAY 8 UNTIL THE END OF TREATMENT)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135414-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2009263115</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>DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL RECESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOOSE TOOTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugauthorizationnumb>020714</drugauthorizationnumb>
        <drugdosagetext>5/6 CARTRIDGES DAILY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080325</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135415-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-PFIZER INC-2010161887</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135417-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR23469</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT BREAST LUMP REMOVAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>80 MG, 1 TABLET A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>160 MG, 1 TABLET A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10 MG, 1 TABLET AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAX</medicinalproduct>
        <drugdosagetext>1 TABLET AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
        <drugdosagetext>3 TIMES A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>2 TABLETS A DAY (MORNING AND AFTERNOON)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135418-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006612</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BIOPSY BONE MARROW ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135421-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-JNJFOC-20101002616</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OTITIS MEDIA ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMPONI</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMPONI</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </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>MEDICAL DIET</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135422-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20101109118</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</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>SIMPONI</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135423-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-JNJFOC-20101109089</companynumb>
    <primarysource>
      <reportercountry>IRELAND</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMPONI</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135424-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101006215</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>129.28</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135425-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RU-JNJFOC-20101101366</companynumb>
    <primarysource>
      <reportercountry>RUSSIAN FEDERATION</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>EMBOLISM ARTERIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VESSEL DUE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135426-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20100902799</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>101</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DACTYLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135427-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJCH-2010026907</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>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISTERINE WHITENING PLUS RESTORING FLUORIDE RINSE</medicinalproduct>
        <drugbatchnumb>2360LZ</drugbatchnumb>
        <drugdosagetext>TEXT:ONE CAPFUL ONCE DAILY IN MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DENTAL CARE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135428-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ENDO PHARMACEUTICALS INC.-OPIR20100048</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPANA</medicinalproduct>
        <drugauthorizationnumb>021611</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHANOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135429-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010000512</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>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135430-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-249439USA</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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEAR DROWNING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNAMBULISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugauthorizationnumb>076410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135431-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-256988USA</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 CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM DIFFICILE COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugauthorizationnumb>040333</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEAD AND NECK CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugbatchnumb>09C00216B</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEAD AND NECK CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEAD AND NECK CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MACROGOL</medicinalproduct>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugdosagetext>3X/DAY FOR 13 DAYS</drugdosagetext>
        <drugindication>CLOSTRIDIUM DIFFICILE COLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
        <drugdosagetext>2X/DAY AS NEEDED</drugdosagetext>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135432-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-257931USA</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
        <drugindication>MUSCLE SPASMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080721</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL HYDROCHLORIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE MALEATE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135433-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10110037</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101117</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENDAMUSTINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>OXYGEN SATURATION DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101117</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135434-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20100705369</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACANTHOSIS NIGRICANS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESALAMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
        <drugindication>INFLAMMATORY BOWEL DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135437-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHNY2010GB00526</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL (NCH)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135438-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHNY2010GB00524</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>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL (NCH)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CODEINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135439-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHNY2010GB00527</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL (NCH)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135440-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHNY2010GB00523</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL (NCH)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135441-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHNY2010GB00529</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL (NCH)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135442-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHNY2010GB00528</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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 DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL (NCH)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135443-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHNY2010GB00525</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL (NCH)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CODEINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135446-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006590</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135447-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CEPHALON-2010006255</companynumb>
    <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>DRUG PRESCRIBING ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTORA</medicinalproduct>
        <drugauthorizationnumb>021947</drugauthorizationnumb>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135448-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10111547</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</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDUCTION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM T WAVE INVERSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugdosagetext>12.5 OR 25 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM EXTENDED RELEASE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135449-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ABBOTT-10P-114-0687795-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYELID OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAPULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN PLAQUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135450-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-10P-028-0659652-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAL FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>160 MG (BASELINE)/80 MG (WEEK 2)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100310</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080716</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080716</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REACTINE</medicinalproduct>
        <drugindication>RASH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SWINE FLU VACCINATION MONOVALENT</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SWINE FLU VACCINATION MONOVALENT</medicinalproduct>
        <drugindication>H1N1 INFLUENZA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INFLUENZA</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135452-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0687316-00</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021906</drugauthorizationnumb>
        <drugindication>HIV TEST POSITIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPSICOM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOMOTIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135453-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>BE-JNJFOC-20100702446</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugbatchnumb>ACS0611</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100604</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugbatchnumb>ACS0611</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100604</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTRAPID</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MODURETIC 5-50</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASAFLOW</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERSYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135454-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20101108352</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>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135455-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20100904500</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.31</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100824</drugenddate>
        <drugtreatmentduration>114</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135456-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-JNJFOC-20101106034</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GOLIMUMAB</medicinalproduct>
        <drugdosagetext>THE SUBJECT RECEIVED 6 DOSES</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EBETREXAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135457-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20101005205</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>96</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090421</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135458-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHNY2010GB00521</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL (NCH)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135459-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHNY2010GB00520</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL (NCH)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135460-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHNY2010GB00522</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL (NCH)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CODEINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135461-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2010US18419</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>52.154</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEDRIN (MIGRAINE)</medicinalproduct>
        <drugbatchnumb>10097522</drugbatchnumb>
        <drugauthorizationnumb>020802</drugauthorizationnumb>
        <drugdosagetext>2 DF, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101130</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135462-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2010US18232</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>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THERAFLU WARMING RELIEF COLD + CHEST CONG (NCH)</medicinalproduct>
        <drugbatchnumb>10095414</drugbatchnumb>
        <drugdosagetext>3 TSP, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101124</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THERAFLU WARMING RELIEF COLD + CHEST CONG (NCH)</medicinalproduct>
        <drugindication>UPPER RESPIRATORY TRACT CONGESTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIZANIDINE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135463-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2010US18302</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>DRUG ADMINISTERED AT INAPPROPRIATE SITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR SKILLS IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF REPAIR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugbatchnumb>10086261</drugbatchnumb>
        <drugauthorizationnumb>022122</drugauthorizationnumb>
        <drugdosagetext>UNK, BID</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135464-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2010US18017</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVACID 24 HR</medicinalproduct>
        <drugbatchnumb>23888601</drugbatchnumb>
        <drugauthorizationnumb>022327</drugauthorizationnumb>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ADDISON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID THERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135465-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13610BP</companynumb>
    <primarysource>
      <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>20101202</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135466-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13613BP</companynumb>
    <primarysource>
      <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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135467-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101120</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13126BP</companynumb>
    <primarysource>
      <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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC 150</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021698</drugauthorizationnumb>
        <drugdosagetext>150 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UNEVALUABLE EVENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135468-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-12770BP</companynumb>
    <primarysource>
      <qualification>5</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>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020291</drugauthorizationnumb>
        <drugdosagetext>6 PUF</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135469-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13560BP</companynumb>
    <primarysource>
      <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>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135470-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-DE-06600GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS CHORIORETINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNE RECONSTITUTION SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROTISING RETINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOGEN RESISTANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL FIELD DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APTIVUS</medicinalproduct>
        <drugauthorizationnumb>021814</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>3TC</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STOCRIN</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELZIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135471-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006363</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS ENTEROCOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNOGLOBULINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135473-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200908004184</companynumb>
    <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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A558666C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090728</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A595945C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A728052C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EYE DROPS</medicinalproduct>
        <drugdosagetext>11 D/F, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135474-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-CEPHALON-2010006262</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TREANDA</medicinalproduct>
        <drugauthorizationnumb>022249</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>HODGKIN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100127</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135475-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028515</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>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL OF LIFE SUPPORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNSPECIFIED PAIN MEDICATION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135476-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-CEPHALON-2010006274</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TREANDA</medicinalproduct>
        <drugauthorizationnumb>022249</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090428</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135477-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028694</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135478-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006316</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BONE MARROW DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135482-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028731</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>HYPERPARATHYROIDISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135483-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-AMGEN-QUU435853</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CENTRAL NERVOUS SYSTEM LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGAMENT INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SENSIPAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021688</drugauthorizationnumb>
        <drugdosagetext>90 MG, QD</drugdosagetext>
        <drugindication>HYPERPARATHYROIDISM SECONDARY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135484-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-GBRCT2010006458</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>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANITUMUMAB</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>GASTROOESOPHAGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100720</drugenddate>
        <drugtreatmentduration>61</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN</medicinalproduct>
        <drugdosagetext>400 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPROBASE                          /01007601/</medicinalproduct>
        <drugdosagetext>UNK UNK, PRN</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AQUEOUS                            /00498501/</medicinalproduct>
        <drugdosagetext>UNK UNK, PRN</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135485-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006040</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugdosagetext>40 A?G, Q2WK</drugdosagetext>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100818</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugdosagetext>100 A?G, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101112</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135486-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU320199</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P118867</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P118867</drugbatchnumb>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135487-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AMGEN-UK330042</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANITUMUMAB</medicinalproduct>
        <drugdosagetext>531 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081208</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>75 MG/M2, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090108</drugenddate>
        <drugtreatmentduration>53</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
        <drugdosagetext>4 ML, QD</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE SODIUM</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>8 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081208</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK UNK, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMIZOLE SODIUM</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLYETHYLENE GLYCOL</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM PICOSULFATE</medicinalproduct>
        <drugdosagetext>UNK UNK, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISACODYL</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090106</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090112</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>2.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081221</drugenddate>
        <drugtreatmentduration>48</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMILORID COMP. ^RATIOPHARM^</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081104</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135488-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-AMGEN AB-KDC412088</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DENOSUMAB</medicinalproduct>
        <drugdosagetext>1.7 ML, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091202</drugenddate>
        <drugtreatmentduration>114</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AROMASIL</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135489-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028739</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101122</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135493-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006603</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>NPLATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135494-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJCH-2010027188</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>74.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEMICAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOOSE TOOTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISTERINE TOTAL CARE PLUS WHITENING</medicinalproduct>
        <drugbatchnumb>1170LT</drugbatchnumb>
        <drugdosagetext>TEXT:1 TO 1.5 TEASPOONFUL ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DENTAL CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135496-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028915</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>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101121</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135497-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-AVENTIS-2010SA066119</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>67</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED THERAPY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100318</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101029</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOSENN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CILOSTAZOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESILATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPINASTINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE BUTYRATE</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DERMATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE HEAVY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELBINAC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100318</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135498-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ABBOTT-10P-144-0681331-00</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ERYTHRODERMIC PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAL ANTI-DIABETIC DRUGS (NOT SPECIFIED)</medicinalproduct>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLORICR</medicinalproduct>
        <drugindication>BLOOD URIC ACID INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135499-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CL-ABBOTT-10P-034-0687859-00</companynumb>
    <primarysource>
      <reportercountry>CHILE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAESTHETIC COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVORANE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020478</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFAZOLIN</medicinalproduct>
        <drugdosagetext>ONE DOSE, ROUTE: EV</drugdosagetext>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
        <drugdosagetext>ONE DOSE, ROUTE: EV</drugdosagetext>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>ONE DOSE, ROUTE: EV</drugdosagetext>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HCL</medicinalproduct>
        <drugdosagetext>ONE DOSE, ROUTE: EV</drugdosagetext>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugdosagetext>ONE DOSE, ROUTE: EV</drugdosagetext>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugdosagetext>ONE DOSE, ROUTE: EV</drugdosagetext>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCURONIO</medicinalproduct>
        <drugdosagetext>ONE DOSE, ROUTE: EV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOBUPIVACAINE</medicinalproduct>
        <drugdosagetext>ONE DOSE, ROUTE: EV</drugdosagetext>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
        <drugdosagetext>ONE DOSE, ROUTE: EV</drugdosagetext>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101124</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135500-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-10P-020-0624374-00</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID FACTOR INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugindication>CARDIOVASCULAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</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>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN 150MG/RANITIDINE150MG/DIACEREIN 50MG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN 150MG/RANITIDINE150MG/DIACEREIN 50MG</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN 150MG/RANITIDINE 150MG/CYCLOBENZAPRINE 10MG/PAROXETINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN 150MG/RANITIDINE 150MG/CYCLOBENZAPRINE 10MG/PAROXETINE</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMABAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEFLAZACORT/RANITIDINE/HYDROCHLOROTHIAZIDE/FOLIC ACID</medicinalproduct>
        <drugdosagetext>9MG/150MG/50MG/2MG EVERY 24 HOURS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE/CYCLOBENZAPRINE/AMITRIPTYLINE/DEFLAZACORT/RANITIDINE</medicinalproduct>
        <drugdosagetext>PAROXETINE30MG/CYCLOBENZAPRINE 10MG/ AMITRIPTYLINE 10MG/ DEFLAZACORT/RANITIDINE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135501-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>UA-ABBOTT-10P-269-0687330-00</companynumb>
    <primarysource>
      <reportercountry>UKRAINE</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>AUTOIMMUNE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYMYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE ABSENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS CEREBRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS NECROTISING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METIPRED</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135503-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028946</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101122</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135504-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR201011005845</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL TONSILLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135505-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ELI_LILLY_AND_COMPANY-ES201011005839</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDYL</medicinalproduct>
        <drugdosagetext>1 D/F, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>1 D/F, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NATECAL</medicinalproduct>
        <drugdosagetext>1 D/F, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugdosagetext>1 PUFF D/F, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135506-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201009004499</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100805</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100826</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100826</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SSRI</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>650 MG, AS NEEDED</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135507-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201009004556</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>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYASTHENIA GRAVIS CRISIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135508-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ELI_LILLY_AND_COMPANY-BR201011001458</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>OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135509-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201005003141</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>ABDOMINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAILURE TO THRIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, UNKNOWN</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100406</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135510-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201010007031</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRIGEMINAL NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>30 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>TRIGEMINAL NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA /USA/</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135511-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ELI_LILLY_AND_COMPANY-IT201011005554</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135512-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA064595</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>108.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PHOTOPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL FIELD DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANOLAZINE</medicinalproduct>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESILATE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANXENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCERYL TRINITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135515-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2010SE35184</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>102.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ENDODONTIC PROCEDURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135516-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200911006571</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.887</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JUGULAR VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SIALOADENITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A719441C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASACORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135517-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201009004201</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>SEBACEOUS ADENOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A719441C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100409</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORENCIA</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugindication>SUPRAVENTRICULAR TACHYCARDIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugdosagetext>UNK, EACH EVENING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>UNK, EACH EVENING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
        <drugindication>SUPRAVENTRICULAR TACHYCARDIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135518-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ELI_LILLY_AND_COMPANY-GB201011006065</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>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
        <drugtreatmentduration>549</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135519-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE201011005472</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CALCINOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART VALVE OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100519</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135520-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE201010006639</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>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND SECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100427</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>UNK, 7.5 - 10 MG DAILY (1/D)</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135521-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011005731</companynumb>
    <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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYMENORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>A693929A</drugbatchnumb>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135522-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011005999</companynumb>
    <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>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>183</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135523-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201008005866</companynumb>
    <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>HIP SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100913</drugstartdate>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A713107C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A713108C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135524-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011005609</companynumb>
    <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>ANTINUCLEAR ANTIBODY INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEROIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKELAXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135525-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ELI_LILLY_AND_COMPANY-CA201009008234</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>COLON CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135526-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ELI_LILLY_AND_COMPANY-ES201011006308</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL VASCULAR THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTRUMA</medicinalproduct>
        <drugauthorizationnumb>020815</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135528-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011005913</companynumb>
    <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>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135529-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011005622</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APGAR SCORE LOW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFANTILE APNOEIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEARNING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>018936</drugauthorizationnumb>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>018936</drugauthorizationnumb>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135530-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101120</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201011005389</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135531-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR201011005442</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100301</drugenddate>
      </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>20100808</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>30 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LARGACTIL</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THERALENE</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100906</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135532-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR201011005848</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>INTESTINAL RESECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135533-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201009005632</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.689</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A723779C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135534-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201011006814</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>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS PARALYTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101026</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135535-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ELI_LILLY_AND_COMPANY-AU201011005373</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135536-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201009003284</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>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN EPITHELIAL CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>020815</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135537-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201010002162</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>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100810</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>30 MG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100909</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100923</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>20 MG, QOD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101002</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135538-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ELI_LILLY_AND_COMPANY-CA201011006058</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA ZYDIS</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAVIK</medicinalproduct>
        <drugdosagetext>4 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135539-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201009004664</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>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, OTHER</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>5 MG, OTHER</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135540-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201010005401</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100520</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>40 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100603</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>50 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100617</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100927</drugenddate>
        <drugtreatmentduration>102</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIMAS</medicinalproduct>
        <drugdosagetext>400-600MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100927</drugenddate>
        <drugtreatmentduration>389</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>1.5-3MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100927</drugenddate>
        <drugtreatmentduration>809</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESLIN</medicinalproduct>
        <drugdosagetext>25-75MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100927</drugenddate>
        <drugtreatmentduration>753</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYSLEE</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100927</drugenddate>
        <drugtreatmentduration>873</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135541-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201010002405</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>73.651</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>021411</drugauthorizationnumb>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100909</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>021411</drugauthorizationnumb>
        <drugdosagetext>80 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101018</drugenddate>
        <drugtreatmentduration>39</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>1 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>AFFECTIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
        <drugdosagetext>450 D/F, 2/D</drugdosagetext>
        <drugindication>AFFECTIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>2 MG, EACH EVENING</drugdosagetext>
        <drugindication>AFFECTIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135542-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ELI_LILLY_AND_COMPANY-CA201011005762</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE URINARY TRACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF-INJURIOUS IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY HESITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIOLENCE-RELATED SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>30 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, QOD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>A683959</drugbatchnumb>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>1.5 MG, EACH EVENING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORADOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135543-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201009001307</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>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A713107C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100921</drugenddate>
        <drugtreatmentduration>37</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A719441C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135544-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE201011005553</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN ENLARGEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090902</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135545-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH029041</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135546-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006613</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>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135547-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MYLANLABS-2010S1021405</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>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugauthorizationnumb>090868</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDICOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135548-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MYLANLABS-2010S1021415</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugauthorizationnumb>018487</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLENIL MODULITE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-CODAMOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAMINE HCL</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>VITAMIN B COMPLEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135549-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-BAXTER-2010BH029096</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135550-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA071058</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>102</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STENT PLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135551-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MYLANLABS-2010S1021429</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACQUIRED DIAPHRAGMATIC EVENTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIAPHRAGMATIC PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALLORY-WEISS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE STIMULATION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugauthorizationnumb>075281</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CODEINE W/PARACETAMOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135552-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13608BP</companynumb>
    <primarysource>
      <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>20101202</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135553-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13603BP</companynumb>
    <primarysource>
      <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>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135554-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH029107</companynumb>
    <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>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135555-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-12800BP</companynumb>
    <primarysource>
      <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>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC 75</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020520</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101112</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135556-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13378BP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN NATRIURETIC PEPTIDE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135557-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-14857429</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>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENALOG</medicinalproduct>
        <drugauthorizationnumb>011600</drugauthorizationnumb>
        <drugdosagetext>THERAPY DURATION=3DAYS,3TIMES A DAY:ONE TIME BEFORE BEDTIME</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135558-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-14886469</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>KENALOG</medicinalproduct>
        <drugauthorizationnumb>011600</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135559-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100512</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15102031</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENALOG</medicinalproduct>
        <drugauthorizationnumb>011600</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135560-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100722</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15205628</companynumb>
    <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 ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENALOG</medicinalproduct>
        <drugauthorizationnumb>011600</drugauthorizationnumb>
        <drugdosagetext>9 INFUSIONS</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135561-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100812</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15239155</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</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>KENALOG</medicinalproduct>
        <drugauthorizationnumb>011600</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135562-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100813</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15239981</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENALOG</medicinalproduct>
        <drugauthorizationnumb>011600</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135563-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15294721</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>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENALOG</medicinalproduct>
        <drugauthorizationnumb>011600</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135564-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15318876</companynumb>
    <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>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENALOG</medicinalproduct>
        <drugauthorizationnumb>011600</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135565-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MYLANLABS-2010S1021560</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>JATROSOM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugauthorizationnumb>078626</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135566-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MYLANLABS-2010S1021560</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>ALCOHOL POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>JATROSOM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugauthorizationnumb>076540</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135568-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH029111</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135569-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MYLANLABS-2010S1021560</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>JATROSOM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugauthorizationnumb>075207</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugauthorizationnumb>075207</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugauthorizationnumb>075207</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugauthorizationnumb>075207</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135570-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MYLANLABS-2010S1021560</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>JATROSOM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugauthorizationnumb>075577</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugauthorizationnumb>075577</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugauthorizationnumb>075577</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugauthorizationnumb>075577</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135571-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101121</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA071284</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135572-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MYLANLABS-2010S1021567</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERAMMONAEMIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INBORN ERROR OF METABOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugauthorizationnumb>077254</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</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>2</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSPHENYTOIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135573-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AMGEN-FRASP2010006293</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELL DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VECTIBIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135574-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MYLANLABS-2010S1021632</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUETIAPINE FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVERDOSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVERDOSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugauthorizationnumb>070317</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVERDOSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVERDOSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135575-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MYLANLABS-2010S1021632</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUETIAPINE FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVERDOSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugauthorizationnumb>090514</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVERDOSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVERDOSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVERDOSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135576-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MYLANLABS-2010S1021632</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUETIAPINE FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVERDOSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugauthorizationnumb>071405</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVERDOSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVERDOSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVERDOSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135577-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MYLANLABS-2010S1021754</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>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugauthorizationnumb>075969</drugauthorizationnumb>
        <drugdosagetext>USE STATED AS LONG-TERM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCET                             /01554201/</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135578-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MYLANLABS-2010S1021754</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>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugauthorizationnumb>075973</drugauthorizationnumb>
        <drugdosagetext>USE STATED AS LONG-TERM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCET                             /01554201/</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135581-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MYLANLABS-2010S1021769</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>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugdosagetext>125 X 500MG TABLETS; TOTAL DOSE }1000 MG/KG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTENTIONAL OVERDOSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugauthorizationnumb>074046</drugauthorizationnumb>
        <drugindication>INTENTIONAL OVERDOSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIAPRIDE</medicinalproduct>
        <drugindication>INTENTIONAL OVERDOSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135582-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MYLANLABS-2010S1021769</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>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugdosagetext>125 X 500MG TABLETS; TOTAL DOSE }1000 MG/KG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTENTIONAL OVERDOSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugauthorizationnumb>074215</drugauthorizationnumb>
        <drugindication>INTENTIONAL OVERDOSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIAPRIDE</medicinalproduct>
        <drugindication>INTENTIONAL OVERDOSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135583-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0688012-00</companynumb>
    <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>ZEMPLAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021606</drugauthorizationnumb>
        <drugindication>HYPERPARATHYROIDISM SECONDARY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEMPLAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021606</drugauthorizationnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135584-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0674276-00</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>FOETAL GROWTH RESTRICTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020945</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100218</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREZISTA</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100218</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100603</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135585-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0688167-00</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>
      <patientweight>74.91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VOCAL CORD PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100906</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135586-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DO-ABBOTT-10P-CLI-0687751-00</companynumb>
    <primarysource>
      <reportercountry>DOMINICAN REPUBLIC</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVAL ER 500 MG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021168</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVAL ER 500 MG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021168</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVAL ER 500 MG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021168</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135587-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-10P-056-0687576-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE ABNORMALITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135588-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-10P-167-0687696-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>115</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135589-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-10P-167-0687718-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061219</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135590-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0687743-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135591-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0687735-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135592-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-10P-167-0687828-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FOOD POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS SALMONELLA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051129</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135593-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-10P-167-0687673-00</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>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135594-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0687731-00</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>PREMATURE LABOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
        <drugdosagetext>1 PILL, 1 DAILY, STARTED AT 6 WEEKS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREGNANCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugdosagetext>1 DAILY, STARTED AT 6 WEEKS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREGNANCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONDOM NOS</medicinalproduct>
        <drugdosagetext>NO SPERMICIDE, VAGINAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080618</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>1 DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080514</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>1 DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>1 DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>1 DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081218</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>1 DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081229</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugdosagetext>1 DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMATURE LABOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICATION TO STOP LABOR NOS</medicinalproduct>
        <drugdosagetext>ADMINISTERED</drugdosagetext>
        <drugindication>PREMATURE LABOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICATION TO STOP LABOR NOS</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
        <drugdosagetext>4 TOTAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091218</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>1 DAY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080514</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080514</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135595-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-10P-167-0687549-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE CELL CARCINOMA OF THE RESPIRATORY TRACT STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACITRETIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135596-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010NL79762</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG, 1DD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100803</drugenddate>
        <drugtreatmentduration>101</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITROFURANTOIN</medicinalproduct>
        <drugdosagetext>50 MG, 4DD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100614</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugdosagetext>150 MG, 1DD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100612</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
        <drugdosagetext>1-2DD25 MG, AS NEEDED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
        <drugdosagetext>1DD 20MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMCINOLONE ACETONIDE</medicinalproduct>
        <drugdosagetext>1MG/G, 2DD1</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100630</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETOMACROGOL (S)</medicinalproduct>
        <drugdosagetext>2DD1</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugdosagetext>1DD 5MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100705</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNAPAUSE E3</medicinalproduct>
        <drugdosagetext>1DD 0.5MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100727</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLECALCIFEROL</medicinalproduct>
        <drugdosagetext>1DD 1ML</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100716</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135597-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US78309</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135598-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US81345</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL STROMAL TUMOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101121</drugenddate>
        <drugtreatmentduration>377</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135599-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP76500</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>CHRONIC GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEM CELL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE BIPHENOTYPIC LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135600-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US80057</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANKLE FRACTURE</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135601-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201010003083</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53.515</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOCTURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A638543C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101006</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUPER B COMPLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAXSEED OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYSINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORTHALIDONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135602-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011006026</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A723778C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135603-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011006457</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>BODY TEMPERATURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</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>7135604-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011005746</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOMICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>021411</drugauthorizationnumb>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135605-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011006056</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>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135606-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011006055</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>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135607-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011006186</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUMBAR SPINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>BONE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135608-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201010006267</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>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101015</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135609-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201010000719</companynumb>
    <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>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</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>7135610-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201010006620</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>48.526</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUMBAR VERTEBRAL FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A723779D</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135611-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011000186</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 OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>0.088 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
        <drugdosagetext>180 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
        <drugdosagetext>100 MG, 2/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135612-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011006256</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>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A685003C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135613-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201010000847</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>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THALAMIC INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A728052C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135614-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011006053</companynumb>
    <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>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100722</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135615-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011002415</companynumb>
    <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>BREAKTHROUGH PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100912</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A728052C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugdosagetext>0.4 MG, EACH EVENING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugdosagetext>0.1 MG, 2/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>40 MG, AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRANDIN</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>5 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>40 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugdosagetext>12.5 MG, 2/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KINERET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GOLD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135616-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201010004552</companynumb>
    <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>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT RANGE OF MOTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A723778C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMETANIDE</medicinalproduct>
        <drugdosagetext>20 MG, DAY AND NIGHT</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>1 MG, EACH EVENING</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
        <drugdosagetext>2 D/F, EACH EVENING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
        <drugdosagetext>30 MG, MORNING AND EVENING</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG, EACH MORNING</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>2.5 MG, IN THE MORNING AND NIGHT</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugdosagetext>15 MG, EACH EVENING</drugdosagetext>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOLAZONE</medicinalproduct>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugdosagetext>40 U, 2/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugdosagetext>SLIDING SCALE</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135617-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011006208</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLON CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIAZAC                             /00489702/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZAROXOLYN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICRO-K</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135618-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ELI_LILLY_AND_COMPANY-IT201011005486</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugdosagetext>1700 MG, PER CYCLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NASOPHARYNGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100930</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEURSIL</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135619-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201011006282</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>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135620-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-AMGEN-ESPSP2010006762</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>THROMBOCYTOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100304</drugenddate>
        <drugtreatmentduration>294</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135621-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2010143372</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</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>7135622-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010125591</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugindication>PAIN IN EXTREMITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugindication>SPINAL COLUMN STENOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135623-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010123893</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CSF PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSMOPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHONOPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGVISOMANT</medicinalproduct>
        <drugauthorizationnumb>021106</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>EWING'S SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100926</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CP-751,871</medicinalproduct>
        <drugdosagetext>2026 MG, DAY 1 AND 2 OF CYCLE 1, DAY 1 OF CYCLE 2 AND EVERY 3 WEEKS ONWARD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>EWING'S SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugdosagetext>400 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE</medicinalproduct>
        <drugdosagetext>90-120 MG, EVERY 4 HOURS AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000911</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135624-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2010152954</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>150 MG, 1X/DAY</drugdosagetext>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugdosagetext>2 MG, 1X/DAY</drugdosagetext>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101102</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135625-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-GENENTECH-306323</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>100 UNK, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071230</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARADOIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSCAL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLOROQUINE PHOSPHATE</medicinalproduct>
        <drugdosagetext>400 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>25 A?G, UNK</drugdosagetext>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANCORON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDROCORTISONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135626-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAXTER-2010BH028270</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PERITONITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>GLOMERULONEPHRITIS CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101114</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135627-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GENENTECH-310101</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100503</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100628</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135628-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GENENTECH-310095</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>EYELID INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>0.05 ML, UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100728</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135629-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GENENTECH-306020</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>375 MG, Q2W</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090617</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEO-DUR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNIPHYL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090617</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMITT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMAC (JAPAN)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPIVERIN HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM PHOSPHATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090828</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135630-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13622BP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135631-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13348BP</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135632-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>LT-GENENTECH-310119</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1 G/M2, Q21D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135633-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0688540-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.36</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL FOR DATES BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020945</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090924</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARUNAVIR</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090924</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090822</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135634-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-AVENTIS-2010SA072481</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLAST CELLS PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELOCYTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AORTIC VALVE REPLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100709</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN K TAB</medicinalproduct>
        <drugindication>PULMONARY EMBOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135635-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-AMGEN-CHESP2010005791</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RAYNAUD'S PHENOMENON</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugdosagetext>30 MILLION IU, PER CHEMO REGIM</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLEOMYCIN SULFATE</medicinalproduct>
        <drugdosagetext>19000 IU, UNK</drugdosagetext>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELBE</medicinalproduct>
        <drugdosagetext>6 MG, UNK</drugdosagetext>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIREAD                             /01490001/</medicinalproduct>
        <drugdosagetext>245 MG, UNK</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISENTRESS</medicinalproduct>
        <drugdosagetext>400 MG, UNK</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugindication>HODGKIN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DACARBAZINE</medicinalproduct>
        <drugdosagetext>735 MG, UNK</drugdosagetext>
        <drugindication>HODGKIN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101010</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101003</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100803</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135636-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-A03200701701</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>82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBARACHNOID HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugdosagetext>UNIT DOSE: 75 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STENT PLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugdosagetext>UNIT DOSE: 75 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugdosagetext>UNIT DOSE: 75 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugdosagetext>UNIT DOSE: 75 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STENT PLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135637-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-EISAI INC.-E7389-01070-CLI-US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>100</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>E7389 (BOLD)</medicinalproduct>
        <drugauthorizationnumb>201532</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101013</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101014</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHEST PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROBAXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugindication>VOMITING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RASH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
        <drugindication>VOMITING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILK OF MAGNESIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILK OF MAGNESIA</medicinalproduct>
        <drugindication>VOMITING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RASH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>RASH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTRISONE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>RASH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101117</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135638-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-WATSON-2010-15424</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>74</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARKINSONISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>076928</drugauthorizationnumb>
        <drugdosagetext>75 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</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>CETRABEN                           /01561901/</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-DYDRAMOL</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>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135639-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-WATSON-2010-15425</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANEURYSM RUPTURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATICA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>017064</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135640-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AMGEN-DEUSP2010006678</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA PNEUMOCOCCAL</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>20080701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>20 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </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>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPINAL COLUMN STENOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135641-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006984</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>NPLATE</medicinalproduct>
        <drugindication>THROMBOCYTOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100529</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135642-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-ABBOTT-09P-066-0600699-00</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090911</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135643-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ABBOTT-10P-144-0658839-00</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEMYELINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100609</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135644-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-10P-056-0678874-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA INFECTIOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021906</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100315</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135645-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-721201</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FURUNCLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2A</medicinalproduct>
        <drugdosagetext>FORM: PRE-FILLED SYRINGE;</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2A</medicinalproduct>
        <drugdosagetext>WEEK 37 OF TREATMENT (EVERY FRIDAY)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugdosagetext>DIVIDED DOSES;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugdosagetext>DIVIDED DOSES, WEEK 37 OF TREATMENT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugdosagetext>FREQUENCY: QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugdosagetext>FREQUENCY: QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135646-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-635043</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>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED.</drugbatchnumb>
        <drugdosagetext>15 MG/KG, DAY 1 EVERY 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090429</drugenddate>
        <drugtreatmentduration>64</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED.</drugbatchnumb>
        <drugdosagetext>LAST DOSE PRIOR TO SAE: 3 MAY 2009</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090429</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPOTECAN HCL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>2.3 MG/M2, FREQUENCY :FOR CONSECUTIVE 5 DAYS ON DAY 1-5 EVERY 21 DAYS  LAST DOSE: 3 MAY 2009</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090503</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL SULFATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081009</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081009</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIPOTRIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESILATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMETEROL XINAFOATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOLASETRON MESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MACROGOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARBEPOETIN ALFA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUPIROCIN CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135647-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ROCHE-706918</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA EYELIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL DRYNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACTEMRA</medicinalproduct>
        <drugdosagetext>FORM: INFUSION; FIRST INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACTEMRA</medicinalproduct>
        <drugdosagetext>SECOND INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACTEMRA</medicinalproduct>
        <drugdosagetext>THIRD INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACTEMRA</medicinalproduct>
        <drugdosagetext>FOURTH INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACTEMRA</medicinalproduct>
        <drugdosagetext>FIFTH INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100520</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACTEMRA</medicinalproduct>
        <drugdosagetext>SIXTH INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100629</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLARAMINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135648-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US79626</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>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135649-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101020</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TH-ROCHE-727725</companynumb>
    <primarysource>
      <reportercountry>THAILAND</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>APLASIA PURE RED CELL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRCERA</medicinalproduct>
        <drugbatchnumb>H0462H02, H0466H01,H0467H01,H0468H+</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRCERA</medicinalproduct>
        <drugbatchnumb>H0462H02, H0466H01,H0467H01,H0468H+</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100504</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRCERA</medicinalproduct>
        <drugbatchnumb>H0462H02, H0466H01,H0467H01,H0468H+</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100805</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRCERA</medicinalproduct>
        <drugbatchnumb>H0462H02, H0466H01,H0467H01,H0468H+</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100822</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECORMON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETALOC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANIDIP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDERGINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugdosagetext>VYTORIN 10/40</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHALKCAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KIDMIN</medicinalproduct>
        <drugdosagetext>200 ML, HEMODIALYSIS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODA MINT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICPLEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135650-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-739982</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>08 OCT 2010 MOST RECENT DOSE GIVEN, CURRENT CYCLE 8</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>FOR 14 DAYS OF 21 DAY CYCLE.  08 OCT 2010, MOST RECENT DOSE GIVEN, CURRENT CYCLE 8</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>25% DOSE REDUCTION, MOST RECENT DOSE 22 OCT 2010</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>DOSE REPORTED AS 4G</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135651-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010US17233</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASPIRATION PLEURAL CAVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROID CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100729</drugenddate>
        <drugtreatmentduration>84</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101109</drugenddate>
        <drugtreatmentduration>103</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESIPRAMINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135652-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GENENTECH-309918</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>LUCENTIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135653-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-740893</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100811</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100811</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135654-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ROCHE-744559</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PUSTULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACTEMRA</medicinalproduct>
        <drugdosagetext>FORM: INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135655-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GENENTECH-307363</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135656-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-744943</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>ACQUIRED HAEMOPHILIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135657-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-ROCHE-745184</companynumb>
    <primarysource>
      <reportercountry>GREECE</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>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101129</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135658-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GENENTECH-306689</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>B6081/B6024</drugbatchnumb>
        <drugdosagetext>147 MG, Q28D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100907</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>B6081/B6024</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORAMBUCIL</medicinalproduct>
        <drugbatchnumb>9D258</drugbatchnumb>
        <drugdosagetext>42 MG, DAYS 1+15</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100907</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORAMBUCIL</medicinalproduct>
        <drugbatchnumb>9D258</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100915</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTRIM</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100915</drugenddate>
        <drugtreatmentduration>41</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MCP</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>30 GTT, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100915</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BINOCRIT</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>30000 IU, 1/WEEK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100904</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135659-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090218</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-745357</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135660-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-ROCHE-745411</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2A</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135661-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GENENTECH-310165</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>LUCENTIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135662-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-745434</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERCALCAEMIA OF MALIGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135663-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-745464</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC STROKE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101126</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101126</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135664-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010AR81746</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</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>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135665-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-745603</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugdosagetext>INFUSION</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugdosagetext>RE-STARTED ON 22 NOV 2010</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135666-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060912</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-745612</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135667-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080513</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-745621</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>AVASTIN</medicinalproduct>
        <drugdosagetext>DOSE, FORM AND FREQUENCY NOT PROVIDED.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135668-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-PFIZER INC-2010156938</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>1</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>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135669-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2010156729</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>DYSGRAPHIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 2X/DAY</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135670-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010153802</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>150 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPINAL COLUMN STENOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135671-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2010147800</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>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101022</drugenddate>
        <drugtreatmentduration>1483</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugauthorizationnumb>073676</drugauthorizationnumb>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICHEW</medicinalproduct>
        <drugdosagetext>1.25 G, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONIC ACID</medicinalproduct>
        <drugdosagetext>70 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135672-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-PFIZER INC-2010156441</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST HERPETIC NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>75 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST HERPETIC NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101119</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135673-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090409</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-745675</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135674-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13320PF</companynumb>
    <primarysource>
      <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>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135675-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-09695NB</companynumb>
    <primarysource>
      <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>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOCAL CORD POLYP</reactionmeddrapt>
      </reaction>
      <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>20100305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugdosagetext>200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DASEN</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUVELA N</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135676-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-745712</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>RECEIVED 5 TH CYCLE ON 28 APRIL 2009.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPOTECAN</medicinalproduct>
        <drugdosagetext>FREQUENCY: DAYS 1-5. LAST DOSE PRIOR TO SAE: 02 MAY 2009.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGESTROL ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREGABALIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMID-HCL</medicinalproduct>
        <drugdosagetext>DRUG NAME REPORTED AS: METOCLOPRAMID-HYDROCHLORIDE.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135677-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13304BP</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>150 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135678-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20081209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-745713</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135679-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-745724</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>PORTAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135680-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AMGEN-FRASP2010007197</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, WEEKLY</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100430</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135681-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-745759</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>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>CYCLE 4: 31 DEC 2008, INTERUPPTED, LAST DOSE: 04 JAN 2009</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081029</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPOTECAN</medicinalproduct>
        <drugdosagetext>5 CONSECUTIVE DAYS ON DAYS 1-5, LAST DOSE: 04 JAN 2009</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081029</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALUMINUM HYDROXIDE GEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMETEROL XINAFOATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARBEPOETIN ALFA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOLASETRON MESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGESTROL ACETATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135682-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-745762</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICOSE VEIN RUPTURED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>LARGE INTESTINE CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100428</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELPLAT</medicinalproduct>
        <drugdosagetext>NOTE: DOSAGE WAS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFOLINATE</medicinalproduct>
        <drugdosagetext>NOTE: DOSAGE WAS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>NOTE: DOSAGE WAS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135683-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-AVENTIS-2010SA062231</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>
      <patientweight>62.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUDDEN CARDIAC DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED THERAPY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100622</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100820</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100820</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RENIVACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100820</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135684-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-745876</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugdosagetext>NOTE: DOSAGE IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135685-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ROCHE-744908</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL VARICES HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugdosagetext>MEAN DAILY DOSE: 13.4 MG/KG (PLUS OR MINUS 1.0 MG/KG)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2A</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135686-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-745586</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>DOSAGE IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugdosagetext>DOSAGE IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135687-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ABBOTT-09P-114-0578326-00</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090504</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUESTRAN</medicinalproduct>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX</medicinalproduct>
        <drugindication>VITAMIN B1 DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090109</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135688-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101120</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR201011005843</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>
      <patientweight>69</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERIAL STENT INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE URINARY TRACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugbatchnumb>A744149</drugbatchnumb>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANGIOPLASTY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101009</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARDEGIC</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANGIOPLASTY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDENSIEL</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANGIOPLASTY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135689-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-AVENTIS-2010SA069830</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>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITOROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESILATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID /SCH/</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135690-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010157278</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>HEPATITIS FULMINANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugauthorizationnumb>009987</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135691-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2010127868</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>100 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>300 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE EVOHALER</medicinalproduct>
        <drugdosagetext>125 UG, 2 PUFFS TWICE DAILY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL</medicinalproduct>
        <drugdosagetext>2 DF, AS NEEDED</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>0.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULOXETINE</medicinalproduct>
        <drugdosagetext>30 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135692-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-FR-WYE-G04724809</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OROANTRAL FISTULA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMSIROLIMUS</medicinalproduct>
        <drugauthorizationnumb>022088</drugauthorizationnumb>
        <drugdosagetext>25 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091014</drugenddate>
        <drugtreatmentduration>204</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>600 MG 1 TIME EVERY 2 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090909</drugenddate>
        <drugtreatmentduration>169</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRACTAZIN</medicinalproduct>
        <drugdosagetext>.5 TABLET 1 TIME PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPEGIC 1000</medicinalproduct>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugdosagetext>160 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135693-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MY-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-CS-01036MD</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135694-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>BR-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BR-02807BR</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SPINAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>220 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100919</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISADOR</medicinalproduct>
        <drugdosagetext>NR</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135695-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13547BP</companynumb>
    <primarysource>
      <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>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANORECTAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN IRRITATION</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>20101123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG</drugdosagetext>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENERIC FLOMAX - TEVA</medicinalproduct>
        <drugindication>URINARY TRACT DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
        <drugindication>URINARY TRACT DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</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>ALLOPURINOL</medicinalproduct>
        <drugindication>GOUT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
        <drugindication>GOUT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASA</medicinalproduct>
        <drugindication>METABOLIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135696-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0686665-00</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>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091023</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135697-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-10P-087-0682419-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020478</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135698-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GENENTECH-310218</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>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSOPHARYNGEAL NERVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLOSSAL NERVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>QUADRIPLEGIA</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>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPY NOS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135699-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GENENTECH-304482</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>773 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090813</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091014</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENDAMUSTINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>185 MG, Q4W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090814</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENDAMUSTINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENDAMUSTINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091014</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENDAMUSTINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENDAMUSTINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENDAMUSTINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100113</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>125 A?G, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIMETINDENMALEAT</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090917</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090814</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135700-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GENENTECH-310259</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070804</drugenddate>
        <drugtreatmentduration>80</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERBUTALINE SULFATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS NOS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135701-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>LB-GENENTECH-306699</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>POLYMYOSITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135702-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-JP-WYE-H06510108</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANCARON</medicinalproduct>
        <drugauthorizationnumb>018972</drugauthorizationnumb>
        <drugdosagetext>200 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VENTRICULAR TACHYCARDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080622</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANCARON</medicinalproduct>
        <drugauthorizationnumb>018972</drugauthorizationnumb>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080624</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>1.25 MG/DL AT RATE OF 10 ML/MIN</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>VENTRICULAR TACHYCARDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080617</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>1.50 MG/DL AT RATE OF 33 ML/HR</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080617</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>1.50 MG/DL AT RATE OF 17 ML/HR</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080620</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugdosagetext>500 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080623</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOBUTREX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080702</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUTHAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080702</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOREPINEPHRINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080702</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080702</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135703-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101120</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010105478</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>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM</medicinalproduct>
        <drugauthorizationnumb>021540</drugauthorizationnumb>
        <drugdosagetext>5 MG/40 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM</medicinalproduct>
        <drugauthorizationnumb>021540</drugauthorizationnumb>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugdosagetext>16 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZONATATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135704-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GENENTECH-310173</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 ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUTROPIN AQ</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020522</drugauthorizationnumb>
        <drugdosagetext>0.035 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070130</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135705-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-GENENTECH-309929</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</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>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPOTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101022</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135706-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033825</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMTRICITABINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATAZANAVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135707-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GENENTECH-310307</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>3</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>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</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>TERBUTALINE SULFATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135708-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AMGEN-FRASP2010007198</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135709-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ELI_LILLY_AND_COMPANY-ES201011005045</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>930 MG, EVERY 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER STAGE III</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100828</drugenddate>
        <drugtreatmentduration>48</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>870 MG, EVERY 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>139.5 MG, EVERY 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER STAGE III</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100828</drugenddate>
        <drugtreatmentduration>48</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIATION</medicinalproduct>
        <drugdosagetext>2 GY, DAILY (1/D)</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER STAGE III</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100825</drugenddate>
        <drugtreatmentduration>45</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100823</drugenddate>
        <drugtreatmentduration>54</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135710-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ELI_LILLY_AND_COMPANY-CA201011005526</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>A759524A</drugbatchnumb>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135711-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201006002263</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>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>200 D/F, UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135712-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011006615</companynumb>
    <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 HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135713-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ELI_LILLY_AND_COMPANY-IT201011004408</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>500 MG/M2, DAY 1 EVERY 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>75 MG/M2, 1 EVERY 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>7.5 MG/KG, DAY 1 EVERY 21 DAYS</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugindication>BONE PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE</medicinalproduct>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugindication>GASTRIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101011</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135714-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ELI_LILLY_AND_COMPANY-AU201009001950</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugdosagetext>1000 MG/M2, OTHER</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100915</drugenddate>
        <drugtreatmentduration>126</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugdosagetext>REDUCED DOSE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>125 MG/M2, OTHER</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100915</drugenddate>
        <drugtreatmentduration>126</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>REDUCED DOSE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOMIX                            /01475801/</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLLIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLOXYL WITH SENNA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100729</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135715-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201006007307</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>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugdosagetext>35 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100916</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135716-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201008008805</companynumb>
    <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>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOLLICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA ZYDIS</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>7.5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA ZYDIS</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugindication>DENTAL CARIES</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135718-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-ELI_LILLY_AND_COMPANY-CH201011006548</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135719-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011005224</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 1 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>021411</drugauthorizationnumb>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYVANSE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135720-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201011006986</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMATROPE</medicinalproduct>
        <drugauthorizationnumb>019640</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135721-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ELI_LILLY_AND_COMPANY-IT201011002319</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIC COMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>8 D/F, DAILY (1/D)</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100819</drugenddate>
        <drugtreatmentduration>2057</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMICRON</medicinalproduct>
        <drugdosagetext>30 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100820</drugenddate>
        <drugtreatmentduration>2058</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135722-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ELI_LILLY_AND_COMPANY-ES201011005443</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101105</drugenddate>
        <drugtreatmentduration>92</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADOLONTA</medicinalproduct>
        <drugdosagetext>UNK, EVERY 8 HRS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONADOXIN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPENVAS</medicinalproduct>
        <drugdosagetext>UNK, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERVONE</medicinalproduct>
        <drugdosagetext>UNK, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135724-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011006502</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>THROMBOSIS IN DEVICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugdosagetext>60 MG, LOADING DOSE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PERCUTANEOUS CORONARY INTERVENTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INTEGRILIN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135726-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011002140</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DROOLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA RELPREVV</medicinalproduct>
        <drugauthorizationnumb>022173</drugauthorizationnumb>
        <drugdosagetext>405 MG, MONTHLY (1/M)</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135727-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-ELI_LILLY_AND_COMPANY-AT201011005790</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugdosagetext>60 MG, OTHER (ONCE AS LOADING DOSE)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IN-STENT ARTERIAL RESTENOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135728-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-ELI_LILLY_AND_COMPANY-GR201011003014</companynumb>
    <primarysource>
      <reportercountry>GREECE</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>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGIOPLASTY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135729-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201010005375</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>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRASUGREL HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100529</drugstartdate>
      </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>ATIVAN</medicinalproduct>
        <drugdosagetext>1.5 MG, 3/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>500 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>125 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAXSEED OIL</medicinalproduct>
        <drugdosagetext>1 OTHER, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugdosagetext>500 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugdosagetext>1 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugdosagetext>0.4 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugdosagetext>135 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135730-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ELI_LILLY_AND_COMPANY-BR201010002158</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRASUGREL HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090926</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINVASTATINA</medicinalproduct>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAHISTINE</medicinalproduct>
        <drugindication>LABYRINTHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUSTRATE</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINA</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOGARD</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135731-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE201011000127</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>
      <reaction>
        <reactionmeddrapt>KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>A691860A</drugbatchnumb>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>29.2 U, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135732-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201006007307</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>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugdosagetext>35 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100916</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135733-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201001004269</companynumb>
    <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>SPINAL LAMINECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A551500C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMIDONE</medicinalproduct>
        <drugindication>TREMOR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANALGESICS</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135734-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201003006114</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>500 MG/M2, DAY 1 EVERY 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100218</drugenddate>
        <drugtreatmentduration>64</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>500 MG/M2, DAY 1 EVERY 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100311</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>6 AUC, DAY 1 EVERY 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100218</drugenddate>
        <drugtreatmentduration>64</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>15 MG/KG, DAY 1 EVERY 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100218</drugenddate>
        <drugtreatmentduration>64</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>15 MG/KG, DAY 1 EVERY 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100311</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>600 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091023</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>1000 UG, 9 WKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100326</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
        <drugdosagetext>800 MG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>1000 MG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091023</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091023</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugdosagetext>10 MG, AS NEEDED</drugdosagetext>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugdosagetext>6 MG, UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091218</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugdosagetext>150 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLOW-MAG</medicinalproduct>
        <drugdosagetext>UNK, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOMAGNESAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>4 MG/KG, 2/D</drugdosagetext>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091216</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135735-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13549BP</companynumb>
    <primarysource>
      <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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135736-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2010154434</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135737-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010157248</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>150 MG/DAY, FREQUENCY UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100829</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>300 MG/DAY, FREQUENCY UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100926</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>350 MG/DAY, FREQUENCY UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101011</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>400 MG/DAY, FREQUENCY UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101122</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugdosagetext>40 MG/DAY, FREQUENCY UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>2 MG/DAY, FREQUENCY UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100419</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135738-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2010154242</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135739-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-PFIZER INC-2010162814</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugauthorizationnumb>018972</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>25 MG, 1X/DAY</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>25 MG, 2X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACENOCOUMAROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135740-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU432636</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>NPLATE</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>180 MG, UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100223</drugenddate>
        <drugtreatmentduration>58</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135741-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-GILEAD-2010-0033789</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RALTEGRAVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFAMPIN</medicinalproduct>
        <drugindication>TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugindication>TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTRIMOXAZOLE</medicinalproduct>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101003</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135742-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-10P-087-0687771-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>48.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HILAR LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>4 MG/W</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>2 MG/W</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100409</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugdosagetext>400 MG DAILY</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRIDAMOLE</medicinalproduct>
        <drugdosagetext>200 MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL</medicinalproduct>
        <drugdosagetext>4 MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugdosagetext>5 MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugdosagetext>10 MG DAILY</drugdosagetext>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091212</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135743-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0620391-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019304</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010606</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019304</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010331</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135744-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-10P-087-0668660-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENTERITIS INFECTIOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100813</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>8 MG/W</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091030</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN SODIUM</medicinalproduct>
        <drugdosagetext>180 MG DAILY</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBAMIPIDE</medicinalproduct>
        <drugdosagetext>300 MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHINESE HERBAL MEDICINE</medicinalproduct>
        <drugdosagetext>7.5 GM DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
        <drugdosagetext>0.25 MCG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135745-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0620386-00</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021203</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060329</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021203</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060922</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135746-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0628178-00</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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</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>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>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <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>20090801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135747-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-10P-062-0688897-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN SALVES</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135748-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-09P-087-0616584-00</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>46.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFZON</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050739</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CYSTITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLORIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAYCARON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT CC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091225</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDENALIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091008</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135749-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0638892-00</companynumb>
    <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>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</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>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135750-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010157313</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>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugdosagetext>4 MG/WEEK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugauthorizationnumb>009987</drugauthorizationnumb>
        <drugdosagetext>2.5 MG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugdosagetext>200 MG PER PORTION</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135751-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RU-PFIZER INC-2010158090</companynumb>
    <primarysource>
      <reportercountry>RUSSIAN FEDERATION</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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
        <drugdosagetext>1 DROP INTO EACH EYE BEFORE NIGHT</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</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>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIOFOR</medicinalproduct>
        <drugdosagetext>500 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOLOL</medicinalproduct>
        <drugdosagetext>1 DROP INTO EACH EYE IN THE MORNING AND IN THE EVENING</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135752-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010157409</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>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE PROLAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugindication>SCOLIOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135753-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-PFIZER INC-2010157729</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</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>ELECTROCARDIOGRAM T WAVE INVERSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>021156</drugauthorizationnumb>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135754-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR201011006888</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAHOR</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERSYL</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDENSIEL</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARDEGIC</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135755-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GENENTECH-305339</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IDIOPATHIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>975 MG, Q28D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100730</drugenddate>
        <drugtreatmentduration>39</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENDAMUSTINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>135 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100730</drugenddate>
        <drugtreatmentduration>39</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100730</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135756-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060406</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GENENTECH-310628</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION RATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135757-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-GILEAD-2010-0031760</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATRIPLA</medicinalproduct>
        <drugauthorizationnumb>021937</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100827</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFATER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LYMPH NODE TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100817</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFINAH</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LYMPH NODE TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BESIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LYMPH NODE TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>NEPHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFAMPICIN</medicinalproduct>
        <drugindication>LYMPH NODE TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugindication>LYMPH NODE TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRAZINAMIDE</medicinalproduct>
        <drugindication>LYMPH NODE TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100126</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135758-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-PFIZER INC-2010158486</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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100204</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135759-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2010135134</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugdosagetext>300 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135760-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2010086339</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>HYPERAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SARCOIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>25 MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100607</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>25 MG, 2 CAPSULES A DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100609</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KARDEGIC</medicinalproduct>
        <drugdosagetext>300 MG A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100609</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALACYCLOVIR HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135761-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0673880-00</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>ARTERIOVENOUS FISTULA ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOVENOUS FISTULA THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOTONIC DYSTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>EVERY 4 HOURS AS NEEDED</drugdosagetext>
        <drugindication>NECK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugdosagetext>PATCHES</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
        <drugindication>RENAL FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>HEART RATE IRREGULAR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>GOUT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIZANIDINE</medicinalproduct>
        <drugindication>MUSCLE RELAXANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135762-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0685055-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</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>FENOFIBRATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <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>LEVOTHYROXINE SODIUM</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>7135763-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0685394-00</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>TONSIL CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135764-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0672069-00</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</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>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100412</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR 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>AVODART</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135765-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-10P-056-0686529-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOSOGNOSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APRAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMISENSORY NEGLECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED SELF-CARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135766-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-ABBOTT-10P-153-0687784-00</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>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>40 MG/0.8 ML</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135767-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0639381-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>16.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNICEF</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050749</drugauthorizationnumb>
        <drugdosagetext>14MG PER KILOGRAM, 231MG, ONCE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EAR INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100326</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135768-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0686346-00</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>
      <patientweight>93.07</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</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>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugbatchnumb>167542</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugbatchnumb>167542</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COGENTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135769-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GENENTECH-310588</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135770-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010131394</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>
      <patientweight>47</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>25 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100413</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BROTIZOLAM</medicinalproduct>
        <drugdosagetext>0.25 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100430</drugenddate>
        <drugtreatmentduration>37</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BROTIZOLAM</medicinalproduct>
        <drugindication>INSOMNIA RELATED TO ANOTHER MENTAL CONDITION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>1 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA RELATED TO ANOTHER MENTAL CONDITION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100414</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUAZEPAM</medicinalproduct>
        <drugdosagetext>15 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA RELATED TO ANOTHER MENTAL CONDITION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100419</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>1.25 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DECREASED APPETITE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100413</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM POLYSTYRENE SULFONATE</medicinalproduct>
        <drugdosagetext>25 G, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERKALAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>1.25 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>2.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>15 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
        <drugdosagetext>500 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135771-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2010159270</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>COLITIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHRONADALATE</medicinalproduct>
        <drugdosagetext>30 MG, 1X/DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMICRON</medicinalproduct>
        <drugdosagetext>30 MG, 1X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOBRADEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135772-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010123230</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100925</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135773-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-10P-062-0688549-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021906</drugauthorizationnumb>
        <drugdosagetext>1000 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101028</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135774-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0641189-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>16.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFDINIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050749</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EAR INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100326</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135775-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-GENENTECH-306219</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091015</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORETIC 100</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRONE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</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>PARACETAMOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091015</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135776-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-GILEAD-2010-0033793</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugauthorizationnumb>021356</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENTECAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090311</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135777-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GENENTECH-306069</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>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENE MUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOCHROMATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON OVERLOAD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSFERRIN SATURATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>2000 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1 G, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100630</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MTX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>15 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100705</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100710</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135778-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006623</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MESENTERIC VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STREPTOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101021</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135779-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2010141372</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEEDLE ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT EXPIRATION DATE ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RELISTOR</medicinalproduct>
        <drugauthorizationnumb>021964</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135780-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-PFIZER INC-2010145252</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>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTATIC RENAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TORISEL</medicinalproduct>
        <drugauthorizationnumb>022088</drugauthorizationnumb>
        <drugdosagetext>25 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101011</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135781-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161662</companynumb>
    <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>SENSATION OF PRESSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE FLOW DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOVIAZ</medicinalproduct>
        <drugauthorizationnumb>022030</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135782-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010162941</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135783-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2010156534</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GROWTH RETARDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL ANOXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>125 MG DAILY</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135784-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080317</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GENENTECH-310591</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>INFLAMMATORY MARKER INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135785-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-ABBOTT-10P-082-0689068-00</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</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>COMPLICATION OF PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REDUCTIL 15MG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020632</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBESITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135786-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0687567-00</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>DIVERTICULUM INTESTINAL HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE WOUND INFECTION</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>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTIVA</medicinalproduct>
        <drugindication>GASTROINTESTINAL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMUCIL TYPE MEDICATION</medicinalproduct>
        <drugindication>ABNORMAL FAECES</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135787-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-09P-163-0559665-00</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>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTOID MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</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>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <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>ACTINOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>Q DAY</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMOCRIPTINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR 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</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BONE DENSITY TABLET</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135788-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010157099</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOTION SICKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>020151</drugauthorizationnumb>
        <drugdosagetext>37.5 PILLS EVERY 36 HOURS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135789-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-PFIZER INC-2010157513</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCHIZOPHRENIA, CATATONIC TYPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF-INJURIOUS IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>020151</drugauthorizationnumb>
        <drugdosagetext>225 MG, 1X/DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090625</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>020151</drugauthorizationnumb>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100914</drugenddate>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135790-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010157272</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>50 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>25 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135791-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-1011USA01301</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>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYSLEE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAUZELIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135792-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-1011USA03465</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101003</drugenddate>
        <drugtreatmentduration>222</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPIDIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIVADIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135793-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0907USA00159</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>BREAST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISLOCATION OF VERTEBRA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SPRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LICHEN PLANUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGAMENT SPRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE STRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIODONTAL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIODONTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYCYTHAEMIA VERA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRIGEMINAL NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
        <drugtreatmentduration>1643</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135794-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1011USA03394</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>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135795-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-1011FRA00097</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>ACUTE CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOTOR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOROXIN</medicinalproduct>
        <drugauthorizationnumb>019384</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CYSTITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERINDOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100829</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN LYSINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100829</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135796-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1007USA01976</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE BREAKAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESSENTIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOITRE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SPRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBMANDIBULAR MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070716</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070716</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM CD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRODIURIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000210</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135797-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-1011USA01300</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>ALVEOLITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUVASTATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135798-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0803USA04671</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>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPOD STING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION SUICIDAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPULIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL RECESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRIGEMINAL NERVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050729</drugenddate>
        <drugtreatmentduration>236</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135799-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-MERCK-1011USA03408</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETIC HYPERGLYCAEMIC COMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMEND</medicinalproduct>
        <drugauthorizationnumb>021549</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMEND</medicinalproduct>
        <drugauthorizationnumb>021549</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMEND</medicinalproduct>
        <drugauthorizationnumb>021549</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEMETIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135800-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-1012DEU00009</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugauthorizationnumb>017555</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135801-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0911USA04329</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>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLLAGEN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOOSE TOOTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL TORUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIODONTAL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135802-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1006USA01817</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>87</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTINIC KERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADRENAL INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA OF CHRONIC DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA POSTOPERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARBUNCLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICAL SPINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED IMMUNE RESPONSIVENESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSTHYMIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESSENTIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMALE GENITAL TRACT FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FURUNCLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOITRE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR SPINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENISCUS LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE DISEASE MIXED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIXED HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYMYALGIA RHEUMATICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL TEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION STAPHYLOCOCCAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080601</drugenddate>
        <drugtreatmentduration>1989</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080601</drugenddate>
        <drugtreatmentduration>1989</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTACID LIQUID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLTX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ROUTINE HEALTH MAINTENANCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135803-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0907USA00902</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>71</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACARODERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY HEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAILURE TO THRIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANDIOSITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACUNAR INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASTICATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESSURE OF SPEECH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBCUTANEOUS ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081001</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080417</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090914</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135804-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-1010USA02797</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>
      <patientweight>55</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GRANULOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAUZELIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLITOSE (AMYLASE (+) CELLULASE (+) LIPASE (+) PANCREATIN (+) PROTEASE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101013</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135805-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0805USA05502</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA MACROCYTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL SKIN INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUMERUS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTONIC BLADDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPLANT SITE ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOCUTANEOUS CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CAVITY FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REGURGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEBORRHOEIC DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC CANDIDA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135806-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1007USA03940</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>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COR PULMONALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA ALZHEIMER'S TYPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION VENTRICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODAL ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTPERICARDIOTOMY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIGHT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN B12 DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugauthorizationnumb>021762</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080818</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050901</drugenddate>
        <drugtreatmentduration>47</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001001</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135807-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-ELI_LILLY_AND_COMPANY-ZA201012000364</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>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG MIX 75/25</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101114</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135808-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201009002876</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR GRAFT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A709633D</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A723778C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEO-DUR</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISORBIDE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPRAL</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPID</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>GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SINUS DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL WITH CODEIN #4</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135809-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-ELI_LILLY_AND_COMPANY-NO201011004950</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MECHANICAL VENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135810-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201001004269</companynumb>
    <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>SPINAL LAMINECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A551500C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMIDONE</medicinalproduct>
        <drugindication>TREMOR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANALGESICS</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135811-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201010000879</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 INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>120 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135812-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011005097</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>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEG AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TERMINAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135813-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011004839</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>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugtreatmentduration>335</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTHROTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UROXATRAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135814-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201007002062</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 OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A709633D</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A713108C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugtreatmentduration>122</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUONEB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM +VIT D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOLAZONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CATAPRES /00171102/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135815-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201008008805</companynumb>
    <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>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOLLICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA ZYDIS</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>7.5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA ZYDIS</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugindication>DENTAL CARIES</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135816-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GENENTECH-285830</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>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>375 MG/M2, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>WEGENER'S GRANULOMATOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135817-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-AMGEN-QUU436243</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>6 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100816</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100812</drugenddate>
        <drugtreatmentduration>121</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100812</drugenddate>
        <drugtreatmentduration>121</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED ANTINEOPLASTIC AGENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135818-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-KDC438006</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DERMATITIS ACNEIFORM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARONYCHIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANITUMUMAB</medicinalproduct>
        <drugdosagetext>480 MG, Q2WK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100831</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100817</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100817</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100817</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100817</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100817</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM LEVOFOLINATE</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100817</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM LEVOFOLINATE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100817</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOXI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMEND</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONIEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LONGES</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIO THREE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135819-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AMGEN-US393917</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR VERTEBRAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOCLONAL GAMMOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLASMACYTOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PUSTULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPERINFECTION BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THORACIC VERTEBRAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNDERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100117</drugenddate>
        <drugtreatmentduration>207</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100131</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECORTIN-H                         /00016201/</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METEX                              /00113802/</medicinalproduct>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLSAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135820-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-GENENTECH-308588</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>42</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>1072.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>1012 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugdosagetext>71.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugdosagetext>67.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugdosagetext>6 MG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugdosagetext>6 MG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135821-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2010157582</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85</patientweight>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>150 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GENERALISED ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SITAGLIPTIN</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135822-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2010157518</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING DRUNK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG DAILY</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>25 MG, 1X/DAY (IN THE EVENING)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135823-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2009308783</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>136.96</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPATIENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFERTILITY FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOCIAL FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugdosagetext>40 MG, 2X/DAY, EVERY 12 HOURS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugdosagetext>120MG (1 CAPSULE OF 40 MG PLUS 1 CAPSULE OF 80 MG AT NIGHT), DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugdosagetext>80 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPROMAZINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEULEPTIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOZINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135824-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010092578</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROUP INFECTIOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYPTORCHISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAILURE TO THRIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART DISEASE CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATENT DUCTUS ARTERIOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREPUCE REDUNDANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135825-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2010157698</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST ENLARGEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MENSTRUAL CYCLE MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DORIXINA RELAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135826-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010092589</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIAL HYPERREACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BULIMIA NERVOSA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVELOPMENTAL DELAY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAILURE TO THRIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART DISEASE CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPLASTIC LEFT HEART SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOTOR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS MEDIA ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY MUSCLE WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>HALF TABLET ONCE DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135827-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CZ-GENENTECH-309230</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>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>500 MG/M2, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100802</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>150 MG/M2, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101004</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARA</medicinalproduct>
        <drugdosagetext>12 MG/M2, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101004</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100906</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135828-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-310646</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>MYOCARDIAL RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTIVASE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ISCHAEMIC STROKE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135829-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GENENTECH-310329</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1000 MG, Q6M</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100804</drugenddate>
        <drugtreatmentduration>226</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVATREX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100819</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTARENE (FRANCE)</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>DRUG REPORTED AS VOLTARENE 75</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPECIAFOLDINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ PROPOXYPHENE HCL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOMIL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135830-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070913</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GENENTECH-310589</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135831-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-PFIZER INC-2010159139</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>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EUPHORIC MOOD</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>75 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugtreatmentduration>61</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>150 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
        <drugtreatmentduration>244</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135832-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007337064</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATED DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEXUAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOCIAL PHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugauthorizationnumb>020151</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020820</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CODEINE</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020820</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOFEPRAMINE</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUROFEN</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020820</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT ^SMITH KLINE BEECHAM^</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHAMPHETAMINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COCAINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHANOL</medicinalproduct>
        <drugdosagetext>2 CANS OF LAGER</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135833-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010096523</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>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</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>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135834-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-10P-056-0654575-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MAJOR DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019304</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM OXALATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM OXALATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM OXALATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100720</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORSET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORSET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERALITHE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERESTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LARGACTIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135835-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-ABBOTT-10P-082-0677799-00</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REDUCTIL 15MG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020632</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBESITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REDUCTIL 15MG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020632</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135836-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-09P-163-0559665-00</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>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTOID MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</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>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <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>ACTINOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>Q DAY</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMOCRIPTINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR 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</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BONE DENSITY TABLET</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135837-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-ABBOTT-10P-143-0620788-00</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>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</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>20091101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULPHASALAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135838-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>LB-GENENTECH-309632</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>500 MG, 1/WEEK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135839-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010099313</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>54</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA BACTERIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUNITINIB MALATE</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>25 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090625</drugenddate>
        <drugtreatmentduration>84</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYSENNID</medicinalproduct>
        <drugdosagetext>2 DF, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVAMIN</medicinalproduct>
        <drugdosagetext>5 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>60 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>5 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYSLEE</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugdosagetext>5 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugdosagetext>1 DF, 3X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
        <drugdosagetext>5 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MERCAZOLE</medicinalproduct>
        <drugdosagetext>5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUTROGIN</medicinalproduct>
        <drugdosagetext>100 UG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090429</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135840-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2010159294</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>150 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101004</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>150 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101014</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAROXYL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101006</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135841-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MY-PFIZER INC-2010123338</companynumb>
    <primarysource>
      <reportercountry>MALAYSIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>200 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugdosagetext>80 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135842-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PFIZER INC-2010113389</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL DRYNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>1 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135843-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2010118035</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>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOBACCO USER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugdosagetext>1 AND A HALF TABLET, ALTERNATE DAYS</drugdosagetext>
        <drugindication>CARDIOVASCULAR EVENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETIMIBE</medicinalproduct>
        <drugdosagetext>5 MG, 1X/DAY, IN THE MORNING</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>NERVOUSNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURAN T4</medicinalproduct>
        <drugdosagetext>100 UG, UNK</drugdosagetext>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURAN T4</medicinalproduct>
        <drugindication>HYPERTHYROIDISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135844-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-GENENTECH-310217</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>375 MG/M2, 1/WEEK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GRAFT VERSUS HOST DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>375 MG/M2, 1/MONTH</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GRAFT VERSUS HOST DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>750 MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GRAFT VERSUS HOST DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135845-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-GENENTECH-310223</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EMBOLISM ARTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>600 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXORUBICIN</medicinalproduct>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135846-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006751</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugbatchnumb>1022199</drugbatchnumb>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>80 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135847-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20100700273</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMPONI</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
        <drugindication>LOCALISED INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135848-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-JNJFOC-20101109103</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VULVAL NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GOLIMUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135849-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20100908562</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GOLIMUMAB</medicinalproduct>
        <drugbatchnumb>3190</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135850-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101109015</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADRENAL INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GOLIMUMAB</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GOLIMUMAB</medicinalproduct>
        <drugauthorizationnumb>009925</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELCHOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135851-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010004935</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>NPLATE</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135852-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010005900</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>NPLATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135853-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AMGEN-QUU420541</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTI-PLATELET ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW MYELOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELOFIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>3 A?G/KG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100716</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN</medicinalproduct>
        <drugdosagetext>1 G, 2 TIMES/WK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100617</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135854-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU437088</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>113 A?G, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>UNK UNK, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100314</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>UNK UNK, QWK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100805</drugenddate>
        <drugtreatmentduration>149</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugbatchnumb>1018707</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugbatchnumb>1021475</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugbatchnumb>1021478</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE W/CHONDROITIN SULFATES</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>175 A?G, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>.25 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugdosagetext>2400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOCOPHEROL CONCENTRATE CAP</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135855-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010001877</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>APLASIA PURE RED CELL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW RETICULIN FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugdosagetext>40000 UNIT, QWK</drugdosagetext>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101013</drugenddate>
        <drugtreatmentduration>1329</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100922</drugenddate>
        <drugtreatmentduration>1277</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDAMUSTINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE W/VINCRISTINE/PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135856-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-10P-028-0685295-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</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>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>6002165</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090728</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>6002165</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>2.5MG, 7 TABLETS WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugdosagetext>35 MG WEEKLY</drugdosagetext>
        <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>PLAQUENIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>5MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONICOTINIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYCOBACTERIUM TUBERCULOSIS COMPLEX TEST POSITIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135857-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010001334</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL MYCOTIC INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL                          /00072601/</medicinalproduct>
        <drugdosagetext>200 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>|2.5 MG, Q6WK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEXOFENADINE HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>4 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULINDAC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTITHROMBOTIC AGENTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135858-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010005895</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNE GLOBULIN NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135859-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101120</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-GENZYME-CAMP-1001155</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAPILLARY LEAK SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOHISTIOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAMPATH</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>30 MG, 3X/W</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE PHOSPHATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135860-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101120</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-GENZYME-FLUD-1000448</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAPILLARY LEAK SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOHISTIOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020038</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEMTUZUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>30 MG, 3X/W</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA RECURRENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135861-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SP-2010-06808</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugindication>BLADDER CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135862-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-12914BP</companynumb>
    <primarysource>
      <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>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC 150</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021698</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101118</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135863-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101128</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010007073</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GASTRIC CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100806</drugenddate>
        <drugtreatmentduration>110</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135864-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006573</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPEUTICS NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135865-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010007156</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135886-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-000689</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GALLBLADDER INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135888-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101128</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-BAYER-2010-000126</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, UNK</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugtreatmentduration>1095</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135890-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042130NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135891-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-000973</companynumb>
    <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>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE + ETHINYLESTRADIOL 20A?G (24+4)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135892-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20081001</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042093NA</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>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASYLOL</medicinalproduct>
        <drugauthorizationnumb>020304</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SURGERY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19950801</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135893-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042104NA</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>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>FREQUENCY:CONTINUOUS</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135894-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042083NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081107</drugenddate>
        <drugtreatmentduration>140</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135896-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100826</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201034872NA</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>MULTIPLE INJURIES</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>YASMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135897-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100701</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201029020NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135899-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042144NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135900-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100831</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201028694NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.818</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020701</drugenddate>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugindication>MENSTRUAL CYCLE MANAGEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TPN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL ES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135903-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BAYER-2010-000559</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RENNIE SPEARMINT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101114</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEART MEDICATION (NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135904-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042142NA</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>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135905-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042007NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR OF DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE INJURIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASYLOL</medicinalproduct>
        <drugauthorizationnumb>020304</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135906-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-BAYER-201047848GPV</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SCROTAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100317</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEGALON</medicinalproduct>
        <drugdosagetext>DAILY DOSE 70 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOLOC</medicinalproduct>
        <drugdosagetext>DAILY DOSE 40 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UROSIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE 300 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPA MERZ / ORNITHINASPARTAT</medicinalproduct>
        <drugdosagetext>DAILY DOSE 9 G</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUROBION FORTE / THIAMIN DISULFID [NEUROBION (CYANOCOBALAMIN,PYRIDOXI</medicinalproduct>
        <drugdosagetext>DAILY DOSE 600 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugdosagetext>DAILY DOSE 4 PUFF(S)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE 300 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASILACTON</medicinalproduct>
        <drugdosagetext>20/50 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100402</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVALGIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE 60 GTT</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100402</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOTRIMAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100402</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAVANIC</medicinalproduct>
        <drugdosagetext>DAILY DOSE 500 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100415</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTRIAXON</medicinalproduct>
        <drugdosagetext>DAILY DOSE 6 G</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100409</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135907-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BAYER-201045936GPV</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>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTAVIS</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>AS USED DOSE: UNK</drugdosagetext>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081029</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135908-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>RU-BAYER-201035285GPV</companynumb>
    <primarysource>
      <reportercountry>RUSSIAN FEDERATION</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100717</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135909-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-000442</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>
      <reaction>
        <reactionmeddrapt>GALLBLADDER INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE INJURIES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135910-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201014072NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIARY ADENOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIARY COLIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREECH PRESENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER ENLARGEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER NON-FUNCTIONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
        <drugtreatmentduration>731</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
        <drugtreatmentduration>731</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNCODEABLE ^UNCLASSIFIABLE^</medicinalproduct>
        <drugdosagetext>SPORADICALLY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM [POTASSIUM]</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KINEVAC</medicinalproduct>
        <drugdosagetext>HEPATOBILIARY SCAN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTRIM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRETINOIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOESTRIN 1.5/30</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOESTRIN 1.5/30</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE ACETATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL AND ACETAMINOPHEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DRYSOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135911-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>JP-BAYER-201011609BYL</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>800 MG (DAILY DOSE), , ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090917</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>400 MG (DAILY DOSE), , ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091204</drugenddate>
        <drugtreatmentduration>79</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>200 MG (DAILY DOSE), , ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091217</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>400 MG (DAILY DOSE), , ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100312</drugenddate>
        <drugtreatmentduration>86</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>600 MG (DAILY DOSE), , ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100708</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugdosagetext>600 MG (DAILY DOSE), , ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVACT</medicinalproduct>
        <drugdosagetext>12.45 G (DAILY DOSE), , ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SHAKUYAKUKANZOUTOU</medicinalproduct>
        <drugdosagetext>7.5 G (DAILY DOSE), , ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugdosagetext>0.25 MG (DAILY DOSE), , ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAURINE</medicinalproduct>
        <drugdosagetext>3.06 G (DAILY DOSE), , ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091127</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135912-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-001007</companynumb>
    <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 INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135913-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BAYER-201047470GPV</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <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>7135914-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042141NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135915-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</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>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACARDIAC THROMBUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080505</drugenddate>
        <drugtreatmentduration>340</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080505</drugenddate>
        <drugtreatmentduration>340</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILK OF MAGNESIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135916-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042054NA</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>VIITH NERVE PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135917-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</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>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACARDIAC THROMBUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080505</drugenddate>
        <drugtreatmentduration>340</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080505</drugenddate>
        <drugtreatmentduration>340</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILK OF MAGNESIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135918-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-000457</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GALLBLADDER INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135919-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BAYER-2010-000743</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA MUCOSAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST 150</medicinalproduct>
        <drugauthorizationnumb>020220</drugauthorizationnumb>
        <drugdosagetext>150 ML, ONCE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101027</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135920-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201030075NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MULTIPLE INJURIES</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>YASMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135921-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042117NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135922-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201038186NA</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>MULTIPLE INJURIES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE + ETHINYLESTRADIOL 20A?G (24+4)</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135923-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201041946NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugbatchnumb>5401VWX</drugbatchnumb>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>400 MG AM; 200 MG PM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101026</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135924-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201041926NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101103</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135925-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100927</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BAYER-201040729GPV</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 PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST 370</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020220</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COMPUTERISED TOMOGRAM ABDOMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100818</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135926-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201038439NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL VARICES HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101026</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>2UNITS IN AM AND 2 UNITS AT NOON</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>5 UNITS IN PM</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFAXIMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL BACTERIAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135927-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201038315NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MULTIPLE INJURIES</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>YASMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135928-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>JP-BAYER-201012263BYL</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090821</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>400 MG (DAILY DOSE), , ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090911</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>200 MG (DAILY DOSE), , ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090911</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135929-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-000836</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>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135930-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042041NA</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>GALLBLADDER INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135931-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042143NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEVICE DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU006U3</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>FREQUENCY: CONTINUOUS</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101122</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135932-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201026700NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER CHOLESTEROLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
        <drugtreatmentduration>1461</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135933-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201019666NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135934-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>BE-BAYER-2010-000623</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</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 A?G, CONTINUOUS</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100913</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135936-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042071NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.727</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST 370</medicinalproduct>
        <drugauthorizationnumb>021425</drugauthorizationnumb>
        <drugdosagetext>RIGHT HAND USING WARMER AND POWER INJECTOR @ A RATE OF 2 CC /SECOND</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101122</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST 370</medicinalproduct>
        <drugauthorizationnumb>021425</drugauthorizationnumb>
        <drugdosagetext>ULTRAVIST GIVEN AS ORAL CONTRAST</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COMPUTERISED TOMOGRAM ABDOMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135937-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042051NA</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>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135938-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042098NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR OF DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE INJURIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASYLOL</medicinalproduct>
        <drugauthorizationnumb>020304</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135939-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-000592</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MULTIPLE INJURIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135940-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042091NA</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>YAZ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090326</drugenddate>
        <drugtreatmentduration>432</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135941-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042133NA</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>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135942-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100810</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200937696NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECONOMIC PROBLEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081001</drugenddate>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081001</drugenddate>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135943-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042131NA</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>YASMIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050201</drugenddate>
        <drugtreatmentduration>487</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135944-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042040NA</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>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135945-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201028658NA</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>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091101</drugenddate>
        <drugtreatmentduration>395</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090701</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090630</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135946-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100817</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201030814NA</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>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021085</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135947-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100630</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201028846NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MULTIPLE INJURIES</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>YASMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135949-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201037998NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <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>YASMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135950-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042123NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY WITH CONTRACEPTIVE DEVICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>FREQUENCY: CONTINUOS</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135952-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042073NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090924</drugenddate>
        <drugtreatmentduration>607</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135954-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100803</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201013589NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>SAMPLES RECEIVED IN 2000-2006. - AS USED DOSE: UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080201</drugenddate>
        <drugtreatmentduration>1552</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>DAILY DOSE 20 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>DAILY DOSE 300 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>DAILY DOSE 200 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugdosagetext>DAILY DOSE 20 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080701</drugenddate>
        <drugtreatmentduration>152</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135955-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-000444</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>
      <reaction>
        <reactionmeddrapt>ERUCTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HICCUPS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugbatchnumb>215990K</drugbatchnumb>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>440 MG, BID</drugdosagetext>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE [CALCIUM,VITAMIN D NOS]</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135956-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-BAYER-2010-001023</companynumb>
    <primarysource>
      <reportercountry>TURKEY</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>MINOSET PLUS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101126</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135957-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-BAYER-2010-000148</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE 100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090303</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLORIC</medicinalproduct>
        <drugdosagetext>DAILY DOSE 100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>DAILY DOSE 10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCOR PLUS</medicinalproduct>
        <drugdosagetext>DAILY DOSE 1 DF</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135958-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201041612NA</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>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>021085</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101112</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135959-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BAYER-201041667NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANTEPARTUM HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIGH RISK PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY ON ORAL CONTRACEPTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135960-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201041812NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>COMPLICATION OF DEVICE REMOVAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXPIRED DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONTRACEPTIVES NOS</medicinalproduct>
        <drugindication>UTERINE CERVIX DILATION PROCEDURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNCODEABLE ^UNCLASSIFIABLE^</medicinalproduct>
        <drugindication>UTERINE CERVIX DILATION PROCEDURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135961-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201016882NA</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>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugdosagetext>20 PLUS YEARS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSAID'S</medicinalproduct>
        <drugdosagetext>20 PLUS YEARS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugdosagetext>0.75%</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135962-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201038145NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <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>YASMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135963-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201030011NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MULTIPLE INJURIES</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>YASMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135967-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-BAYER-2010-000178</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</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>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>021085</drugauthorizationnumb>
        <drugdosagetext>400 MG, 2 TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135968-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-BAYER-2010-000255</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN SODIUM HIGH DOSE (} 220 MG)</medicinalproduct>
        <drugdosagetext>750 MGD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101016</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DYGRATYL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOPARATHYROIDISM</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135969-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>BE-BAYER-2010-000670</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>COMPLICATION OF DEVICE INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE PERFORATION</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>20100503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100503</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135970-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201023571BCC</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>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONE A DAY ENERGY</medicinalproduct>
        <drugbatchnumb>52586</drugbatchnumb>
        <drugdosagetext>DAILY DOSE 1 DF</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101030</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135971-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-BAYER-201034947GPV</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>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTAVIA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTAVIA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTAVIA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVENTIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNCODEABLE ^UNCLASSIFIABLE^</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVINZA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN ES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135972-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201033324NA</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>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081101</drugenddate>
        <drugtreatmentduration>1187</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>CENTRUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135973-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-000832</companynumb>
    <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 INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE INJURIES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135974-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042085NA</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>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135975-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BAYER-2010-000290</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QLAIRA</medicinalproduct>
        <drugauthorizationnumb>022252</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135976-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201038878NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135978-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042048NA</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>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135980-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-000620</companynumb>
    <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>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135981-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-000698</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GALLBLADDER INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135983-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201038177NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MULTIPLE INJURIES</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>YASMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135984-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042011NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR OF DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE INJURIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASYLOL</medicinalproduct>
        <drugauthorizationnumb>020304</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135985-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042008NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR OF DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE INJURIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASYLOL</medicinalproduct>
        <drugauthorizationnumb>020304</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135986-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042132NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135987-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201041855NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEVICE DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>FREQUENCY CONTINUOUS</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135988-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042121NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY WITH CONTRACEPTIVE DEVICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU0021C</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>FREQUENCY: CONTINUOUS</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135989-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100810</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200937696NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>100</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECONOMIC PROBLEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081001</drugenddate>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081001</drugenddate>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135990-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BAYER-201047756GPV</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OEDEMA MUCOSAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST 370</medicinalproduct>
        <drugauthorizationnumb>020220</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101105</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135991-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BAYER-2010-000498</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMINAX EXPRESS</medicinalproduct>
        <drugdosagetext>9.6 TO 16 G</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135992-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201041805NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>AMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAROSMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY WITH CONTRACEPTIVE DEVICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 A?G (DAILY DOSE), , INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100611</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135993-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201030037NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MULTIPLE INJURIES</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>YASMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135994-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042149NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CERVIX DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugadministrationroute>015</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135997-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100826</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201034817NA</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>MULTIPLE INJURIES</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>YASMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135998-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BAYER-201045118GPV</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ASPHYXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST 370</medicinalproduct>
        <drugbatchnumb>03810C</drugbatchnumb>
        <drugauthorizationnumb>020220</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101102</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7135999-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-000848</companynumb>
    <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 INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136001-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAYER-201015874BYL</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>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101012</drugenddate>
        <drugtreatmentduration>54</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136002-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-BAYER-201043400GPV</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</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>EXTAVIA</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100825</drugenddate>
        <drugtreatmentduration>38</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136003-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042129NA</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>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE LEIOMYOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE LEIOMYOSARCOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050501</drugenddate>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136004-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>FR-BAYER-2010-000700</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IOPROMIDE</medicinalproduct>
        <drugauthorizationnumb>020220</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136005-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042095NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080926</drugenddate>
        <drugtreatmentduration>86</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136006-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100810</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200937696NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECONOMIC PROBLEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED INTRAABDOMINAL FLUID COLLECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE INJURIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081001</drugenddate>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081001</drugenddate>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136007-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BAYER-2010-000288</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>APLASTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMOCHROMIC NORMOCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON BETA-1B</medicinalproduct>
        <drugdosagetext>DAILY DOSE 1 ML</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136008-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BAYER-201047935GPV</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENDOPROST</medicinalproduct>
        <drugbatchnumb>93042B</drugbatchnumb>
        <drugindication>SYSTEMIC SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136009-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-000685</companynumb>
    <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 INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136010-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201037952NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>102.27</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>PFS: 2006, MEDICAL RECORDS: 2005.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE</medicinalproduct>
        <drugdosagetext>PHARMACY RECORDS: DISPENSED IN JUL 2005 , FEB 2008, JUL 2009 AND MAY 2010;</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIVORA-21</medicinalproduct>
        <drugdosagetext>PHARMACY RECORDS: NOV 2008</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136011-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100630</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201028841NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MULTIPLE INJURIES</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>YASMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136012-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CY-BAYER-201047920GPV</companynumb>
    <primarysource>
      <reportercountry>CYPRUS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST 370</medicinalproduct>
        <drugbatchnumb>0181C</drugbatchnumb>
        <drugauthorizationnumb>020220</drugauthorizationnumb>
        <drugdosagetext>70 ML, ONCE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101122</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136013-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042139NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136014-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-001017</companynumb>
    <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 INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136015-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200921945NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID RETRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HORNER'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT HYPEREXTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE WITH AURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>CONTINUOUS</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090306</drugenddate>
        <drugtreatmentduration>110</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM PERFORMANCE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINERAL TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136016-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>ES-BAYER-201046724GPV</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARINA</medicinalproduct>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136017-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-000443</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE + ETHINYLESTRADIOL 20A?G (24+4)</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090227</drugenddate>
        <drugtreatmentduration>198</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136018-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201034037GPV</companynumb>
    <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>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTAVIS</medicinalproduct>
        <drugbatchnumb>94502A</drugbatchnumb>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>FIRST AND LAST SHIPMENT ON 16-JUN-2010 - I-NEB AAD SYSTEM AND I-NEB CHAMBER PURPLE</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>EP067P0101</drugbatchnumb>
        <drugdosagetext>FIRST SHIPMENT ON 02-NOV-2009 AND LAST SHIPMENT ON 16-JUN-2010</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>EP072PO102</drugbatchnumb>
        <drugdosagetext>FIRST SHIPMENT ON 02-NOV-2009 AND LAST SHIPMENT ON 02-NOV-2010</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TADALAFIL</medicinalproduct>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CHANNEL BLOCKERS</medicinalproduct>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136019-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042023NA</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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>021085</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136020-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201026388NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE EXPULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY WITH CONTRACEPTIVE DEVICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>FREQUENCY: CONTINUOUS</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080918</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136021-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100423</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200939451NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENE MUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCOAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN C DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN S INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS MESENTERIC VESSEL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136022-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101013</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201022689BCC</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>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>2 DF, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101013</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136023-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100701</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201027021NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136024-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201038174NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MULTIPLE INJURIES</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>YASMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136025-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100816</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201033954NA</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>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136027-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201047886GPV</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>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA VIRAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTAVIS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>FIRST SHIPMENT: 14-AUG-2009 / LAST SHIPMENT: 13-AUG-2010; I-NEB CHAMBER GOLD; I-NEB AAD SYSTEM</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>DP026P0102</drugbatchnumb>
        <drugdosagetext>FIRST AND LAST SHIPMENT DATES: 18-OCT-2010</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101026</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CHANNEL BLOCKERS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136028-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201041141NA</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>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>YASMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136029-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-001013</companynumb>
    <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 INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136030-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-000451</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GALLBLADDER INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136031-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201022560BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>13.636</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>213080H</drugbatchnumb>
        <drugdosagetext>3 DF, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136032-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042050NA</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>YAZ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136034-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201041976NA</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>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>021085</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136035-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201041711NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>021085</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101113</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIAC</medicinalproduct>
        <drugindication>BLOOD PRESSURE ABNORMAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136036-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042105NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090127</drugenddate>
        <drugtreatmentduration>267</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136037-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100820</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200942654NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugbatchnumb>51203A</drugbatchnumb>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080306</drugenddate>
        <drugtreatmentduration>1706</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugdosagetext>PHARMACY RECORDS: FILLED ON FEB-2003 AND APR-2003</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>PHARMACY RECORDS: FILLED IN FEB-2003</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LINDANE</medicinalproduct>
        <drugdosagetext>1 %, PHARMACY RECORDS: FILLED ON 28-APR-2004</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136038-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090528</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042030NA</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>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE INJURIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASYLOL</medicinalproduct>
        <drugauthorizationnumb>020304</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136039-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201029827NA</companynumb>
    <primarysource>
      <reportercountry>AZERBAIJAN</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE INJURIES</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>YASMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136040-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BAYER-2010-000026</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE WITH AURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101115</drugenddate>
        <drugtreatmentduration>96</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136041-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042119NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136042-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-BAYER-201047929GPV</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTAVIA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136043-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042029NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136044-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-000605</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136045-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201026823NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL ADHESIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIARY COLIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060801</drugenddate>
        <drugtreatmentduration>517</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060801</drugenddate>
        <drugtreatmentduration>517</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136046-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201024463NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.091</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY WITH CONTRACEPTIVE DEVICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>72264B</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>FREQUENCY: CONTINUOUS</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100528</drugenddate>
        <drugtreatmentduration>864</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136048-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201016271NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER CHOLESTEROLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE STRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>83514A</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090901</drugenddate>
        <drugtreatmentduration>578</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136049-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>ES-BAYER-2010-000103</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST 150</medicinalproduct>
        <drugbatchnumb>03822A</drugbatchnumb>
        <drugauthorizationnumb>020220</drugauthorizationnumb>
        <drugdosagetext>120 ML, ONCE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101122</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST 150</medicinalproduct>
        <drugauthorizationnumb>020220</drugauthorizationnumb>
        <drugindication>COMPUTERISED TOMOGRAM THORAX</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136050-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201021758NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLICATED MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA FACIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIITH NERVE PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>AS USED DOSE: UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090401</drugenddate>
        <drugtreatmentduration>2192</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>AS USED DOSE: UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090401</drugenddate>
        <drugtreatmentduration>2192</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
        <drugtreatmentduration>1096</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
        <drugindication>VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
        <drugindication>VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090430</drugenddate>
        <drugtreatmentduration>731</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
        <drugtreatmentduration>1826</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090219</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPANA ER NOS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090430</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXCONDONE HCL NOS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARISOPRODOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROXICET</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090430</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090430</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090430</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136053-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201030389NA</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>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYZAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080807</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPYLTHIOURACIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080807</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENTYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136055-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042038NA</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>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136056-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042107NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>021085</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136058-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-000896</companynumb>
    <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>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136059-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100505</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201011442NA</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>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>54755C</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>FREQUENCY: CONTINUOUS</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090501</drugenddate>
        <drugtreatmentduration>713</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136060-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-000699</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GALLBLADDER INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136061-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-BAYER-2010-000054</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>021085</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101124</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136062-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-000305</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE + ETHINYLESTRADIOL 20A?G (24+4)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136063-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BAYER-201047916GPV</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRIGEMINAL NEURALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTAVIA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090510</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136064-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BAYER-2010-000133</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugbatchnumb>349530</drugbatchnumb>
        <drugauthorizationnumb>021085</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SINOBRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101126</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136065-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201038284NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MULTIPLE INJURIES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136066-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042137NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>61</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030901</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>61</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030901</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136067-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201023356BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.091</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugbatchnumb>215230J</drugbatchnumb>
        <drugdosagetext>220 MG, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYL SALICYLIC ACID USP BAT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136069-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100826</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201034820NA</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>MULTIPLE INJURIES</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>YASMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136070-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAYER-201015865BYL</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100206</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100215</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136071-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201035505NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101029</drugenddate>
        <drugtreatmentduration>58</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136072-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201022040NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>111.36</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST 300</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020220</drugauthorizationnumb>
        <drugdosagetext>1ML/SEC INTO UNSPECIFIED SITE, WARMER AND POWER INJECTOR</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100422</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST 300</medicinalproduct>
        <drugbatchnumb>94768K</drugbatchnumb>
        <drugauthorizationnumb>020220</drugauthorizationnumb>
        <drugdosagetext>1.0 ML/SEC INTO LEFT ANTECUBITAL USING POWER INJECTOR</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COMPUTERISED TOMOGRAM ABDOMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST 300</medicinalproduct>
        <drugbatchnumb>01770D</drugbatchnumb>
        <drugauthorizationnumb>020220</drugauthorizationnumb>
        <drugdosagetext>0.8ML/SEC INTO LEFT ANTECUBITAL, POWER INJECTOR AND WARMER</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST 300</medicinalproduct>
        <drugbatchnumb>01770D</drugbatchnumb>
        <drugauthorizationnumb>020220</drugauthorizationnumb>
        <drugdosagetext>1.0 ML/SEC INTO RIGHT ANTECUBITAL, POWER INJECTOR AND WARMER</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugdosagetext>50 MG, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>READI-CAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100422</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>READI-CAT</medicinalproduct>
        <drugdosagetext>UNK, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>DOSE: 12 HRS BEFORE SCAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>PREMEDICATED  BEFORE SCAN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>PREMEDICATED BEFORE SCAN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>PREMEDICATED BEFORE SCAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136073-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201038179NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MULTIPLE INJURIES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136074-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BAYER-201047706GPV</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>COR PULMONALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTAVIS</medicinalproduct>
        <drugdosagetext>5 A?G, UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100813</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136075-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201041145NA</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 PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>82205A</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>FREQUENCY CONTINUOUS</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>MENSTRUAL CYCLE MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101029</drugenddate>
        <drugtreatmentduration>736</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU005ZF</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>FREQUENCY CONTINUOUS</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136076-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042128NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080925</drugenddate>
        <drugtreatmentduration>213</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080925</drugenddate>
        <drugtreatmentduration>213</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136077-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201047785GPV</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTAVIS</medicinalproduct>
        <drugbatchnumb>01072A</drugbatchnumb>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>I-NEB CHAMBER GOLD AAD SYSTEM /</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>EP073P0103</drugbatchnumb>
        <drugdosagetext>LAST SHIPMENT:10-NOV-2010</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136078-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-000409</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GALLBLADDER INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136079-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042078NA</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136081-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042079NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070819</drugenddate>
        <drugtreatmentduration>397</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081109</drugenddate>
        <drugtreatmentduration>300</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136082-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201020098NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BILOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>883</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090501</drugenddate>
        <drugtreatmentduration>548</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO TRI-CYCLEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NERVOUS SYSTEM</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136083-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-000004</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST 150</medicinalproduct>
        <drugbatchnumb>94570A</drugbatchnumb>
        <drugauthorizationnumb>020220</drugauthorizationnumb>
        <drugdosagetext>189 ML</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101124</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST 150</medicinalproduct>
        <drugauthorizationnumb>020220</drugauthorizationnumb>
        <drugindication>UROGRAM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136084-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAYER-201010993BYL</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>HEPATIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>AFTER MORNING, AFTER DINNER</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100218</drugenddate>
        <drugtreatmentduration>37</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugdosagetext>AFTER MORNING, AFTER LUNCH, AFTER DINNER</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS CHOLESTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>AFTER MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugdosagetext>0.25 MG (DAILY DOSE), , ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>AFTER MORNING, AFTER DINNER</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STRESS ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UREPEARL</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIRUDOID</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISODINE</medicinalproduct>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136085-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042145NA</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>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080801</drugenddate>
        <drugtreatmentduration>152</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080801</drugenddate>
        <drugtreatmentduration>152</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136086-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042068NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090304</drugenddate>
        <drugtreatmentduration>259</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136087-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</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>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACARDIAC THROMBUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080505</drugenddate>
        <drugtreatmentduration>340</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080505</drugenddate>
        <drugtreatmentduration>340</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILK OF MAGNESIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136088-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100819</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201025149NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BILIARY DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY TEST URINE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugbatchnumb>64364A</drugbatchnumb>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071101</drugenddate>
        <drugtreatmentduration>122</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugindication>ACNE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136089-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100701</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201028987NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <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>YASMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136090-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042087NA</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>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE INJURIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASYLOL</medicinalproduct>
        <drugauthorizationnumb>020304</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061031</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136091-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042138NA</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>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081001</drugenddate>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136092-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RU-BAYER-201047768GPV</companynumb>
    <primarysource>
      <reportercountry>RUSSIAN FEDERATION</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOCHONDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANGELIQ</medicinalproduct>
        <drugdosagetext>1 DF (DAILY DOSE), QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101014</drugenddate>
        <drugtreatmentduration>212</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANGELIQ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIOSTATION, LOVASTATIN</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIOMAGNYL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENAP</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCOR</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101014</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136093-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201041875NA</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>INJECTION SITE DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>BETAJECT</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCOS NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136094-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201016262NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACTIVATED PROTEIN C RESISTANCE TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTINUCLEAR ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACTOR V LEIDEN MUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMOBILISATION PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
        <drugtreatmentduration>1035</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136095-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BAYER-2010-000551</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN SODIUM</medicinalproduct>
        <drugdosagetext>550 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101014</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOZITEC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALPEROS D3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID/HESPERIDIN/RUSCUS ACULEATUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFFU K</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136096-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BAYER-201047927GPV</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST 370</medicinalproduct>
        <drugbatchnumb>0381OC</drugbatchnumb>
        <drugauthorizationnumb>020220</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136097-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-000975</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>GALLBLADDER INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136098-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201040415NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ARTERIAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2557</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136099-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100423</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200939451NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENE MUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCOAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN C INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN S INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS MESENTERIC VESSEL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136100-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201012830NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIAL HYPERREACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONCUSSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED ACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE STRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURITIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICULITIS CERVICAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080125</drugenddate>
        <drugtreatmentduration>86</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>NECK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080120</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>NECK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>RADICULITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
        <drugdosagetext>1000 MG (DAILY DOSE), BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080128</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
        <drugindication>NECK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKELAXIN</medicinalproduct>
        <drugdosagetext>UP TO TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKELAXIN</medicinalproduct>
        <drugdosagetext>B.I.D. TO T.I.D, STOPPED BETWEEN MAY-AUG-2008</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NECK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKELAXIN</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugdosagetext>ONE TO TWO TABLETS DAILY , STOPPED BETWEEN MAY-AUG-2008</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
        <drugdosagetext>STOPPED BETWEEN MAY-AUG-2008</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDODERM</medicinalproduct>
        <drugdosagetext>STOPPED BETWEEN MAY-AUG-2008</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugdosagetext>STOPPED BETWEEN MAY-AUG-2008</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136101-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201023575NA</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>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100115</drugenddate>
        <drugtreatmentduration>152</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEXOFENDAINE NOS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091113</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136102-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200941485NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOCAL NODULAR HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</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>20050501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
        <drugtreatmentduration>974</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLU VACCINATION</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIORICET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136104-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101204</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>FR-BAYER-2010-000544</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECTOPIC PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY WITH CONTRACEPTIVE DEVICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 A?G, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101025</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136105-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101205</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ASTRAZENECA-2010SE56109</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL DETACHMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136110-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101205</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201041564NA</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>MULTIPLE INJURIES</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>YASMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136111-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101205</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201041566NA</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>MULTIPLE INJURIES</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>YASMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136115-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101205</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-001000</companynumb>
    <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 INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE + ETHINYLESTRADIOL 20A?G (24+4)</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136116-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101205</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201041568NA</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>MULTIPLE INJURIES</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>YASMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136117-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101205</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100330</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TYCO HEALTHCARE/MALLINCKRODT-T201001011</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>EYE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TECHNESCAN</medicinalproduct>
        <drugbatchnumb>9016</drugbatchnumb>
        <drugauthorizationnumb>018321</drugauthorizationnumb>
        <drugdosagetext>UNK UNK, SINGLE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100330</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRA-TECHNEKOW</medicinalproduct>
        <drugbatchnumb>0048</drugbatchnumb>
        <drugdosagetext>UNK UNK, SINGLE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100330</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136118-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101205</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100319</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TYCO HEALTHCARE/MALLINCKRODT-T201000878</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TECHNETIUM TC 99M SESTAMIBI</medicinalproduct>
        <drugbatchnumb>9030</drugbatchnumb>
        <drugauthorizationnumb>078098</drugauthorizationnumb>
        <drugdosagetext>UNK UNK, SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RADIOISOTOPE SCAN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100310</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRA-TECHNEKOW</medicinalproduct>
        <drugdosagetext>27.5 MCI, SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RADIOISOTOPE SCAN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100310</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136119-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101205</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100218</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TYCO HEALTHCARE/MALLINCKRODT-T201000687</companynumb>
    <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>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TECHNETIUM TC 99M SESTAMIBI</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>078098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CARDIAC STRESS TEST</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100217</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRA-TECHNEKOW</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CARDIAC STRESS TEST</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100217</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81MG</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136120-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101205</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100301</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TYCO HEALTHCARE/MALLINCKRODT-T200901734</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>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TECHNESCAN</medicinalproduct>
        <drugbatchnumb>9008</drugbatchnumb>
        <drugauthorizationnumb>018321</drugauthorizationnumb>
        <drugdosagetext>UNK, SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE SCAN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090911</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRA-TECHNEKOW</medicinalproduct>
        <drugdosagetext>25 MCI, SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE SCAN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090911</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136121-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101205</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101007536</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>107.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugdosagetext>2 DOSES TOTAL</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136122-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101205</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13018BP</companynumb>
    <primarysource>
      <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>GYNAECOMASTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIPPLE PAIN</reactionmeddrapt>
      </reaction>
      <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>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG</drugdosagetext>
        <drugindication>ANGIOPLASTY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>STENT PLACEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugindication>HEART RATE INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZAPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136123-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101205</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13013BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GYNAECOMASTIA</reactionmeddrapt>
      </reaction>
      <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>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugdosagetext>0.8 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136124-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101205</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-016096-10</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>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISION SITE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>020733</drugauthorizationnumb>
        <drugdosagetext>DOSING INFORMATION UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE</medicinalproduct>
        <drugauthorizationnumb>020733</drugauthorizationnumb>
        <drugdosagetext>DOSING INFORMATION UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBUTEX</medicinalproduct>
        <drugauthorizationnumb>020733</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN DOSING DETAILS</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136125-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101205</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-014649-10</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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRE-EXISTING CONDITION IMPROVED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOBACCO USER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>020733</drugauthorizationnumb>
        <drugdosagetext>DOSING INFORMATION UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136126-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101205</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-018756-10</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>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOMICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>022410</drugauthorizationnumb>
        <drugdosagetext>DOSING INFORMATION IS UNKNOWN.</drugdosagetext>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136127-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101205</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-018600-10</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>BIPOLAR I DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>020733</drugauthorizationnumb>
        <drugdosagetext>DOSING INFORMATION UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136128-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101205</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101120</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-016886-10</companynumb>
    <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>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>020733</drugauthorizationnumb>
        <drugdosagetext>DOSAGE INFORMATION UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136129-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101205</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-016370-10</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>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF-INJURIOUS IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBSTANCE ABUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>022410</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN DOSING DETIALS</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>022410</drugauthorizationnumb>
        <drugdosagetext>DOSING INFORMATION UNKNOWN; SUBLINGUAL FILM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136130-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101205</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-016609-10</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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FREQUENT BOWEL MOVEMENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUNGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBSTANCE ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>020733</drugauthorizationnumb>
        <drugdosagetext>DOSING INFORMATION UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136131-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101205</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101101010</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALCOHOL WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>USTEKINUMAB</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>USTEKINUMAB</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOPROFEN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136132-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101205</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101006442</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COLD-FX</medicinalproduct>
        <drugindication>MUSCULOSKELETAL DISCOMFORT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MATERNA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTEF</medicinalproduct>
        <drugindication>HYPOGLYCAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136133-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101205</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-JNJFOC-20100904499</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>104</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOSMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136134-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101205</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20101200260</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERURICAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONEAL TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRIN</medicinalproduct>
        <drugdosagetext>START DATE REPORTED AS FUTURE DATE OF 28-DEC-2010</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136135-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101205</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2010146558</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugdosagetext>31.3 MG/L, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136136-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101205</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010125033</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOVIAZ</medicinalproduct>
        <drugauthorizationnumb>022030</drugauthorizationnumb>
        <drugdosagetext>8 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTONIC BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOTIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HAIR DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136137-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101205</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010162931</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>RESPIRATORY TRACT OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>200 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101104</drugenddate>
        <drugtreatmentduration>37</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101104</drugenddate>
        <drugtreatmentduration>37</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACINON</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101104</drugenddate>
        <drugtreatmentduration>37</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101104</drugenddate>
        <drugtreatmentduration>37</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYONAL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101104</drugenddate>
        <drugtreatmentduration>37</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INFLUENZA VIRUS VACCINE POLYVALENT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISODINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136138-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101205</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2010159094</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FLUTTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136139-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101205</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20090406226</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFLAMMATORY BOWEL DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESALAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIDOPHILUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAL CONTRACEPTION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136140-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101205</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20101104128</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DACTYLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUSTULAR PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>USTEKINUMAB</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-CODAMOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136141-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101205</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-AMGEN-BRASP2010005220</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2X/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136142-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101205</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AMGEN-FRASP2010005377</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>AORTIC ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136143-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101205</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-JPNSP2010006220</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25MG TWICE WEEKLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100915</drugenddate>
        <drugtreatmentduration>168</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugdosagetext>4 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100608</drugenddate>
        <drugtreatmentduration>69</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugdosagetext>2 MG, 3X/WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100825</drugenddate>
        <drugtreatmentduration>78</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugdosagetext>2 MG, 4X/WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100917</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugdosagetext>2 MG, 2X/WEEK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugdosagetext>2 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugdosagetext>300 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100608</drugenddate>
        <drugtreatmentduration>371</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>60 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100609</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACINON</medicinalproduct>
        <drugdosagetext>75 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100608</drugenddate>
        <drugtreatmentduration>882</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBAMIPIDE</medicinalproduct>
        <drugdosagetext>100 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100609</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAL</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100609</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136144-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101205</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-AMGEN-IRLSP2010005382</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULPHASALAZINE</medicinalproduct>
        <drugdosagetext>1.5 G, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE SULFATE</medicinalproduct>
        <drugdosagetext>400 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELTROXIN</medicinalproduct>
        <drugdosagetext>100 UG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>70 MG, WEEKLY ON A SATURDAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>75 MG NOCTE, 200 MG MANE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTIUM</medicinalproduct>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALODEX</medicinalproduct>
        <drugdosagetext>50 MG NOCTE UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>15 MG, 1X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136145-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101205</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-BRISTOL-MYERS SQUIBB COMPANY-15400849</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>
      <patientweight>135</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONGLYZA</medicinalproduct>
        <drugauthorizationnumb>022350</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COVERSYL PLUS</medicinalproduct>
        <drugdosagetext>TABS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCOMET</medicinalproduct>
        <drugdosagetext>TABS, DURATION 3 1/2 YRS</drugdosagetext>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>TABS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101109</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>TABS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMICRON</medicinalproduct>
        <drugdosagetext>FORMLN:TAB DIAMICRON-XR, 3 1/2 YRS DURATION</drugdosagetext>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101109</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136146-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101205</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BRISTOL-MYERS SQUIBB COMPANY-15231418</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>RECENT INFUSION :400MG/M2, FORMULATION 5MG/ML, INTERUPPTED ON 01AUG10.DRUG RESTARTED ON 16AUG10</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEAD AND NECK CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100721</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>1 IN 3 WEEK  ON 21JUL2010:100MG/M2 3.8095MG/M2(80MG/M2)-ONGOING</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEAD AND NECK CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100721</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CILENGITIDE</medicinalproduct>
        <drugdosagetext>RECENT INFUSION:2000MG ,RECENT INFUSION 24JUL10,INTERUPPTED ON 01AUG10.DOSE REINTRODUCED ON 16AUG10</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEAD AND NECK CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100721</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>CONTINOUS INFUSION FROM DAY 1 TO DAY 4. ON 21JUL2010:1000MG/M2 DOSE REDUCED TO 800MG/M2(ONGOING)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEAD AND NECK CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100721</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136147-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101205</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15410822</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugauthorizationnumb>020357</drugauthorizationnumb>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE AND ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136148-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101205</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BRISTOL-MYERS SQUIBB COMPANY-15414923</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>DOSE REDUCED TO 2.5MG/D</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136149-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101205</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15414493</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>ACUTE PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED: SAXAGLIPTIN</medicinalproduct>
        <drugauthorizationnumb>022350</drugauthorizationnumb>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100813</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED: PLACEBO</medicinalproduct>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100813</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugauthorizationnumb>020357</drugauthorizationnumb>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRATES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136150-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101205</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-15354988</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>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>STARTED AT 30MG INCREASED TO 45MG FROM 12OCT10  DECREASED TO 15MG ON 5NOV10</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOCTRAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100511</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136151-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101205</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-15418718</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>RECOMMENCED TITRATED DOSE 20MG; MAINTAINENCE DOSE 5MG/DAY.</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136152-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101205</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-JPNSP2010005214</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>LYMPHOCYTE COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2X/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugdosagetext>35 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FRACTURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL</medicinalproduct>
        <drugdosagetext>0.5 UG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FRACTURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAG-LAX</medicinalproduct>
        <drugdosagetext>110 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>1 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STARSIS</medicinalproduct>
        <drugdosagetext>30 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERGLYCAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS CITRATE</medicinalproduct>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136153-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101205</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-JPNSP2010005218</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136154-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101205</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-JPNSP2010005216</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugdosagetext>6 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFACALCIDOL</medicinalproduct>
        <drugdosagetext>1 DF, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugdosagetext>200 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPEN</medicinalproduct>
        <drugdosagetext>1 DF, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT - SLOW RELEASE</medicinalproduct>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugdosagetext>35 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOBAN</medicinalproduct>
        <drugdosagetext>1 DF, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugdosagetext>1 DF, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>15 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100624</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136155-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-15398613</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>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAXAGLIPTIN</medicinalproduct>
        <drugdosagetext>FORM: TABLET.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101014</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>FORM: TABLET,ALSO TAKEN ON 15NOV2010.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYSLEE</medicinalproduct>
        <drugdosagetext>FORM: TABLET.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101014</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>FORM: TABLET.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUVELA N</medicinalproduct>
        <drugdosagetext>FORM: GRANULE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>TABLET.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SANCOBA</medicinalproduct>
        <drugdosagetext>EYE DROPS.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010413</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136156-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-AMGEN-MEXSP2010005002</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 X WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136157-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-GBRSP2010004613</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101002</drugenddate>
        <drugtreatmentduration>1874</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYL SALICYLIC ACID USP BAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136158-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-GBRSP2010005036</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>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, WEEKLY</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136159-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-JPNSP2010005045</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATYPICAL MYCOBACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, ONCE A DAY</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugdosagetext>2 MG, 2X/WEEK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugdosagetext>1 MG, 1X/DAY</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136160-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-JPNSP2010004510</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KLEBSIELLA SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA PAROXYSMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2X/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100721</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
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        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
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        <drugenddate>20100606</drugenddate>
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      <drug>
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        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100702</drugstartdate>
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        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UBRETID</medicinalproduct>
        <drugdosagetext>5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>URINARY RETENTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100622</drugstartdate>
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        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
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        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NERVOUSNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100603</drugstartdate>
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        <drugtreatmentduration>50</drugtreatmentduration>
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      <drug>
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        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
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        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
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        <medicinalproduct>PROMAC /JPN/</medicinalproduct>
        <drugdosagetext>150 MG, 1X/DAY</drugdosagetext>
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        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
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      <drug>
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        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100605</drugstartdate>
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        <drugtreatmentduration>48</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOFERMIN</medicinalproduct>
        <drugdosagetext>1 G, 1X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100603</drugstartdate>
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        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEPRIDIL</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100605</drugstartdate>
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        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL                         /00802602/</medicinalproduct>
      </drug>
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    <receiver></receiver>
    <patient>
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    <patient>
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        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
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    <safetyreportid>7136166-2</safetyreportid>
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    <patient>
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        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
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        <medicinalproduct>ILOPROST INHALATION SOLUTION 5UG US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
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        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
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        <medicinalproduct>SILDENAFIL CITRATE</medicinalproduct>
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        <drugcharacterization>2</drugcharacterization>
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      <reportercountry>UNITED STATES</reportercountry>
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    <receiver></receiver>
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      <reaction>
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      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
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        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
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        <medicinalproduct>LIPITOR</medicinalproduct>
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        <medicinalproduct>FERROUS GLUCONATE</medicinalproduct>
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        <medicinalproduct>LANOXIN</medicinalproduct>
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        <medicinalproduct>ALTACE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
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    <receiver></receiver>
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    <safetyreportid>7136169-8</safetyreportid>
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    <receiver></receiver>
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      <drug>
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        <medicinalproduct>VIAGRA</medicinalproduct>
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        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136170-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091021</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2006-15083</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>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILOPROST INHALATION SOLUTION 5UG US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>5 UG, 6-9 X DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070621</drugenddate>
        <drugtreatmentduration>301</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE W/SALBUTAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136171-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BIOGENIDEC-2009BI041988</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>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE RUPTURE OF MEMBRANES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugindication>ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugindication>GESTATIONAL DIABETES</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136172-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-BIOGENIDEC-2010BI001833</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>49</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IMMUNE RECONSTITUTION SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <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>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091201</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugindication>IMMUNE RECONSTITUTION SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100222</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136173-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI004111</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>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</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>20100121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAIN KILLER (NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>A LOT OF OTHER PILLS (NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136174-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI005477</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>82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNE RECONSTITUTION SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY</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>20070426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugindication>MUSCLE SPASTICITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugindication>FATIGUE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIPLE VITAMIN</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</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>TRAZODONE HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136175-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BIOGENIDEC-2010BI017108</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>CARDIOPULMONARY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNE RECONSTITUTION SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHLEBITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100426</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIORESAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136176-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI017169</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>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG ADENOCARCINOMA STAGE IV</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugbatchnumb>P68091</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZIDE</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>ROSUVASTATIN</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>FENOFIBRATE</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>CYMBALTA</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>VALIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136177-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-BIOGENIDEC-2010BI018428</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>IMMUNE RECONSTITUTION SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136178-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BIOGENIDEC-2010BI020351</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>QUADRIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIPRETERAX</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVONORM</medicinalproduct>
        <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>LANTUS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136179-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BIOGENIDEC-2010BI025733</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IMMUNE RECONSTITUTION SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <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>20081013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100726</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136180-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI029927</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>99</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLEPHAROSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC FATIGUE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS EROSIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEARING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASTOIDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NYSTAGMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL HERPES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</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>20100305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100723</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUMS (CALCIUM CARBONATE)</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136181-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI031429</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</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>20100818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136182-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI032771</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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMATOMA</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>20080411</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugindication>BIPOLAR I DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL INHALER</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMIDONE</medicinalproduct>
        <drugindication>ESSENTIAL TREMOR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDODRINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>ORTHOSTATIC HYPOTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugindication>DEMENTIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugindication>BIPOLAR I DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROQUINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLORINEF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136183-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI033259</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>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC FRACTURE</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>20100416</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136184-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BIOGENIDEC-2010BI033687</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090901</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136185-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI035014</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>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROTISING FASCIITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136186-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI035104</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>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070216</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136187-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI035711</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>THYROID ADENOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100222</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136189-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI035722</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>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100318</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136190-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI036126</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugbatchnumb>P68082</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100216</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136191-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI036272</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>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136192-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI036692</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>82</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER IN SITU</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</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>20100507</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136193-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BIOGENIDEC-2010BI037289</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136194-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI037901</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>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100302</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136195-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI038260</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>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100618</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136196-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI038299</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100818</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136197-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI038732</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136198-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI038773</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>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</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>20080403</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136199-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BIOGENIDEC-2010BI040449</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CENTRAL NERVOUS SYSTEM LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136200-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-BIOGENIDEC-2010BI040575</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</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>COGNITIVE DISORDER</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>20090901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENESTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTYNIN CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136201-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BIOGENIDEC-2010BI041225</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugbatchnumb>MS</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136202-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041336</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>AUTOIMMUNE HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080813</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136203-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-BIOGENIDEC-2010BI041455</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>TYSABRI</medicinalproduct>
        <drugbatchnumb>P68108</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136204-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041459</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>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</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>20100319</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136205-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041465</companynumb>
    <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>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100617</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136206-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041470</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>OPPORTUNISTIC INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136208-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041533</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>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOPHLEBITIS SUPERFICIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081022</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136209-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041539</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>83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICAL SPINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugbatchnumb>P68104</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPASTICITY MEDICATION (NOS)</medicinalproduct>
        <drugindication>MUSCLE SPASTICITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136210-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-BIOGENIDEC-2010BI041676</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</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>SEMINOMA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100722</drugstartdate>
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        <drugenddate>20101104</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136211-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041711</companynumb>
    <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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HORMONE LEVEL ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</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>20090403</drugstartdate>
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  <safetyreport>
    <safetyreportid>7136212-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <seriousnesshospitalization>1</seriousnesshospitalization>
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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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081229</drugstartdate>
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    </patient>
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  <safetyreport>
    <safetyreportid>7136213-8</safetyreportid>
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    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041738</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>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER DISORDER</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090218</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136214-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
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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>
      <patientonsetage>46</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001224</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136215-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2009BI002936</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>ABDOMINAL STRANGULATED HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVAL CANCER STAGE I</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100310</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136216-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI010999</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>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136217-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI028516</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>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WERNICKE'S ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32115</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136218-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI030118</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020510</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136219-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI030352</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>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLOLISTHESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136220-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI032022</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>FALL</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>20090609</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136221-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI035599</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>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031028</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136222-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI036158</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>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATICA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136223-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI036161</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>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100402</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136224-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-BIOGENIDEC-2010BI038460</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPHTHALMOPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</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>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136225-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI038634</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>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32129</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>ASTHENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136226-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI039594</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>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32129</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136227-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI040170</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>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990927</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136228-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-BIOGENIDEC-2010BI041260</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>BEDRIDDEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT 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>20091014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136229-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BIOGENIDEC-2010BI041345</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRAUMATIC BRAIN INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136230-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BIOGENIDEC-2010BI041356</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>4</patientweight>
      <reaction>
        <reactionmeddrapt>GASTRIC DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL DRUGS AFFECTING FOETUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136231-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-BIOGENIDEC-2010BI041471</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>GASTROINTESTINAL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136232-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041807</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32116</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136233-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041810</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>122</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960601</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>7136234-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041828</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE LEIOMYOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100514</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136235-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041866</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>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS (NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136236-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041868</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>BLOOD IRON DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</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>7136237-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041872</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>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRAUMATIC HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>R01002</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136238-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041874</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>BASAL CELL CARCINOMA</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>20040501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136239-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041875</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32135</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136240-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-BIOGENIDEC-2010BI041912</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEG AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>100004A</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136241-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041920</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>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE COMPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32120</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136242-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041928</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>INTRACRANIAL ANEURYSM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32121</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136243-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041941</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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INVESTIGATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONTROL OF LEGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136244-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI004911</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136245-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI008747</companynumb>
    <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>COLOUR BLINDNESS ACQUIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA FACIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL FIELD DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136246-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100608</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI010948</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>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROGENIC BOWEL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100325</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136247-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI013338</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA FACIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOPOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPERATURE INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>PULMONARY THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136248-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI013462</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED TENDENCY TO BRUISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100415</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136249-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI018334</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>BLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASTICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPYRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136250-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI018501</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR VENOUS ACCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VEIN DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070808</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136251-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI019024</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>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100507</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMPRIDINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100519</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMPRIDINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100520</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136252-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI019773</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060921</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136253-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI020113</companynumb>
    <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>FEELING ABNORMAL</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>20061128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101025</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136254-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI020364</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>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</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>20080815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100524</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136255-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI021575</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100330</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136256-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI022802</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGAMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONTROL OF LEGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR VENOUS ACCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRABISMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090508</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136257-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI023878</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>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090706</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136258-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI024196</companynumb>
    <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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090112</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136259-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI027215</companynumb>
    <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</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>20100626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100729</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136260-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI027491</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100723</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136261-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI027909</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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090505</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136262-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI029193</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>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100907</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136263-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI029534</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>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugbatchnumb>P68082</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136264-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI029735</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>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugbatchnumb>P68101</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100203</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136265-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI031252</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>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugbatchnumb>P68098</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070716</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050210</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136266-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI031610</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 SPASTICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080416</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136267-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI031632</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>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090707</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136269-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI031894</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>BLOOD PRESSURE INCREASED</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>20080821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100712</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136270-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI031971</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGRAPHIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136271-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI032046</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>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</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>20071004</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136272-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI032516</companynumb>
    <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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPYRA</medicinalproduct>
        <drugindication>GAIT DISTURBANCE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136273-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI032739</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR VENOUS ACCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081112</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136274-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI033306</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>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</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>20080421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136275-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI036036</companynumb>
    <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>PROGRESSIVE MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070209</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136276-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI036193</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>JC VIRUS TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050131</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100920</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136277-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI036444</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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990905</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136278-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI037626</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</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>20091016</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136279-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI037629</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>ASTHENIA</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>20080828</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136280-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI038135</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>JC VIRUS TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100727</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136281-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI038145</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>JC VIRUS TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100819</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136282-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI038262</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>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080922</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136283-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI039452</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070222</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136284-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI039617</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICOBRACHIAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</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>20080910</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136285-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI039690</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>CHOKING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100205</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136286-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI039910</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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SPRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100908</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136287-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI039989</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>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>20100831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100928</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136288-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI040160</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>NERVE COMPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090603</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136289-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI040501</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>HERPES ZOSTER</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>20090501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136290-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI040640</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136291-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI040910</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>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>CONVULSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136292-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041065</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>BLOOD PRESSURE INADEQUATELY CONTROLLED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</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>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136293-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041091</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>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100625</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136294-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041319</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>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100309</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136295-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041323</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</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136296-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041454</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101112</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136297-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041496</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>ENCEPHALITIS HERPES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080703</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136298-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041670</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>NUCLEAR MAGNETIC RESONANCE IMAGING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090618</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136299-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041681</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>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136300-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041686</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>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136301-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041700</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101028</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136302-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041701</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BAND SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <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>20100812</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136303-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041710</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>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080120</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136304-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041727</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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090625</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136305-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041729</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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136306-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041736</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>URINE ODOUR ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</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>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136307-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041747</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <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>20101104</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136308-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041748</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>INFLUENZA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080325</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031108</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136309-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041752</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100923</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136310-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041758</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>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101027</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136311-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041761</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 RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100825</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136312-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041765</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>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLADDER MEDICATION (NOS)</medicinalproduct>
        <drugindication>URINARY RETENTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101121</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136313-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041770</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>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100211</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136314-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041803</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>UTERINE LEIOMYOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080121</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136315-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041838</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101105</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136316-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041839</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>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100507</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136317-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041843</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050417</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136318-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041848</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>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090903</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136319-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041849</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>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070313</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136320-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041851</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>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101117</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136321-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041852</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>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136322-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041855</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>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090929</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136323-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041857</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>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100312</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136324-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041864</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>DEAFNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081003</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136325-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041865</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>PHARYNGITIS STREPTOCOCCAL</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>20070326</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136326-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041870</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>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</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>20090527</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136327-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041873</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>MOTION SICKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136328-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041878</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010103</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136329-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041880</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>CYSTITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991005</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136330-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041881</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</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>20100910</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136331-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041883</companynumb>
    <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>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
        <drugindication>TACHYCARDIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136332-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041885</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>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090331</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136333-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041886</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>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugbatchnumb>P68101</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136334-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041888</companynumb>
    <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>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100520</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136335-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041889</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</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>20090129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136336-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041890</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 RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100723</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136337-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041891</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>CYSTITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090312</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136338-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041896</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>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100708</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136339-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041901</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>CHILLS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugbatchnumb>P68101</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136340-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041902</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101027</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136341-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041910</companynumb>
    <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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</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>20101115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136342-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041911</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060907</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136343-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041913</companynumb>
    <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>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050131</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061019</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136344-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041915</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>ADVERSE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080326</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021230</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136345-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041916</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>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS STREPTOCOCCAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080221</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136346-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041917</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>FATIGUE</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>20080609</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136347-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041921</companynumb>
    <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>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090807</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136348-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041923</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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</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>20080916</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136349-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041924</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>MALAISE</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>7136350-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041926</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>MICTURITION URGENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100604</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>NORMAL TENSION GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMANTADINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FATIGUE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136351-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041929</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080416</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136352-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041930</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>ALLERGIC COUGH</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>20080212</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136353-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041932</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</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>20071119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000612</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136354-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041939</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>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugbatchnumb>P68101</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136355-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041940</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136356-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041942</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136357-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041943</companynumb>
    <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>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070912</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136358-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041945</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>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136359-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041946</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136360-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041947</companynumb>
    <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>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</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>20070108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070314</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136361-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041948</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>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101025</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136362-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041949</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>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001229</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136363-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041950</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>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugbatchnumb>P68099</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136364-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041951</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091006</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136365-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041959</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>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100520</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090715</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136366-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041960</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>MASTITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100804</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136367-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041961</companynumb>
    <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>BLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPYRA</medicinalproduct>
        <drugindication>BALANCE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136368-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041963</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>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS (NOS)</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-CORTEF</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136369-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041964</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>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100317</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136370-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041965</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070808</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136371-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041966</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>20050107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101018</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136372-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041967</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>POOR VENOUS ACCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VEIN DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080116</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136373-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101127</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041998</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>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101025</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136374-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042008</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>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100823</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136375-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042014</companynumb>
    <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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100422</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136376-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042018</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 LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080804</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136377-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042021</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101126</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136378-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042027</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>SINUSITIS</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>7136379-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042031</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>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</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>20100930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPYRA</medicinalproduct>
        <drugindication>GAIT DISTURBANCE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136380-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042033</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 UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE AFFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090810</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136381-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042035</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>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136382-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042042</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>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091124</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136383-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042043</companynumb>
    <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 PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091230</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136384-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042046</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>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136385-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042048</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>PYREXIA</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>20100114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136386-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042049</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>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080724</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136387-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042051</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>HYPOAESTHESIA FACIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100412</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136388-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042054</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EXOPHTHALMOS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA FACIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080416</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136389-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042067</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101005</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136390-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042068</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HERNIA</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>20100430</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136391-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042073</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>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE REMOVAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100507</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080905</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136392-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042076</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>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070905</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PILL FOR MS (NOS)</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136393-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042077</companynumb>
    <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>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIORBITAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081007</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136394-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042080</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020510</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136395-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042086</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>20080507</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136396-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042087</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100428</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136397-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042089</companynumb>
    <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>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070209</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136398-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042090</companynumb>
    <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>
        <drugstartdate>20070611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136399-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042091</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>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</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>20100927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090713</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136400-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042094</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>PNEUMONIA PRIMARY ATYPICAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136401-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042095</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 IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100728</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136402-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042097</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101004</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136403-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042101</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>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090626</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136404-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042102</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>LYMPHADENOPATHY</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>20090729</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136405-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042106</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>JC VIRUS TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080624</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080605</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136407-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042107</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>DRUG SPECIFIC ANTIBODY PRESENT</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>7136408-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042111</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>EAR DISCOMFORT</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>20101111</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136409-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042112</companynumb>
    <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>20090610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100318</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136410-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042115</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101111</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136411-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042116</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136412-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042117</companynumb>
    <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>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080516</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136413-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042118</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100715</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136414-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042119</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>NASAL OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100118</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136415-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <companynumb>US-BIOGENIDEC-2010BI042121</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
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      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <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>20081103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101025</drugenddate>
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  <safetyreport>
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    <serious>2</serious>
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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>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080827</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136417-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
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    <companynumb>US-BIOGENIDEC-2010BI042125</companynumb>
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      <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>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <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>20091030</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136418-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
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    <companynumb>US-BIOGENIDEC-2010BI042126</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</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>20101115</drugstartdate>
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    </patient>
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  <safetyreport>
    <safetyreportid>7136419-8</safetyreportid>
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    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
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    <receivedate>20101206</receivedate>
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    <companynumb>US-BIOGENIDEC-2010BI042127</companynumb>
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      <reportercountry>UNITED STATES</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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      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100312</drugstartdate>
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    </patient>
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  <safetyreport>
    <safetyreportid>7136420-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
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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>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100422</drugstartdate>
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    </patient>
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  <safetyreport>
    <safetyreportid>7136421-6</safetyreportid>
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    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
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    <companynumb>US-BIOGENIDEC-2010BI042133</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>7136422-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
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    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042135</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>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091023</drugstartdate>
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    </patient>
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  <safetyreport>
    <safetyreportid>7136423-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042137</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>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100716</drugstartdate>
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    </patient>
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  <safetyreport>
    <safetyreportid>7136424-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
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    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042170</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>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</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>20080801</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136425-3</safetyreportid>
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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>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
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      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
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        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101015</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136426-5</safetyreportid>
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      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
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        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
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        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101011</drugstartdate>
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  <safetyreport>
    <safetyreportid>7136427-7</safetyreportid>
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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>
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      <reaction>
        <reactionmeddrapt>VACCINATION COMPLICATION</reactionmeddrapt>
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        <drugcharacterization>1</drugcharacterization>
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        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
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    </patient>
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  <safetyreport>
    <safetyreportid>7136428-9</safetyreportid>
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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>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
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      <drug>
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        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080731</drugstartdate>
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    </patient>
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    <safetyreportid>7136429-0</safetyreportid>
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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>HEADACHE</reactionmeddrapt>
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      <drug>
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        <drugindication>MULTIPLE SCLEROSIS</drugindication>
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        <drugstartdate>20101014</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
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        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
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      <reportercountry>UNITED STATES</reportercountry>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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      <drug>
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        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
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    </patient>
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      <reportercountry>UNITED STATES</reportercountry>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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      <patientonsetageunit>801</patientonsetageunit>
      <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>20090319</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081202</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136432-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042202</companynumb>
    <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>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090813</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136433-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042210</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>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <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>20101111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100427</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136434-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042211</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>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070223</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136435-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042216</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>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100824</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136436-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042217</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>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</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>20100224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136437-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042218</companynumb>
    <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>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</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>7136438-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042220</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>FOLLICULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136439-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042228</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>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136440-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042232</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>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080225</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136441-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042241</companynumb>
    <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>20080415</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136442-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042248</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>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100811</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136443-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042251</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>HEPATIC MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100825</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136444-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042252</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>MUSCULOSKELETAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPYRA</medicinalproduct>
        <drugindication>GAIT DISTURBANCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136445-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042264</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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</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>20100420</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136446-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042273</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>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071126</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136447-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040514</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ACTELION-A-CH2004-06240</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 62.5 MG EU</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040320</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136448-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040715</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ACTELION-A-CH2004-06868</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>BOSENTAN TABLET 62.5 MG EU</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY FIBROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136449-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ACTELION-A-CH2004-08216</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>BOSENTAN TABLET 62.5 MG EU</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136450-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040525</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ACTELION-A-CH2004-06441</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 62.5 MG EU</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040416</drugenddate>
        <drugtreatmentduration>452</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 62.5 MG EU</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030119</drugenddate>
        <drugtreatmentduration>38</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136451-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041021</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ACTELION-A-CH2004-07847</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>BOSENTAN TABLET 125 MG EU</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 125 MG EU</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001022</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 125 MG EU</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010322</drugenddate>
        <drugtreatmentduration>150</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 125 MG EU</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010425</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 125 MG EU</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020123</drugenddate>
        <drugtreatmentduration>272</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 125 MG EU</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>250 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020625</drugenddate>
        <drugtreatmentduration>152</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136452-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ACTELION-A-CH2004-08162</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 125 MG EU</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 125 MG EU</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020102</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136453-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ACTELION-A-CH2004-08097</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>BOSENTAN TABLET 125 MG EU</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040804</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 125 MG EU</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136454-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ACTELION-A-CH2004-08096</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 62.5 MG EU</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 62.5 MG EU</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136455-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031229</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ACTELION-A-CH2003-04113</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136456-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ACTELION-A-CH2004-08099</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 125 MG EU</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 125 MG EU</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136457-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050919</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ACTELION-A-CH2005-10654</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
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        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136458-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050224</receiptdate>
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    <companynumb>DE-ACTELION-A-CH2005-08941</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136459-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050204</receiptdate>
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    <companynumb>DE-ACTELION-A-CH2005-08801</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136460-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ACTELION-A-CH2005-08799</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 125 MG EU</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050105</drugenddate>
        <drugtreatmentduration>598</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136461-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050307</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ACTELION-A-CH2005-09058</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>5</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 62.5 MG EU</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040430</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 62.5 MG EU</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136462-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-ACTELION-A-CH2005-11204</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136463-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060818</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2006-30959</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136464-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ACTELION-A-CH2004-08456</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>BOSENTAN TABLET 125 MG EU</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 125 MG EU</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040324</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136465-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050307</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ACTELION-A-CH2005-09059</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 62.5 MG EU</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
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      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 62.5 MG EU</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136466-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050530</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ACTELION-A-CH2005-09845</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136467-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2006-30948</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136468-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050307</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-ACTELION-A-CH2005-09052</companynumb>
    <primarysource>
      <reportercountry>NORWAY</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 62.5 MG EU</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040731</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 62.5 MG EU</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 62.5 MG EU</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 62.5 MG EU</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 62.5 MG EU</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>93.75 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136469-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ACTELION-A-CH2006-12682</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136470-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
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    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2006-30615</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>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
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        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
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    </patient>
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  <safetyreport>
    <safetyreportid>7136471-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060602</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2006-30610</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
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  <safetyreport>
    <safetyreportid>7136472-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080221</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2006-13366</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>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOT RETRACTION TIME SHORTENED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 125 MG US</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 125 MG US</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19460101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIL SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136473-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ACTELION-A-CH2006-12683</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136474-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061219</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ACTELION-A-CH2006-13876</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136475-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050810</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2005-30962</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136476-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-ACTELION-A-CH2006-12551</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</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>BOSENTAN TABLET 62.5 MG EU</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ILOPROST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTITHROMBOTIC AGENTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136477-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2005-30947</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136478-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060823</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2006-30621</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136479-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2006-30593</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136480-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051212</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2005-30996</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136481-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2006-30589</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136482-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2006-30611</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136483-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2006-30591</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136484-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060915</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2006-30616</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136485-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2006-30617</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136486-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20081204</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2006-13695</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>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
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      <reportercountry>CANADA</reportercountry>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>DILATATION ATRIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION VENTRICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARATRACHEAL LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
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        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
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      <drug>
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        <drugadministrationroute>048</drugadministrationroute>
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      </drug>
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      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugauthorizationnumb>021290</drugauthorizationnumb>
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        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
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    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
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        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
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    <patient>
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      <drug>
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    <patient>
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      <drug>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <patient>
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      <drug>
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        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
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      <reportercountry>UNITED STATES</reportercountry>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
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        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
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    </patient>
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    <safetyreportid>7136511-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060207</receiptdate>
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    <companynumb>NL-ACTELION-A-CH2006-11601</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
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        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugdosagetext>125 MG, BID</drugdosagetext>
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        <drugindication>AUTOIMMUNE DISORDER</drugindication>
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        <drugstartdate>20041015</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugtreatmentduration>143</drugtreatmentduration>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
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        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
      </drug>
    </patient>
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    <safetyreportid>7136512-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060320</receiptdate>
    <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>
    </sender>
    <receiver></receiver>
    <patient>
      <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>
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    <safetyreportid>7136513-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
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    <receiptdateformat>102</receiptdateformat>
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    <companynumb>US-ACTELION-A-NJ2006-30597</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>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
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    </patient>
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    <safetyreportid>7136514-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
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    <receiptdate>20060404</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ACTELION-A-CH2006-11937</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
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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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
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      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
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        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060320</drugenddate>
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    </patient>
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    <safetyreportid>7136515-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060523</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2006-30622</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
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    </patient>
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    <safetyreportid>7136516-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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    <primarysource>
      <reportercountry>FRANCE</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>SUDDEN DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
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        <drugindication>PULMONARY HYPERTENSION</drugindication>
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        <drugstartdate>20000101</drugstartdate>
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    </patient>
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  <safetyreport>
    <safetyreportid>7136517-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
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    <receivedate>20101206</receivedate>
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    <receiptdate>20070126</receiptdate>
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    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136518-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
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    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090922</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
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        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080424</drugenddate>
        <drugtreatmentduration>1527</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136519-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080328</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ACTELION-A-CH2008-20034</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136521-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080530</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ACTELION-A-CH2008-19830</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>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136522-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090822</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-ACTELION-A-CH2009-27078</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESUSCITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</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>20090812</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136523-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080428</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ACTELION-A-CH2008-20412</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136524-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030715</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ACTELION-A-CH2003-03038</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136525-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060407</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2006-30602</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136526-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070319</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ACTELION-A-CH2007-14622</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136527-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060413</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ACTELION-A-CH2006-12065</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136528-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080618</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ACTELION-A-CH2008-20959</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOPROSTENOL SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136529-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-ACTELION-A-CH2007-14239</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136530-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060417</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2006-30601</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136531-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080602</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ACTELION-A-CH2008-20766</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136532-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
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    <seriousnessdeath>1</seriousnessdeath>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060522</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2006-30588</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET UNKNOWN MG</medicinalproduct>
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        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
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  <safetyreport>
    <safetyreportid>7136533-7</safetyreportid>
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    <receiptdate>20080123</receiptdate>
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    <companynumb>TH-ACTELION-A-CH2008-19272</companynumb>
    <primarysource>
      <reportercountry>THAILAND</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNDERWEIGHT</reactionmeddrapt>
      </reaction>
      <drug>
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      <drug>
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        <medicinalproduct>PREDNISOLONE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
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    </patient>
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    <safetyreportid>7136534-9</safetyreportid>
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    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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      <drug>
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    <safetyreportid>7136535-0</safetyreportid>
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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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      <drug>
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    <patient>
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      <drug>
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        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
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    <safetyreportid>7136537-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080902</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ACTELION-A-CH2008-21753</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136538-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080303</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ACTELION-A-CH2008-19721</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040115</drugenddate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040116</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136539-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20081126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ACTELION-A-CH2008-22862</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>BOSENTAN TABLET 125 MG ROW</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136540-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030916</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ACTELION-A-CH2003-02433</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>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEPTIC ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 62.5 MG EU</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020930</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 62.5 MG EU</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>125 MCG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugdosagetext>175 MG, OD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRUSEMIDE</medicinalproduct>
        <drugdosagetext>80 MG, OD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136541-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060502</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2006-30943</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136542-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20081205</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ACTELION-A-CH2008-23014</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136543-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060405</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2006-30607</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136544-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060411</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2006-30608</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136545-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ACTELION-A-CH2004-04192</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 62.5 MG EU</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021014</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136546-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ACTELION-A-CH2008-19113</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030109</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031016</drugenddate>
        <drugtreatmentduration>279</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136547-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080902</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ACTELION-A-CH2008-21754</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136548-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-SHIRE-ALL1-2010-04690</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALVEOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEZAVANT XL</medicinalproduct>
        <drugauthorizationnumb>022000</drugauthorizationnumb>
        <drugdosagetext>4.8 G, UNKNOWN (FOUR 1.2 G TABLETS)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEZAVANT XL</medicinalproduct>
        <drugauthorizationnumb>022000</drugauthorizationnumb>
        <drugdosagetext>2.4 G, UNKNOWN (TWO 1.2 GM TABLETS)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>30 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136549-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SHIRE-SPV1-2010-02082</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSRENOL</medicinalproduct>
        <drugauthorizationnumb>021468</drugauthorizationnumb>
        <drugdosagetext>750 MG, OTHER, TOTAL DAILY DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091111</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136550-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-SHIRE-SPV1-2010-02085</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSRENOL</medicinalproduct>
        <drugauthorizationnumb>021468</drugauthorizationnumb>
        <drugdosagetext>UNK UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136551-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHIRE-ALL1-2010-06255</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>AMYLOIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSRENOL</medicinalproduct>
        <drugauthorizationnumb>021468</drugauthorizationnumb>
        <drugdosagetext>1000 MG, 3X/DAY:TID, WITH MEALS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
        <drugtreatmentduration>287</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136552-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHIRE-SPV1-2010-02078</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>31.746</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENURESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INITIAL INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTUNIV</medicinalproduct>
        <drugauthorizationnumb>022037</drugauthorizationnumb>
        <drugdosagetext>1 MG, 1X/DAY:QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101120</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136553-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SHIRE-SPV1-2010-00754</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ARTERIOVENOUS SHUNT OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTHANUM CARBONATE</medicinalproduct>
        <drugauthorizationnumb>021468</drugauthorizationnumb>
        <drugdosagetext>UNK UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTAN</medicinalproduct>
        <drugdosagetext>2000 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090817</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTAN</medicinalproduct>
        <drugdosagetext>1500 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090902</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTAN</medicinalproduct>
        <drugdosagetext>1000 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090916</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTAN</medicinalproduct>
        <drugdosagetext>500 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091203</drugenddate>
        <drugtreatmentduration>79</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTAN</medicinalproduct>
        <drugdosagetext>1000 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL</medicinalproduct>
        <drugdosagetext>.25 UG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091014</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL</medicinalproduct>
        <drugdosagetext>0.25 ?G, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091118</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL</medicinalproduct>
        <drugdosagetext>0.25 ?G, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091217</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL</medicinalproduct>
        <drugdosagetext>0.5 ?G, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NU-LOTAN</medicinalproduct>
        <drugdosagetext>25 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugdosagetext>2 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SHAKUYAKUKANZOUTOU</medicinalproduct>
        <drugdosagetext>2.5 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTECADIN</medicinalproduct>
        <drugindication>DUODENAL ULCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136554-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHIRE-ALL1-2010-06245</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.238</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSRENOL</medicinalproduct>
        <drugbatchnumb>A46204C</drugbatchnumb>
        <drugauthorizationnumb>021468</drugauthorizationnumb>
        <drugdosagetext>1000 MG, OTHER(WITH EACH MEAL)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHOSPHATE BINDER</medicinalproduct>
        <drugdosagetext>UNK MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136555-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2005BI011879</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>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011023</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICOMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METROGEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136556-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI039029</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>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080228</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136557-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041585</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>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS STREPTOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32125</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101011</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136558-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041586</companynumb>
    <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>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960501</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>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTYNIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY INCONTINENCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136559-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041588</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>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</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>19960901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136560-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041600</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32135</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAJEL</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136561-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041603</companynumb>
    <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>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136562-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041791</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</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>20020301</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>7136563-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041792</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>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS AT WORK</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>7136564-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041797</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136565-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041798</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>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100915</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136566-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041799</companynumb>
    <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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010810</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>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136567-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041805</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>BRADYPHRENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SECONDARY PROGRESSIVE MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPERATURE REGULATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOCAL CORD DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000301</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>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136568-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041824</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>CYSTITIS</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>7136569-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041846</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>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101119</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136570-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041850</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100515</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136571-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041938</companynumb>
    <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>AVONEX</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136572-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101121</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041952</companynumb>
    <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>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPYRA</medicinalproduct>
        <drugindication>GAIT DISTURBANCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136573-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041954</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>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136574-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041988</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>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101123</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136575-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041990</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 PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136576-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042000</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</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>20100612</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136577-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042002</companynumb>
    <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>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091208</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136578-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042005</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>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136579-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042028</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>HEART VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136580-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2008BI022138</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>53</patientweight>
      <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>19980301</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>20080701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136581-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2007BI023894</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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100325</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136582-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2008BI003775</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>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080208</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136583-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090414</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2009BI011674</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>FATIGUE</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>20080702</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136584-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090923</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2009BI030614</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>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090518</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136585-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2009BI035944</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071029</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136586-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2009BI036196</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>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071214</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136587-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2009BI036215</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>HEADACHE</reactionmeddrapt>
      </reaction>
      <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>20071116</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136588-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2009BI038660</companynumb>
    <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>KNEE OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENISCUS LESION</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>20080326</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136589-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2009BI039041</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>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070626</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136590-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-PAR PHARMACEUTICAL, INC-2010SCPR002268</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CUSHING'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DISPENSING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugauthorizationnumb>088148</drugauthorizationnumb>
        <drugdosagetext>5 MG, 4 DD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPIRONE HCL</medicinalproduct>
        <drugdosagetext>10 MG, 3DD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136591-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-PAR PHARMACEUTICAL, INC-2010SCPR002269</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CUSHING'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DISPENSING ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugauthorizationnumb>088148</drugauthorizationnumb>
        <drugdosagetext>5 MG, 2DD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136592-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
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    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-001154</companynumb>
    <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 INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE + ETHINYLESTRADIOL 20A?G (24+4)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136593-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-001229</companynumb>
    <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 INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136594-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-001235</companynumb>
    <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 INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE + ETHINYLESTRADIOL 20A?G (24+4)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136596-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-000344</companynumb>
    <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>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU004D9</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 A?G, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>MENSTRUAL CYCLE MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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    </patient>
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  <safetyreport>
    <safetyreportid>7136597-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
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    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-001156</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GALLBLADDER INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE + ETHINYLESTRADIOL 20A?G (24+4)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136598-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
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    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-001150</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GALLBLADDER INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE + ETHINYLESTRADIOL 20A?G (24+4)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136600-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-001220</companynumb>
    <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 INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE + ETHINYLESTRADIOL 20A?G (24+4)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136601-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
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    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-001152</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>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136602-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
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    <companynumb>US-BAYER-2010-001151</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>GALLBLADDER INJURY</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE + ETHINYLESTRADIOL 20A?G (24+4)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136603-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-001222</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>GALLBLADDER INJURY</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE + ETHINYLESTRADIOL 20A?G (24+4)</medicinalproduct>
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    </patient>
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  <safetyreport>
    <safetyreportid>7136605-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
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      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
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      <reaction>
        <reactionmeddrapt>CHOLESTATIC LIVER INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
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        <drugdosagetext>10 MG/D, UNK</drugdosagetext>
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        <drugindication>RHINITIS ALLERGIC</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIAC</medicinalproduct>
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        <drugindication>HYPERTENSION</drugindication>
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  <safetyreport>
    <safetyreportid>7136610-0</safetyreportid>
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    <primarysource>
      <reportercountry>FRANCE</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>DENTAL DISCOMFORT</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
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        <drugindication>OSTEOPOROSIS</drugindication>
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        <drugstartdate>20090727</drugstartdate>
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    <safetyreportid>7136611-2</safetyreportid>
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      <reportercountry>COLOMBIA</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugstartdate>20100910</drugstartdate>
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        <drugenddate>20101118</drugenddate>
        <drugtreatmentduration>70</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136612-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE201011006347</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100716</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136613-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ELI_LILLY_AND_COMPANY-CA201006007640</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A662739H</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091017</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A715678H</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136614-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR201011006972</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>BLOOD CALCIUM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DEFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100604</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136615-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-ELI_LILLY_AND_COMPANY-IN201011001784</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136616-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ELI_LILLY_AND_COMPANY-AU201011005835</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100819</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136617-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE201011005992</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>COUGH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DELIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136621-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060918</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2006-31402</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136622-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060221</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2006-30994</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>
      <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>7136623-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
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    <receiptdate>20060912</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2006-31451</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>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
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  <safetyreport>
    <safetyreportid>7136624-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
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    <receiptdate>20060405</receiptdate>
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      <reportercountry>UNITED STATES</reportercountry>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
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        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
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  <safetyreport>
    <safetyreportid>7136625-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
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    <receiptdate>20060801</receiptdate>
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      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
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  <safetyreport>
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    <receiver></receiver>
    <patient>
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      <drug>
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        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
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  <safetyreport>
    <safetyreportid>7136627-6</safetyreportid>
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    <receiptdate>20061023</receiptdate>
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    <patient>
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      <drug>
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        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
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  <safetyreport>
    <safetyreportid>7136628-8</safetyreportid>
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    <patient>
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      <drug>
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    <patient>
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      <drug>
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    <safetyreportid>7136631-8</safetyreportid>
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        <reactionmeddrapt>DEATH</reactionmeddrapt>
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        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
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        <drugstartdate>20070301</drugstartdate>
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        <drugenddate>20070419</drugenddate>
        <drugtreatmentduration>49</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
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      <drug>
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        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
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        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
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        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
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        <medicinalproduct>NASACORT</medicinalproduct>
      </drug>
      <drug>
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        <medicinalproduct>DECLOMYCIN</medicinalproduct>
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      <drug>
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        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136697-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071213</receiptdate>
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    <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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071025</drugstartdate>
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  </safetyreport>
  <safetyreport>
    <safetyreportid>7136698-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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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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      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>TRANSFUSION</reactionmeddrapt>
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      <drug>
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        <drugauthorizationnumb>021290</drugauthorizationnumb>
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        <drugenddate>20071101</drugenddate>
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    <transmissiondateformat>102</transmissiondateformat>
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      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
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    <receiver></receiver>
    <patient>
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      <drug>
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        <medicinalproduct>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
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      <drug>
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        <medicinalproduct>SILDENAFIL CITRATE</medicinalproduct>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
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    <safetyreportid>7136700-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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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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      <drug>
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        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
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    <safetyreportid>7136701-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071228</receiptdate>
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      <reportercountry>UNITED STATES</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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        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
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        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061208</drugstartdate>
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        <drugtreatmentduration>361</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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    <safetyreportid>7136702-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071222</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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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>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070128</drugstartdate>
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    <safetyreportid>7136703-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070910</receiptdate>
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      <reportercountry>UNITED STATES</reportercountry>
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    <receiver></receiver>
    <patient>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
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  <safetyreport>
    <safetyreportid>7136704-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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    <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>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILOPROST INHALATION SOLUTION 2.5UG US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
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        <drugstartdate>20070919</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL CITRATE</medicinalproduct>
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    <safetyreportid>7136705-1</safetyreportid>
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    <serious>1</serious>
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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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBRISENTAN</medicinalproduct>
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    <safetyreportid>7136706-3</safetyreportid>
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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>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
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      <reaction>
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      <reportercountry>UNITED STATES</reportercountry>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>EXERCISE TOLERANCE DECREASED</reactionmeddrapt>
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      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080730</drugenddate>
        <drugtreatmentduration>917</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136711-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2007-18346</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070307</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136712-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071204</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2007-18709</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>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071202</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136713-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080227</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2007-18296</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136714-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2007-18756</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070719</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136715-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2007-28158</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136716-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080218</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2007-14718</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>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070330</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136717-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2007-18008</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>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA STAPHYLOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071201</drugenddate>
        <drugtreatmentduration>431</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136718-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061227</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2006-31470</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136719-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090617</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2007-18876</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070515</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136720-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090311</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2007-18660</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071031</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136721-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2007-18521</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>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071111</drugenddate>
        <drugtreatmentduration>727</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136724-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201041356NA</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>YAZ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136726-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-000331</companynumb>
    <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>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136737-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-PAR PHARMACEUTICAL, INC-2010SCPR002289</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugauthorizationnumb>088148</drugauthorizationnumb>
        <drugdosagetext>25 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugauthorizationnumb>088148</drugauthorizationnumb>
        <drugdosagetext>5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>051</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080505</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugauthorizationnumb>088148</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTAZIDIME</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADENOSYL METHIONINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUTATHIONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMMONIUM GLYCYRRHIZINATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TINIDAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIPERACILLIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ABDOMINAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULBACTAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ABDOMINAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPROSTADIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLASMA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYMOSIN ALPHA 1</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYMOSIN ALPHA 1</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136738-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070412</receiptdate>
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    <companynumb>US-ACTELION-A-NJ2007-31921</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136739-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
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    <companynumb>US-ACTELION-A-NJ2007-31904</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>
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        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
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        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136740-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
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    <receiptdate>20070718</receiptdate>
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      <reportercountry>UNITED STATES</reportercountry>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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      </drug>
    </patient>
  </safetyreport>
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    <receiver></receiver>
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      <drug>
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        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETERISATION CARDIAC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136798-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-19047</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>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071226</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136799-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-19343</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>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070710</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136800-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2007-31890</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136801-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080228</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-19703</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>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080110</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136802-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080303</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-19819</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>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080223</drugenddate>
        <drugtreatmentduration>332</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL CITRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136803-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080128</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-19352</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136804-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071212</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2007-31898</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136805-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090428</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-19373</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>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061206</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136806-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-19629</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>HYPERCAPNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136807-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071217</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2007-30979</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136808-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2007-30967</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136809-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100305</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-19660</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>SYNCOPE</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>7136810-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071220</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2007-30969</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136811-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2007-31923</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136812-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070816</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2007-31937</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136813-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2007-31942</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136814-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2007-30613</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136815-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070823</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2007-31465</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136816-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080404</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-19863</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070322</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTAVIS</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136817-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100408</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-19951</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>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</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>20080124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100402</drugenddate>
        <drugtreatmentduration>799</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136818-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070830</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2007-31894</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136819-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070907</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2007-31400</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136820-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2007-31896</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136821-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2007-30942</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136822-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071012</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2007-31900</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136823-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2007-31933</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136824-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090820</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-19932</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>EYE DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA BACTERIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136825-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090428</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-20091</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>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080318</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136826-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-20578</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>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136827-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-20293</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>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136828-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
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    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080513</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-20606</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETROPERITONEAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
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        <drugenddate>20080101</drugenddate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136829-9</safetyreportid>
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    <transmissiondate>20110411</transmissiondate>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-20223</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>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>EP060P0102</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080321</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136830-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-21157</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136831-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-21085</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>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
        <drugbatchnumb>64280A</drugbatchnumb>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090127</drugenddate>
        <drugtreatmentduration>239</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136832-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080708</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-21191</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>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071231</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136833-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080516</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-20632</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136834-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20081218</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-21237</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>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <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>20080429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080630</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136835-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-20710</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>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080416</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136836-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-21408</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>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136837-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090812</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-21177</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 125 MG US</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 125 MG US</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136838-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-20730</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</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>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080506</drugenddate>
        <drugtreatmentduration>90</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136839-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-21482</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>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080605</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136840-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080523</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-20714</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>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
        <drugbatchnumb>63230A</drugbatchnumb>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070911</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136841-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090401</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-21517</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</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>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 125 MG US</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 125 MG US</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080813</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLURBIPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136842-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070813</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2007-31897</companynumb>
    <primarysource>
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    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090522</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-21589</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>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE FOR UNAPPROVED INDICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 62.5 MG US</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136872-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080606</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-28372</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136873-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080808</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-21645</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>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080519</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136874-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080821</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-21656</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080708</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136875-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100312</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-21692</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>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136876-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080814</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-21632</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>TRACLEER</medicinalproduct>
        <drugbatchnumb>63228A</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040311</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTAVIS</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080418</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136877-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-28086</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136878-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080618</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-28109</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080617</drugenddate>
        <drugtreatmentduration>120</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136879-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080829</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-28208</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136880-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080708</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-28365</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136881-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080816</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-21613</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>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
        <drugbatchnumb>63227A</drugbatchnumb>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBRISENTAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136882-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090429</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-21934</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>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060306</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136883-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20081125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-21927</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILOPROST INHALATION SOLUTION 5UG US</medicinalproduct>
        <drugbatchnumb>64280A</drugbatchnumb>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>5 UG, UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136884-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20081118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-28230</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081024</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136885-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100329</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-21972</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>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
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        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061208</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061207</drugenddate>
        <drugtreatmentduration>763</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136886-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-22067</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>INSOMNIA</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>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG QAM + 62.5 MG QPM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136887-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100217</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-23204</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>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080916</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136888-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20081020</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-22520</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>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILOPROST INHALATION SOLUTION 5UG US</medicinalproduct>
        <drugbatchnumb>62225A</drugbatchnumb>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>5 UG, UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060814</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136889-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-23300</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK COMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 125 MG US</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136890-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080924</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-22090</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080919</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136891-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090415</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-22752</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080904</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136892-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080925</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-28199</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080902</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136893-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20081129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-28193</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136894-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091217</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-22131</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>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061023</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136895-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20081124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-22983</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>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041223</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136896-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20081209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-23051</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136897-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20081002</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-28306</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136898-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-22222</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</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>20080301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136899-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20081217</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-28159</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136900-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090303</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-21892</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE FOR UNAPPROVED INDICATION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
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      <drug>
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      <drug>
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        <medicinalproduct>COUMADIN</medicinalproduct>
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    <safetyreportid>7136901-3</safetyreportid>
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    <receiver></receiver>
    <patient>
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  <safetyreport>
    <safetyreportid>7136939-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-23328</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>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
        <drugbatchnumb>64276A</drugbatchnumb>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081228</drugenddate>
        <drugtreatmentduration>198</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136940-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100302</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-24016</companynumb>
    <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 SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 125 MG US</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136941-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090228</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-24260</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090226</drugenddate>
        <drugtreatmentduration>1534</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136942-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090702</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-25374</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>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136943-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090226</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-24116</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>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090226</drugenddate>
        <drugtreatmentduration>83</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136944-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-23474</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>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
        <drugbatchnumb>64272A</drugbatchnumb>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080423</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136945-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-23485</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090109</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136946-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090518</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-25398</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136947-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-24149</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</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>20081218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091224</drugenddate>
        <drugtreatmentduration>371</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136948-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090520</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-25542</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>ILOPROST INHALATION SOLUTION 5UG US</medicinalproduct>
        <drugbatchnumb>74337A</drugbatchnumb>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>5 UG, 7 INHALATIONS PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBRISENTAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136949-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20081201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-28472</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136950-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090309</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-24452</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>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
        <drugbatchnumb>64274A</drugbatchnumb>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
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        <drugstartdate>20080826</drugstartdate>
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        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136951-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090610</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-23647</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugauthorizationnumb>021290</drugauthorizationnumb>
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        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
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        <drugstartdate>20071005</drugstartdate>
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  <safetyreport>
    <safetyreportid>7136952-9</safetyreportid>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090729</receiptdate>
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    <companynumb>US-ACTELION-A-NJ2009-24461</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 125 MG US</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136953-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <receiptdate>20090521</receiptdate>
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    <companynumb>US-ACTELION-A-NJ2009-23723</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
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    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID OVERLOAD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERIAL HYPERTENSION</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>7136954-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090204</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-23877</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>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
        <drugbatchnumb>64280A</drugbatchnumb>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090126</drugenddate>
        <drugtreatmentduration>236</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136955-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100913</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-24103</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>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</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>20070511</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136956-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20081119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-31930</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136957-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090715</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-24468</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>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID OVERLOAD</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136958-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090420</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-24893</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>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090301</drugenddate>
        <drugtreatmentduration>382</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136961-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090415</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-CELGENEUS-056-21880-10110934</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>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090115</drugenddate>
        <drugtreatmentduration>245</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136962-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090903</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-CELGENEUS-056-21880-10082149</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090318</drugenddate>
        <drugtreatmentduration>362</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DISULONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPERGIC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAHOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAREG</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERELIT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALACYCLOVIR HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136969-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100910</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-013910-10</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>DRUG ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DELSYM</medicinalproduct>
        <drugbatchnumb>50826</drugbatchnumb>
        <drugdosagetext>PATIENT DRANK ENTIRE BOTTLE.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136970-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090903</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-CELGENEUS-056-21880-10082095</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>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136971-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10090128</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100818</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136977-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041014</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2003-03145</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIGHT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET UNKNOWN MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030723</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136978-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2003-03325</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</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>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET UNKNOWN MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060113</drugenddate>
        <drugtreatmentduration>952</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136979-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2003-03524</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>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136980-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051011</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2004-04274</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>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET UNKNOWN MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136981-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060603</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2003-02654</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>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030203</drugenddate>
        <drugtreatmentduration>18</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>20030204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
        <drugdosagetext>15 MG, QPM</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
        <drugdosagetext>20 MEQ, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugdosagetext>3.125 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILRINONE</medicinalproduct>
        <drugdosagetext>.5 KG, PER MIN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugdosagetext>160 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
        <drugdosagetext>10 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVIT</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136982-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10100847</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 FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071126</drugenddate>
        <drugtreatmentduration>253</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100928</drugenddate>
        <drugtreatmentduration>253</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136983-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2004-07229</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>DEATH</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>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136984-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090424</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-28194</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090405</drugenddate>
        <drugtreatmentduration>523</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136985-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030902</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2003-02371</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>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <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>20021229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030129</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugdosagetext>80 UNK, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136986-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090511</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-25690</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>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
        <drugbatchnumb>74339A</drugbatchnumb>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090507</drugenddate>
        <drugtreatmentduration>147</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136987-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ACTELION-A-US2004-08278</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136988-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090511</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-28404</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081027</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136989-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-28281</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081003</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7136990-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090522</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-28113</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
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      <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>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040720</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040719</drugenddate>
        <drugtreatmentduration>17</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>20031229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040127</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>3 MG, QOD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040428</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>4.5 MG, QOD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>20 MEQ, 3 TABS QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>20 MEQ, 2 1/2 TABS QD</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE</medicinalproduct>
        <drugdosagetext>UNK, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
        <drugdosagetext>4 L, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugdosagetext>35 MG, Q1WEEK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137014-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090430</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-27970</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <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>7137015-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090430</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-28146</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137016-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090611</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-25836</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>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
        <drugbatchnumb>74339A</drugbatchnumb>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>EP056P0101</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070308</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137017-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090716</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-28114</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090613</drugenddate>
        <drugtreatmentduration>1054</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137018-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2005-09364</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>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 62.5 MG US</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>31.25 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>414</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137019-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050824</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2005-09451</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>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET UNKNOWN MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137020-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020319</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2002-00086</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82.54</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <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>20020207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020319</drugenddate>
        <drugtreatmentduration>40</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>500 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugdosagetext>40 MG, Q1WEEK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR</medicinalproduct>
        <drugdosagetext>10 MEQ, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugdosagetext>30 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTIMMUNE</medicinalproduct>
        <drugdosagetext>1 CC, Q3WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137021-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090527</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-27049</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080728</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137022-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2005-08585</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 125 MG US</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 125 MG US</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137023-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090413</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-28378</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>
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      <drug>
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        <medicinalproduct>REVATIO</medicinalproduct>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2005-11314</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>BOSENTAN TABLET 62.5 MG US</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137040-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-28432</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>BOSENTAN TABLET UNKNOWN MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137041-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090226</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-28161</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137042-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080218</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2006-11917</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>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET UNKNOWN MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050523</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137043-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070220</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2005-10028</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050516</drugenddate>
        <drugtreatmentduration>174</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137044-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080912</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20071201993</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FINIBAX</medicinalproduct>
        <drugauthorizationnumb>022106</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KN-3B</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>DEHYDRATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KN-3B</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KN-3B</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KN-3B</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMEDIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEISHOKU</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEISHOKU</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DALACIN-S</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137045-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090216</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-28043</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137046-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060607</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2006-12024</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051222</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137047-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090306</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-30958</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137048-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090305</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-28098</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137049-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090306</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-27340</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137050-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090312</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-28370</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137051-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090311</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-28484</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090309</drugenddate>
        <drugtreatmentduration>612</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>7137052-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090310</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-28205</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081113</drugstartdate>
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        <drugenddate>20090310</drugenddate>
        <drugtreatmentduration>117</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137053-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
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    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090313</receiptdate>
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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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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
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      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137054-8</safetyreportid>
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    <transmissiondate>20110411</transmissiondate>
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    <receiptdate>20090316</receiptdate>
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    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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      </drug>
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    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090708</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBRISENTAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137072-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090910</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-27449</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090902</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137073-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-CELGENEUS-062-21880-10080308</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN WARM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100802</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100818</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100721</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAVANIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTI-INFECTIVE THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100722</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTRIM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEXANE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100715</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100726</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137074-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-26552</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>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
        <drugbatchnumb>74346A</drugbatchnumb>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090723</drugenddate>
        <drugtreatmentduration>85</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137075-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090911</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-27463</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080818</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137076-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090318</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-28324</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090317</drugenddate>
        <drugtreatmentduration>291</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137077-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090402</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-28213</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137078-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090818</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-27003</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>74349A</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080925</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137079-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-27872</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090817</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMODULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137080-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091001</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-27202</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>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
        <drugbatchnumb>74349A</drugbatchnumb>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090820</drugenddate>
        <drugtreatmentduration>217</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>EP059P0101</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080911</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137081-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-27490</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>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061211</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137082-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
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    <receiptdateformat>102</receiptdateformat>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-27454</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090818</drugenddate>
        <drugtreatmentduration>421</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137083-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091013</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-28077</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091012</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137084-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091013</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-28090</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137085-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091013</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-27292</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090904</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137086-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091021</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-28477</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091016</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137087-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2005-15273</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILOPROST INHALATION SOLUTION 5UG US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>5 UG, 6 X DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNICAP-M</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137088-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080414</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2005-15269</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILOPROST INHALATION SOLUTION 5UG US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>5 UG, 6 X DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERELAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUMATRIPTAN SUCCINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137089-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091224</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-28092</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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 125 MG US</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 125 MG US</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 125 MG US</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 125 MG US</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TADALAFIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137090-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-CELGENEUS-151-C5013-10100613</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE HEART DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLASMA CELL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC INFLAMMATORY RESPONSE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CC-5013</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101011</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100919</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANADOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERENTEROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS HCT</medicinalproduct>
        <drugdosagetext>80/25 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS HCT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOMYOPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOMYOPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOMYOPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOMYOPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLMUCOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCTIVE COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101007</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KONAKION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAGMIN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>OSTEOLYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS</medicinalproduct>
        <drugdosagetext>2 UNITS</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS</medicinalproduct>
        <drugdosagetext>2 UNITS</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRALEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HARPAGOMED</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPTIFEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLECTOR</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRFEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137093-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AMGEN-DEUSP2010000675</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PARATHYROID HORMONE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLIA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>OSTEOPOROSIS POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100813</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE STADA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALINOR                            /00031402/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINKAMIN-FALK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEXANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRYASOL CODEIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEPILTA                            /00115701/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITARENAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLSPASMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI PHOSPHAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFORTIL PLUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BICANORM                           /00049401/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOL                          /00661201/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVAMINSULFON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENVELA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137094-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-12145BP</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.19</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020850</drugauthorizationnumb>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137104-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100825</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20101200632</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 PRESCRIBING ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUROTEP MT</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONALON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONEALFA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELDEST</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLURBIPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137105-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20101201186</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>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG PRESCRIBING ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUROTEP MT</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALONAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALONAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEXITIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUROTROPIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUROTROPIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUROTROPIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLURBIPROFEN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLURBIPROFEN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEXITIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEO VITACAIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEO VITACAIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROPIVACAINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROPIVACAINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137106-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20101201167</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG PRESCRIBING ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUROTEP MT PATCH</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUROTEP MT PATCH</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUROTEP MT PATCH</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUROTEP MT PATCH</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAI KENCHU TO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGLAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAXOBERON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIMATIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZALIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KELNAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIN OD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLURBIPROFEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUROTROPIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POSTERISAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSCOPAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DORAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOHRUS TAPE</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALONAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYSLEE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUROTROPIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACONINSUN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137107-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AMGEN-DEUSP2010005276</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLIA</medicinalproduct>
        <drugdosagetext>UNK UNK, ONE TIME DOSE</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090512</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137108-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090420</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2006-16861</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILOPROST INHALATION SOLUTION 2.5UG US</medicinalproduct>
        <drugbatchnumb>63228A</drugbatchnumb>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>2.5 UG, 4 X DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTIGALL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NADOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137110-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2006-12653</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060322</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137111-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2006-13399</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACUTE SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENERGY INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 62.5 MG US</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137112-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080327</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2006-16147</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>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILOPROST INHALATION SOLUTION 5UG US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>5 UG, 6 X DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070717</drugenddate>
        <drugtreatmentduration>572</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIAZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZAROXOLYN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
        <drugtreatmentduration>55</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137113-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070307</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2006-14524</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILOPROST INHALATION SOLUTION 5UG US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>5 UG, 6-X A DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILOPROST INHALATION SOLUTION 5UG US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>2.5 UG, SINGLE</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060224</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTIMMUNE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137114-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090316</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2006-13473</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137115-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080910</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2006-12873</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET UNKNOWN MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTAVIS</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080821</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137116-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2006-16126</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>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILOPROST INHALATION SOLUTION 5UG US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>5 UG, 6-9 X DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070728</drugenddate>
        <drugtreatmentduration>390</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137117-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2006-12980</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 62.5 MG US</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060809</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137118-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070402</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2006-14843</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>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILOPROST INHALATION SOLUTION 5UG US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>5 UG, 5-6 X DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070327</drugenddate>
        <drugtreatmentduration>313</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILOPROST INHALATION SOLUTION 5UG US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>2.5 UG, SINGLE</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060518</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070327</drugenddate>
        <drugtreatmentduration>312</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137119-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091218</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2006-16166</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILOPROST INHALATION SOLUTION 5UG US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>5 UG, 6-9 X DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOLAZONE</medicinalproduct>
        <drugdosagetext>5 MG, QOD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENAZEPRIL</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE W/SALBUTAMOL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137120-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070509</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2006-15664</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILOPROST INHALATION SOLUTION 5UG US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>5 UG, 6 X DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070509</drugenddate>
        <drugtreatmentduration>253</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOMYCIN SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPHYTON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XIFAXAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAILY MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILYBUM MARIANUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE SULFATE W/CHONDROITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL PM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GARLIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137121-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2006-12745</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>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET UNKNOWN MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137126-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070831</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-15367</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>ILOPROST INHALATION SOLUTION 5UG US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>5 UG, 6-9 X DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070427</drugenddate>
        <drugtreatmentduration>80</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVOXAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETOPTIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZOPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEFLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137127-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100330</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-15507</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 125 MG US</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070716</drugenddate>
        <drugtreatmentduration>180</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 125 MG US</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 125 MG US</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>10 G, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugdosagetext>20 G, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137128-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090505</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ACTELION-A-US2007-15468</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>BOSENTAN TABLET 125 MG CD</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137129-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-16437</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137130-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070601</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-16299</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILOPROST INHALATION SOLUTION 5UG US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>5 UG, 6XDAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070509</drugenddate>
        <drugtreatmentduration>490</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137131-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070423</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-15568</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>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILOPROST INHALATION SOLUTION 5UG US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>5 UG, 4-6 X DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070423</drugenddate>
        <drugtreatmentduration>536</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENICILLIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137133-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090923</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-16331</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTAVIS</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137135-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070529</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-16297</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>ILOPROST INHALATION SOLUTION 5UG US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>5 UG, 6 X DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>COR PULMONALE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070326</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOXAFIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137136-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080917</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-15770</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>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070119</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137137-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070423</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-15578</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>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILOPROST INHALATION SOLUTION 5UG US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>5 UG, 6-9 X DAY</drugdosagetext>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070407</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILOPROST INHALATION SOLUTION 5UG US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>5 UG, 4 X DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070422</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITEK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137138-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070525</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ACTELION-A-US2007-15914</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>BOSENTAN TABLET 62.5 MG CD</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137139-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070604</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ACTELION-A-US2007-16080</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>BOSENTAN TABLET 125 MG CD</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137140-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070424</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-15194</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>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FUNCTION TEST DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILOPROST INHALATION SOLUTION 5UG US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>5 UG, 6 X DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070421</drugenddate>
        <drugtreatmentduration>249</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137141-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080624</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-16234</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>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137142-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090902</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-16129</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>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>63227A EPO60P0102</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTAVIS</medicinalproduct>
        <drugbatchnumb>83392A</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137143-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20101201193</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG PRESCRIBING ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUROTEP MT PATCH</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPAND</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPODOWN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAUZELIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGLAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOSENN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROPIVACAINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOCAIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137144-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20101108890</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>AIB3000</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>AIB3000</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137145-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101201171</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>9.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEREOTYPY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugauthorizationnumb>015923</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DELIRIUM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137146-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2006-13573</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050706</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137147-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061212</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ACTELION-A-US2006-13858</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>BOSENTAN TABLET 125 MG CD</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137148-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080917</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2006-13606</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137149-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080221</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2006-13645</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED UPPER AIRWAY SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080116</drugenddate>
        <drugtreatmentduration>1892</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137150-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-14242</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILOPROST INHALATION SOLUTION 5UG US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>5 UG, 6 X /D</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070627</drugenddate>
        <drugtreatmentduration>197</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILOPROST INHALATION SOLUTION 5UG US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>2.5 UG, SINGLE</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugdosagetext>62.5 MG, OD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070612</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITEK</medicinalproduct>
        <drugdosagetext>125 MG/KG, OD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40 MG, OD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugdosagetext>125 MEQ, OD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugdosagetext>100 G, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugdosagetext>20 MG, QPM</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>150 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
        <drugdosagetext>6 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugdosagetext>25 MG, OD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070612</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
        <drugdosagetext>20 UG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>5 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070226</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137151-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2006-13662</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>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137152-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20081119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2006-13874</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061201</drugenddate>
        <drugtreatmentduration>308</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137153-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2006-15169</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>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILOPROST INHALATION SOLUTION 5UG US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>5 UG, 6-9 X DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
        <drugtreatmentduration>412</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137154-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080508</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2006-13667</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>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET UNKNOWN MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137155-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ACTELION-A-US2006-13684</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>BOSENTAN TABLET 125 MG CD</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137156-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20081126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ACTELION-A-US2006-13929</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 62.5 MG CD</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061209</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137157-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080425</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2006-13734</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>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080401</drugenddate>
        <drugtreatmentduration>832</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137158-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070914</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2006-16652</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLUNTED AFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILOPROST INHALATION SOLUTION 5UG US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>5 UG, 7 X DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070914</drugenddate>
        <drugtreatmentduration>333</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137159-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061211</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2006-13872</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137160-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080131</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2006-13486</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN CONSUMPTION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137161-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2006-13834</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>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061027</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137162-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-14294</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILOPROST INHALATION SOLUTION 5UG US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>5 UG, 6-9 X /DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070203</drugenddate>
        <drugtreatmentduration>165</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137163-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ACTELION-A-US2007-13991</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>BOSENTAN TABLET 62.5 MG CD</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137164-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090807</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-15192</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>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061120</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137165-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070320</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ACTELION-A-US2007-14648</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>BOSENTAN TABLET 125 MG CD</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125. MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137166-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2006-14367</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>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILOPROST INHALATION SOLUTION 2.5UG US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>2.5 UG, 6 X DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061218</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILOPROST INHALATION SOLUTION 2.5UG US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>5 UG, 6-9 X DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061217</drugenddate>
        <drugtreatmentduration>37</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL</medicinalproduct>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137167-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-14255</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>ILOPROST INHALATION SOLUTION 5UG US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>5 UG, 6-9 X DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070119</drugenddate>
        <drugtreatmentduration>92</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XIFAXAN</medicinalproduct>
        <drugindication>DIARRHOEA INFECTIOUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070119</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137169-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070316</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-14664</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>ILOPROST INHALATION SOLUTION 5UG US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>5 UG, 5 X DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>COR PULMONALE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070221</drugenddate>
        <drugtreatmentduration>301</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HECTOROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137170-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-14626</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</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>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137171-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ACTELION-A-US2007-14271</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 125 MG CD</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137172-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070327</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ACTELION-A-US2007-14734</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 125 MG CD</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137173-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070221</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-14338</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060713</drugstartdate>
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  <safetyreport>
    <safetyreportid>7137174-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20081008</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-14478</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071017</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137175-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070306</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-14532</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>ILOPROST INHALATION SOLUTION 5UG US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>5 UG, 5-6 X DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070304</drugenddate>
        <drugtreatmentduration>523</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM SILVER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137176-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080701</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-14780</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>SKIN ODOUR ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137177-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070312</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ACTELION-A-US2007-14525</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>BOSENTAN TABLET 62.5 MG CD</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137178-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ACTELION-A-US2007-14998</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 125 MG CD</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137179-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070330</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ACTELION-A-US2007-14800</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>BOSENTAN TABLET 62.5 MG CD</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137180-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070831</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-13944</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>APPENDICITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050803</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137181-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090808</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-14866</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABSCESS LIMB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060627</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137182-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070308</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-14598</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137183-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070315</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-14688</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>ILOPROST INHALATION SOLUTION 5UG US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>5 UG, 6-9 X DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070312</drugenddate>
        <drugtreatmentduration>159</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUONEB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137184-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
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    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
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    <receiptdate>20070409</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ACTELION-A-US2007-14957</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>BOSENTAN TABLET 62.5 MG CD</medicinalproduct>
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        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137185-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
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    <receiptdate>20070802</receiptdate>
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    <companynumb>US-ACTELION-A-US2007-17267</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137186-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070705</receiptdate>
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    <companynumb>US-ACTELION-A-US2007-16810</companynumb>
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      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070529</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137187-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
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    <seriousnessdeath>1</seriousnessdeath>
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    <receiptdate>20070703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 62.5 MG CD</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>7137188-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
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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>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILOPROST INHALATION SOLUTION 5UG US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>5 UG, 6-9 X DAY</drugdosagetext>
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        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070221</drugstartdate>
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        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXCEDRIN (MIGRAINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137189-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-17342</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 125 MG US</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090711</drugenddate>
        <drugtreatmentduration>842</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 125 MG US</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137190-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070813</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-16927</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>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILOPROST INHALATION SOLUTION 5UG US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>5 UG, 6-9 X DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070711</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOROXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137191-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-16925</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>ILOPROST INHALATION SOLUTION 5UG US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>5 UG, 6-9 X DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070623</drugenddate>
        <drugtreatmentduration>226</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137193-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ACTELION-A-US2007-16957</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>BOSENTAN TABLET 125 MG CD</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137194-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ACTELION-A-US2007-16994</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>BOSENTAN TABLET 62.5 MG CD</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>6.25 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137195-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-16979</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>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN CONSUMPTION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060906</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137196-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-16347</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091123</drugenddate>
        <drugtreatmentduration>1652</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137197-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-16982</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WALKING DISABILITY</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>7137198-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-17185</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>ILOPROST INHALATION SOLUTION 5UG US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>5 UG, 6-9X DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070724</drugenddate>
        <drugtreatmentduration>406</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZAROXOLYN</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40 G, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR</medicinalproduct>
        <drugdosagetext>20 MEQ, CONT INFUS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
        <drugdosagetext>500 MG, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>2 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugdosagetext>UNK, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugdosagetext>.4 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugdosagetext>7.5 MG, QD</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137200-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-17188</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137201-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070816</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ACTELION-A-US2007-17447</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>BOSENTAN TABLET 125 MG CD</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137202-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080715</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-18035</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137203-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-17500</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>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CONTRACTIONS INVOLUNTARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>UNK UG, UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
        <drugbatchnumb>63227A,63230A, 64279A</drugbatchnumb>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>UNK UG, UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137204-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090420</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-17573</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>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070705</drugenddate>
        <drugtreatmentduration>57</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070330</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137205-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070918</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ACTELION-A-US2007-17767</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>BOSENTAN TABLET 125 MG US</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137206-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080910</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-18037</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137207-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070917</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-17768</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070821</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137208-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100330</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-18042</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC PACEMAKER INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 125 MG US</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137209-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070920</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-17840</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137210-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071226</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-18134</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>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070830</drugenddate>
        <drugtreatmentduration>69</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137211-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080924</receiptdate>
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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>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
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        <drugstartdate>20030201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
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  <safetyreport>
    <safetyreportid>7137212-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071012</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-18136</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>
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        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137213-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090102</receiptdate>
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    <companynumb>US-ACTELION-A-US2007-18103</companynumb>
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      <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>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
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    </patient>
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  <safetyreport>
    <safetyreportid>7137214-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
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    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 125 MG CD</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
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        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>7137215-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
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    <seriousnessdeath>1</seriousnessdeath>
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      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugstartdate>20060207</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTAVIS</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137216-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2006-16340</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>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIGHT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILOPROST INHALATION SOLUTION 5UG US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>5 UG, 6 X DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060810</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NPH INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOLAZONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERSANTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBRISENTAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137217-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071120</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-17943</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMODULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137218-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070822</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-17478</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>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070821</drugenddate>
        <drugtreatmentduration>131</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040809</drugenddate>
        <drugtreatmentduration>278</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137219-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100419</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-18033</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BRAIN OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 125 MG US</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMODULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137220-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080611</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2006-15936</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILOPROST INHALATION SOLUTION 5UG US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>5 UG, 5 X DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070918</drugenddate>
        <drugtreatmentduration>656</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070918</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137221-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010007329</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>PROCRIT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137225-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-JNJFOC-20101108225</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137226-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20100400963</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACTINIC KERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS CONTACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION ATRIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>QRS AXIS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SJOGREN'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL COLD MULTI-SYMPTOM DAYTIME COOL BURST</medicinalproduct>
        <drugindication>NASOPHARYNGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL COLD MULTI-SYMPTOM NIGHTTIME COOL BURST</medicinalproduct>
        <drugindication>NASOPHARYNGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137227-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101006553</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BARRETT'S OESOPHAGUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugauthorizationnumb>017463</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137228-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101108206</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRODUCT ADHESION ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
        <drugbatchnumb>0902405</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137229-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20101108657</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUROTEP MT</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137230-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101104450</companynumb>
    <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 PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INADEQUATE ANALGESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT ADHESION ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0911491;0914196</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0911491;0914196</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL EXTENDED-RELEASE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137231-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-JNJFOC-20100103903</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL FIELD DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CILEST</medicinalproduct>
        <drugauthorizationnumb>019653</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137232-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-JNJFOC-20101108219</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>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugdosagetext>HALF OF 12.5UG/HR PATCH</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137233-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20101108676</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>DUROTEP MT</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137234-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20101108823</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>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUROTEP MT</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137235-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10111584</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137241-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-18190</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137242-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10111313</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091229</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugdosagetext>5MG-10MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101109</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137243-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-US-EMD SERONO, INC.-7029503</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137244-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-US-EMD SERONO, INC.-7029875</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHIECTASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030103</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137245-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-US-EMD SERONO, INC.-7029765</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>REBIF</medicinalproduct>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101103</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137246-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-US-EMD SERONO, INC.-7029277</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</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137247-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-US-EMD SERONO, INC.-7029787</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>OESOPHAGEAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMYTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ICTUX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137248-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-US-EMD SERONO, INC.-7029332</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAMPYLOBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPOATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAFALGAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTAZOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANXILIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUBRUFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137249-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-US-EMD SERONO, INC.-7029490</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL ACHALASIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100828</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100830</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137250-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-US-EMD SERONO, INC.-7029767</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137251-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071218</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-18456</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>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137252-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20081107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-18168</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>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070514</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137253-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-27929</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137254-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090310</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-18387</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>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080107</drugenddate>
        <drugtreatmentduration>647</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTAVIS</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071218</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137255-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080624</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-18401</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>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137256-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091231</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-18481</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137257-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070416</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-18326</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070227</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137258-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20081202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-18609</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>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070906</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137259-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-18520</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>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137260-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010KR79714</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</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>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090206</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137261-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2009US02577</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACTINOMYCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMORAL NECK FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEQUESTRECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>90 MG, QMO</drugdosagetext>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugdosagetext>90 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137262-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2009AU25279</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PSYCHIATRIC SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY CESSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>900 MG /DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040714</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>900 MG DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>12.5 MG,DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>50 MG DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090625</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137264-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR80170</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>
      <reaction>
        <reactionmeddrapt>INTERNAL FIXATION OF FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB PROSTHESIS USER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TIBIA FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugbatchnumb>UNK.</drugbatchnumb>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137265-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080512</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-18749</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>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137266-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2008-19050</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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080517</drugenddate>
        <drugtreatmentduration>176</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137267-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-18934</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>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTAVIS</medicinalproduct>
        <drugbatchnumb>74337A</drugbatchnumb>
        <drugdosagetext>UNK UG, UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081031</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137269-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ACTELION-A-US2007-18784</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>BOSENTAN TABLET 125 MG CD</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137270-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080708</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2008-21184</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>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080719</drugenddate>
        <drugtreatmentduration>41</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137271-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071211</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ACTELION-A-US2007-18816</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>BOSENTAN TABLET 125 MG CD</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137272-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ACTELION-A-US2007-18782</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>BOSENTAN TABLET 125 MG CD</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137273-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090401</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-18813</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</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>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071027</drugenddate>
        <drugtreatmentduration>234</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080131</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137274-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071212</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-18837</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>COAGULATION TIME SHORTENED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071127</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137275-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071217</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ACTELION-A-US2007-18891</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>BOSENTAN TABLET 125 MG CD</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137276-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071217</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ACTELION-A-US2007-18872</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>BOSENTAN TABLET 62.5 MG CD</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137277-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2008-21213</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>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080327</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137278-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20081006</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2008-22225</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
        <drugbatchnumb>64280A</drugbatchnumb>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137279-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20081006</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2008-22234</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>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051214</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137280-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20081208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2008-22295</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>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080422</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137281-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20081006</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2008-22370</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>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080303</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137282-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR80577</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugbatchnumb>UNK.</drugbatchnumb>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>160 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137283-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA72627</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE SPASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137284-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010PT77823</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>20 MG, QW</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEFLAZACORT</medicinalproduct>
        <drugdosagetext>6 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>30 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>10 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugdosagetext>500 MG TWICE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE W/COLECALCIFEROL</medicinalproduct>
        <drugdosagetext>1250MG+400IU TWICE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137285-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010NL79005</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TASIGNA</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>2DD 200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TASIGNA</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>1DD 200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137286-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US75483</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1125 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON OVERLOAD</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101104</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137287-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2008-19106</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137288-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2008-19226</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070604</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137295-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080922</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2007-18748</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
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      <reaction>
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  <safetyreport>
    <safetyreportid>7137311-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080903</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2008-21777</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137312-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080902</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2008-21765</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137313-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20081009</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2008-22318</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>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070906</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137314-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2008-21255</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>ILOPROST INHALATION SOLUTION 5UG US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>UNK UG, UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080617</drugenddate>
        <drugtreatmentduration>1139</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137315-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080910</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2008-21922</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137317-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010AR64541</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APTYALISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL RECESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137318-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US79460</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137319-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010KR79715</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>RECTAL CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091218</drugenddate>
        <drugtreatmentduration>229</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137320-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010KR80050</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</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>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100818</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137321-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR80487</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>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137322-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US54929</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 CHLORIDE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugindication>OSTEOPOROSIS POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugdosagetext>7.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOMEL</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PARATHYROID HORMONE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>400 UNITS DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137323-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010MX80567</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>160 MG, ONE TABLET, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137324-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US79458</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TRANSFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137325-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA75193</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IDIOPATHIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091217</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137326-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010PL76870</companynumb>
    <primarysource>
      <reportercountry>POLAND</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>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050574</drugauthorizationnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137327-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA79719</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SPINAL CORD COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100210</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137328-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010VE76179</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION RATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG/ YEAR</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>ONCE  A DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugdosagetext>ONE A DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137329-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10112730</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>CATHETER SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137330-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2008-19173</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL CITRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137331-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080909</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2008-19317</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>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030918</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTAVIS</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137332-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080114</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2008-19150</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>FLUID OVERLOAD</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
        <drugtreatmentduration>1139</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTAVIS</medicinalproduct>
        <drugdosagetext>5 UG, 6XDAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
        <drugtreatmentduration>580</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137333-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080715</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2008-19319</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137334-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2008-19361</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>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060925</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137335-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20081113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ACTELION-A-US2008-19509</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 62.5 MG CD</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137336-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2008-19397</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>ILOPROST INHALATION SOLUTION 5UG US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080116</drugenddate>
        <drugtreatmentduration>90</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137337-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20081007</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2008-19071</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>DEPRESSION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071212</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTAVIS</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080601</drugstartdate>
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        <drugtreatmentduration>111</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
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    </patient>
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  <safetyreport>
    <safetyreportid>7137338-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <seriousnessdeath>1</seriousnessdeath>
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    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
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      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 125 MG CD</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
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  <safetyreport>
    <safetyreportid>7137339-5</safetyreportid>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20081121</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2008-22824</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071112</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137355-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080313</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ACTELION-A-US2008-19839</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>BOSENTAN TABLET 125 MG CD</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137356-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2008-20549</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>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 125 MG US</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 125 MG US</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137357-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20081205</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2008-23025</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>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
        <drugbatchnumb>64277A</drugbatchnumb>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBRISENTAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137358-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080522</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2008-27911</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137359-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090528</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2008-23145</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>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137360-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100405</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2008-22585</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>HEPATIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED TENDENCY TO BRUISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED UPPER AIRWAY SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</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>7137361-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080205</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2008-19599</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>ILOPROST INHALATION SOLUTION 5UG US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>UNK UG, UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL</medicinalproduct>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137362-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20081120</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2008-22936</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>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137363-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100329</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2008-20248</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIGHT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>UNK UG, UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080205</drugenddate>
        <drugtreatmentduration>568</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137364-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2010GB04311</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100903</drugenddate>
        <drugtreatmentduration>117</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137365-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR80569</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 DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugbatchnumb>UNK.</drugbatchnumb>
        <drugdosagetext>320/12.5 MG, UNK</drugdosagetext>
        <drugindication>BLOOD PRESSURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101026</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RASILEZ</medicinalproduct>
        <drugbatchnumb>UNK.</drugbatchnumb>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLOOD PRESSURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101029</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVIAL</medicinalproduct>
        <drugdosagetext>1 TABLET A DAY</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137366-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010FI80294</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
      <qualification>3</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>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137367-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010IN80033</companynumb>
    <primarysource>
      <reportercountry>INDIA</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>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5MG/100ML</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137368-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080401</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ACTELION-A-US2008-20080</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>BOSENTAN TABLET 62.5 MG CD</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137369-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR80564</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE AND VALSARTAN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021990</drugauthorizationnumb>
        <drugdosagetext>160/5MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137370-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US80031</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS DIAPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>APLASTIC ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD TRANSFUSION, AUXILIARY PRODUCTS</medicinalproduct>
        <drugdosagetext>EVERY 4 WEEKS</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137371-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080522</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2008-20706</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>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137372-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2010GB05070</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>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT CANCER</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>20050227</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137373-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2009JP01653</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC ALLOGRAFT NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY TOXIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DECOMPOSITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DEHISCENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DRAINAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND SECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CERTICAN</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>0.75 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100523</drugenddate>
        <drugtreatmentduration>537</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CERTICAN</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>3.0 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>400 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081207</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>350 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081208</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>325 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081209</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>300 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081218</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>250 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081226</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>225 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090104</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>200 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090329</drugenddate>
        <drugtreatmentduration>84</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>150 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090330</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100808</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BAKTAR</medicinalproduct>
        <drugdosagetext>1DF</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090330</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALIZON</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTECADIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMULECT</medicinalproduct>
        <drugdosagetext>20 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081202</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMULECT</medicinalproduct>
        <drugdosagetext>20 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081206</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>50 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>10 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISODINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137375-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CH80292</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JAW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugdosagetext>2 ORAL ADMINISTRATIONS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137376-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080604</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2008-22476</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080516</drugenddate>
        <drugtreatmentduration>854</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137377-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US80000</companynumb>
    <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>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION TREATMENT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137378-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010VE80279</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</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>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANALGESICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137379-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2009US11010</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>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRAPEX ^PHARMACIA + UPJOHN^</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENICILLIN VK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137380-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2009TW60890</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE SUBCUTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>200 MG UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090305</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137381-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20081125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2008-22663</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>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081124</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137382-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090610</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2008-22700</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137383-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010VE80208</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</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>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137384-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080327</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2008-20041</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>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080226</drugenddate>
        <drugtreatmentduration>162</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080303</drugenddate>
        <drugtreatmentduration>327</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137385-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090803</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2008-22644</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>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMODULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137386-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20081230</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ACTELION-A-US2008-23258</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>BOSENTAN TABLET 125 MG CD</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137387-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20081219</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ACTELION-A-US2008-23180</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>BOSENTAN TABLET 62.5 MG CD</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137388-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090211</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2008-19759</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>TOOTH DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
        <drugbatchnumb>64276A</drugbatchnumb>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137389-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080506</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2008-20544</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>ILOPROST INHALATION SOLUTION 5UG US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080327</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080415</drugenddate>
        <drugtreatmentduration>617</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137390-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
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    <receiptdate>20091020</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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    <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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137391-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080603</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ACTELION-A-US2008-20798</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>BOSENTAN TABLET 125 MG US</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137392-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090422</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2008-23098</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081114</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137393-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
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    <receiptdate>20080306</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2008-19774</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137394-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20081015</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2008-22698</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>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
        <drugbatchnumb>1142720</drugbatchnumb>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080527</drugenddate>
        <drugtreatmentduration>179</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137396-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20081231</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2008-23290</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137397-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2008-19939</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>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DARK CIRCLES UNDER EYES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>YELLOW SKIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
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        <drugstartdate>20080804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091123</drugenddate>
        <drugtreatmentduration>476</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>20080221</drugstartdate>
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        <drugenddate>20091123</drugenddate>
        <drugtreatmentduration>641</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137398-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2008US11861</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>250 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137399-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101204</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010TZ52042</companynumb>
    <primarysource>
      <reportercountry>TANZANIA, UNITED REPUBLIC OF</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COARTEM</medicinalproduct>
        <drugauthorizationnumb>022268</drugauthorizationnumb>
        <drugindication>MALARIA</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugindication>MALARIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137400-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
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    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US81904</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
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      <patientweight>68.027</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOBI</medicinalproduct>
        <drugauthorizationnumb>050753</drugauthorizationnumb>
        <drugdosagetext>300 MG, BID</drugdosagetext>
        <drugindication>CYSTIC FIBROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100722</drugstartdate>
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    </patient>
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  <safetyreport>
    <safetyreportid>7137401-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
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    <receiptdateformat>102</receiptdateformat>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010FR18080</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>86</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>HYPERNATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CERTICAN</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>1.5</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEART TRANSPLANT</drugindication>
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        <drugstartdate>20091124</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>20</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEART TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090731</drugstartdate>
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        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
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        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEART TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19871010</drugstartdate>
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  <safetyreport>
    <safetyreportid>7137402-9</safetyreportid>
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    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA72193</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>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100928</drugstartdate>
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  <safetyreport>
    <safetyreportid>7137403-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010DE73679</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientweight>72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA/ZOLEDRONATE T29581+A++OS</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG ONCE YEARLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
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    </patient>
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  <safetyreport>
    <safetyreportid>7137404-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101204</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010TZ52041</companynumb>
    <primarysource>
      <reportercountry>TANZANIA, UNITED REPUBLIC OF</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STILLBIRTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COARTEM</medicinalproduct>
        <drugauthorizationnumb>022268</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALARIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137405-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010MX81736</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>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG/100 ML, ONCE YEARLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137406-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101204</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010TZ52043</companynumb>
    <primarysource>
      <reportercountry>TANZANIA, UNITED REPUBLIC OF</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COARTEM</medicinalproduct>
        <drugauthorizationnumb>022268</drugauthorizationnumb>
        <drugindication>MALARIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137407-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101204</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010TZ52309</companynumb>
    <primarysource>
      <reportercountry>TANZANIA, UNITED REPUBLIC OF</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>PARAPLEGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COARTEM</medicinalproduct>
        <drugauthorizationnumb>022268</drugauthorizationnumb>
        <drugindication>MALARIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137408-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US81614</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>2000 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137409-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR81791</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>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugbatchnumb>UNK.</drugbatchnumb>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5MG/100ML</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALINIA</medicinalproduct>
        <drugdosagetext>6/200MCG ,TWICE DAILY</drugdosagetext>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARADOIS</medicinalproduct>
        <drugdosagetext>100MG, 1 TABLET DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137410-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US77955</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>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugdosagetext>9.5 MG</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100723</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137411-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010IN80731</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>GLIVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137412-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010MX45952</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG PER YEAR</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137413-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US81596</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1750 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SICKLE CELL ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071108</drugenddate>
        <drugtreatmentduration>543</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137414-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GENZYME-THYM-1002132</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100406</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137415-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10110179</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 MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101030</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIL SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137422-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20101108768</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUROTEP MT</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugdosagetext>1.5 PATCHES OF 12.5UG/HR</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137423-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-JNJFOC-20101108696</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugdosagetext>HALF OF 12.5UG/HR PATCH</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137424-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-JNJFOC-20101108691</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</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 DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137425-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20101108762</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUROTEP MT</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugdosagetext>HALF OF 12.5UG/HR PATCH</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137426-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20101200706</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137427-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20101108761</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNDERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUROTEP MT</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUROTEP MT</medicinalproduct>
        <drugdosagetext>HALF OF FENTANYL MATRIX PATCH</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUROTEP MT</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137428-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101108639</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRODUCT ADHESION ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>1004025 P1</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SCIATICA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>1004025 P1</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>INTERVERTEBRAL DISC PROTRUSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137429-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-JNJFOC-20101108330</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137430-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101128</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-JNJFOC-20101108314</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>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137431-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-JNJFOC-20101005509</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOXACIN</medicinalproduct>
        <drugauthorizationnumb>020635</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>POST PROCEDURAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLORIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIATEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLASIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACHIDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEXANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137432-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-PFIZER INC-2010162794</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIC-ISCHAEMIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugauthorizationnumb>050670</drugauthorizationnumb>
        <drugdosagetext>500 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESPIRATORY TRACT INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137433-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090323</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2009-24492</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>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137434-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090401</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2009-24660</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081119</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137435-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2009-24433</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>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091028</drugenddate>
        <drugtreatmentduration>1392</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137436-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090526</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2009-24521</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID OVERLOAD</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090517</drugenddate>
        <drugtreatmentduration>515</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137437-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091020</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2009-27922</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
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    <receivedate>20101206</receivedate>
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    <receiptdate>20091213</receiptdate>
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    <companynumb>US-ACTELION-A-US2009-26585</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
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      <drug>
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        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
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    <receivedate>20101206</receivedate>
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    <receiptdate>20100830</receiptdate>
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      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>FLUID OVERLOAD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>RIGHT VENTRICULAR FAILURE</reactionmeddrapt>
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      <drug>
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        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
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        <drugstartdate>20061208</drugstartdate>
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      <drug>
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        <medicinalproduct>VENTAVIS</medicinalproduct>
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        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080630</drugstartdate>
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      <drug>
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        <medicinalproduct>REVATIO</medicinalproduct>
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      <drug>
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        <medicinalproduct>COUMADIN</medicinalproduct>
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    <transmissiondateformat>102</transmissiondateformat>
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      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
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        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
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        <drugstartdate>20021101</drugstartdate>
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        <drugenddate>20100121</drugenddate>
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    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
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      <reportercountry>GERMANY</reportercountry>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTAVIS</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
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    <safetyreportid>7137457-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
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      <reportercountry>UNITED STATES</reportercountry>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugauthorizationnumb>021290</drugauthorizationnumb>
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        <drugstartdate>20080407</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
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    <safetyreportid>7137458-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
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    <receivedate>20101206</receivedate>
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    <receiptdate>20091021</receiptdate>
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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>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
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        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
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    <safetyreportid>7137459-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <receivedate>20101206</receivedate>
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    <receiptdate>20090529</receiptdate>
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    <companynumb>US-ACTELION-A-US2009-25590</companynumb>
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      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILRINONE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
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    <safetyreportid>7137460-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
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    <receiptdate>20090706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ACTELION-A-US2009-26222</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>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 62.5 MG CD</medicinalproduct>
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        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
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    <safetyreportid>7137461-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
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    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2009-26886</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>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>CARDIAC PACEMAKER INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART VALVE INCOMPETENCE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
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      <drug>
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        <drugstartdateformat>102</drugstartdateformat>
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    <transmissiondateformat>102</transmissiondateformat>
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    <receiptdate>20090908</receiptdate>
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      <reportercountry>UNITED STATES</reportercountry>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
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      <drug>
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        <medicinalproduct>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
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      <drug>
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        <medicinalproduct>REVATIO</medicinalproduct>
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      <reportercountry>UNITED STATES</reportercountry>
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    <receiver></receiver>
    <patient>
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      <reaction>
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    <patient>
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    <receiptdate>20100202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2009-23799</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>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070706</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137500-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090216</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2009-23960</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080715</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137501-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090217</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2009-23977</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>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090206</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137502-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090217</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2009-24040</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>ILOPROST INHALATION SOLUTION 5UG US</medicinalproduct>
        <drugbatchnumb>64280A</drugbatchnumb>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090130</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137503-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090128</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ACTELION-A-US2009-23650</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>BOSENTAN TABLET 62.5 MG CD</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137504-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100426</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2009-24207</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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</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>20080911</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137505-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090312</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2009-24349</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070307</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137506-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2009-23891</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>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137507-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101121</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13092BP</companynumb>
    <primarysource>
      <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>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC 75</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020520</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137508-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010IT74457</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE EROSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK LEFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CENTRAL NERVOUS SYSTEM NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPUTERISED TOMOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOPHTHALMOS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGEAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROENDOCRINE CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SARCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPERINFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR INVASION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>200 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCLERODERMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101012</drugenddate>
        <drugtreatmentduration>140</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugdosagetext>4 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugdosagetext>125 MG X 2, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENAPREN</medicinalproduct>
        <drugdosagetext>5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASEXTEN</medicinalproduct>
        <drugdosagetext>20 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROPRAM</medicinalproduct>
        <drugdosagetext>20 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugdosagetext>10 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORADOL</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>INFUSION AT INCREMENTAL DOSAGES UP TO 90 MG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>4 MG / DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OCTREOTIDE ACETATE</medicinalproduct>
        <drugdosagetext>100 MG X 3/DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLASIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOROLAC TROMETHAMINE</medicinalproduct>
        <drugdosagetext>UNK ENDOVENOUS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXACIN</medicinalproduct>
        <drugdosagetext>500 MG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugdosagetext>3 GY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137509-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15416134</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>87</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugauthorizationnumb>009218</drugauthorizationnumb>
        <drugdosagetext>1DF=11MG ON MON,THU AND SAT AND 10MG ON OTHER DAYS COUMADIN TAKEN FOR 4 TO 5 YRS</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137517-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090804</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2009-26725</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>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
        <drugbatchnumb>82371A</drugbatchnumb>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090710</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137518-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2009-27067</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>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 125 MG US</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090112</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137519-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090915</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2009-27642</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>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
        <drugbatchnumb>82372A</drugbatchnumb>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090907</drugenddate>
        <drugtreatmentduration>63</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137520-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2009-27548</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>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137521-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090618</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2009-25155</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>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090601</drugenddate>
        <drugtreatmentduration>223</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137522-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2009-31931</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137523-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090922</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2009-28124</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 125 MG US</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STARLIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERGOCALCIFEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENSURE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137524-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090506</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2009-27180</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137526-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090811</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2009-26863</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080221</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137527-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090617</receiptdate>
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    <companynumb>US-ACTELION-A-US2009-27981</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137528-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091221</receiptdate>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
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  </safetyreport>
  <safetyreport>
    <safetyreportid>7137529-1</safetyreportid>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090827</receiptdate>
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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>
      <reaction>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
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  <safetyreport>
    <safetyreportid>7137530-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
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  </safetyreport>
  <safetyreport>
    <safetyreportid>7137531-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090313</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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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>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
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        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081209</drugstartdate>
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  <safetyreport>
    <safetyreportid>7137532-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
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    <seriousnessdeath>1</seriousnessdeath>
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    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090219</receiptdate>
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    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081005</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137533-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090224</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2009-24074</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090127</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137534-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2010GB05633</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>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>018927</drugauthorizationnumb>
        <drugdosagetext>5 ML, BID2SDO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137535-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-15293038</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>41</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>IN TOTAL 22 ADMINISTRATION IN 19MAY10(RECENT INF)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>RECENT INF:15APR2010</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>ON DAY 1-15 LAST DOSE:750MG/M2 STOP DATE:25JUN2010 FORM: TAB RECENT INF:26MAY2010</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>ALSO ON 15JUN10 AND 22JUN10</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100608</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137537-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101200625</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137538-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101200022</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 INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugauthorizationnumb>021121</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>NUVIGIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137539-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101200024</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84.37</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRODUCT ADHESION ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>1007262P1</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MANY OTHER UNSPECIFIED MEDICATIONS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137540-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-JNJFOC-20101104836</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>47</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AFFECT LABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROPHYLAXIS OF NAUSEA AND VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVETIRACETAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVETIRACETAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVETIRACETAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>INTERMITTENT</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>L-CARNITINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COENZYME Q10</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIRACETAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137541-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP62291</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>BRAIN STEM HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100912</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137542-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BRISTOL-MYERS SQUIBB COMPANY-15390321</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugauthorizationnumb>009218</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100928</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137544-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BRISTOL-MYERS SQUIBB COMPANY-15398928</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugauthorizationnumb>020357</drugauthorizationnumb>
        <drugdosagetext>1 DF:3 UNITS FORMULATION:1000G</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100922</drugenddate>
        <drugtreatmentduration>628</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MODURETIC 5-50</medicinalproduct>
        <drugdosagetext>1 DF:1 UNIT STRENGTH:5MG AND 50MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100922</drugenddate>
        <drugtreatmentduration>628</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KANRENOL</medicinalproduct>
        <drugdosagetext>1 DF:1 UNIT FORMULATION:100MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100922</drugenddate>
        <drugtreatmentduration>628</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>1 DF:1 UNIT 25MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100922</drugenddate>
        <drugtreatmentduration>628</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENAPREN</medicinalproduct>
        <drugdosagetext>1 DF:1 UNIT 5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100922</drugenddate>
        <drugtreatmentduration>628</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYL SALICYLIC ACID USP BAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUTIROX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRADIF</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRALEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137545-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15417033</companynumb>
    <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 BLADDER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugauthorizationnumb>009218</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137546-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-BRISTOL-MYERS SQUIBB COMPANY-15416225</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>35</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPROTEINAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>NEXT INF ON 25NOV10 STRENGTH:5MG/ML ONGOING</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101014</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>ON DAY 1 OF CYCLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>ON DAY 1-15 TAB</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137547-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ELI_LILLY_AND_COMPANY-GB201011006071</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>INTRACRANIAL PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137548-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-ELI_LILLY_AND_COMPANY-MX201011007112</companynumb>
    <primarysource>
      <reportercountry>MEXICO</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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>30 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137549-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011007094</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>ZYPREXA RELPREVV</medicinalproduct>
        <drugauthorizationnumb>021253</drugauthorizationnumb>
        <drugdosagetext>210 MG, UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100323</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137550-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR201011006482</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>ANGLE CLOSURE GLAUCOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137551-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ELI_LILLY_AND_COMPANY-GB201011005455</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RETINAL ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101005</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137552-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ELI_LILLY_AND_COMPANY-GB201011006469</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>93</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>30 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137553-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011006486</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCHAL RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>1 D/F, UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101115</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137554-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011006492</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>GASTRIC BYPASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGOGASTRIC FUNDOPLASTY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137555-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ELI_LILLY_AND_COMPANY-CA201011006441</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>A761890</drugbatchnumb>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137556-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011006011</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>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugindication>POLYMYALGIA RHEUMATICA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137557-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ELI_LILLY_AND_COMPANY-CA201011006461</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137558-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE201011005891</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100429</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100505</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </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>20100506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100528</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERGENYL</medicinalproduct>
        <drugdosagetext>UNK, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100519</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERGENYL</medicinalproduct>
        <drugdosagetext>1200 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>25 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100427</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>75 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100503</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>15 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100507</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100511</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100527</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>15 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100530</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100603</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugdosagetext>15 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100504</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100516</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugdosagetext>5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100616</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
        <drugdosagetext>4 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100629</drugenddate>
        <drugtreatmentduration>61</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTHIPENDYL</medicinalproduct>
        <drugdosagetext>80 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100527</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137559-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011006515</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>30 MG, 3/D</drugdosagetext>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>15 MG, 2/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>A755195A</drugbatchnumb>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>15 MG, ONE TIME DOSE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugdosagetext>250 MG, 2/D</drugdosagetext>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugdosagetext>1500 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NADOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137560-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-ELI_LILLY_AND_COMPANY-DK201011006788</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRA-UTERINE DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGOHYDRAMNIOS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>POSTPARTUM DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRALEX</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>POSTPARTUM DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137561-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR201011006791</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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>30 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIFLOX</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PYELONEPHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137562-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-SP-2010-06778</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BOVINE TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BLADDER TRANSITIONAL CELL CARCINOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137564-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-SP-2010-03371</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TUBERSOL</medicinalproduct>
        <drugbatchnumb>C2911A</drugbatchnumb>
        <drugadministrationroute>023</drugadministrationroute>
        <drugindication>TUBERCULIN TEST</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090520</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137565-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101200637</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BURSA INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137566-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-SP-2010-03372</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TUBERSOL</medicinalproduct>
        <drugbatchnumb>C2911A</drugbatchnumb>
        <drugadministrationroute>023</drugadministrationroute>
        <drugindication>TUBERCULIN TEST</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091221</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137571-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-SP-2010-03374</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TUBERSOL</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>TUBERCULIN TEST</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070131</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137572-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-50794-10111457</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>132</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA AT REST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARROW HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDAZA</medicinalproduct>
        <drugauthorizationnumb>050794</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101021</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLERIXAFOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101021</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANDROGEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugdosagetext>80/25</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFEPIME</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137573-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-SP-2010-03375</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA FACIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TUBERSOL</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TUBERCULIN TEST</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090529</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137574-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-SP-2010-06066</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TUBERSOL</medicinalproduct>
        <drugbatchnumb>C3506A</drugbatchnumb>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugadministrationroute>023</drugadministrationroute>
        <drugindication>TUBERCULIN TEST</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugdosagetext>2 PUFFS TWICE DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRICANYL</medicinalproduct>
        <drugdosagetext>ONLY BEFORE EXERCISE</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137575-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10112725</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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137588-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2010R1-39922</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugauthorizationnumb>076285</drugauthorizationnumb>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
      </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>DIPYRIDAMOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137589-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2010R1-39347</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugauthorizationnumb>075944</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONGLYZA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100519</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137590-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2010R1-38839</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMPICILLIN SODIUM/SULBACTAM SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>60 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101002</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PETHIDINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEMETIL</medicinalproduct>
        <drugdosagetext>UNK, AS NECESSARY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137591-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-RANBAXY-2010RR-37991</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100616</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100630</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugdosagetext>15 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100705</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugdosagetext>1000 MG, BID</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137592-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RANBAXY-2010US-39742</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>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugauthorizationnumb>076134</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ARTHRITIS ALLERGIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137593-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BAYER-201047388GPV</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENDOMETRIAL CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 A?G (DAILY DOSE), CONT, INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060720</drugstartdate>
        <drugtreatmentduration>1461</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137595-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100818</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201031318NA</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 INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE EXPULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY WITH CONTRACEPTIVE DEVICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 A?G (DAILY DOSE), , INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
        <drugtreatmentduration>1095</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137596-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101200833</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugauthorizationnumb>020281</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137597-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101200646</companynumb>
    <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>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137598-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101200785</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>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO-NOVUM 7/7/7-21</medicinalproduct>
        <drugbatchnumb>9KM702</drugbatchnumb>
        <drugdosagetext>NDC NUMBER- 0062-1781-00</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO-NOVUM 7/7/7-21</medicinalproduct>
        <drugbatchnumb>9KM702</drugbatchnumb>
        <drugauthorizationnumb>018985</drugauthorizationnumb>
        <drugdosagetext>NDC NUMBER- 0062-1781-00</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMIG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137599-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20101105403</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPULSIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERWEIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>021346</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugdosagetext>1 MG AND 2 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COFFEIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137600-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101200708</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>38.56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugauthorizationnumb>020281</drugauthorizationnumb>
        <drugdosagetext>1 DAY AS NEEDED.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAM ER</medicinalproduct>
        <drugauthorizationnumb>020281</drugauthorizationnumb>
        <drugdosagetext>EXTENDED RELEASE.  1 A DAY</drugdosagetext>
        <drugindication>MYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID THERAPY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137601-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101200644</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>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137609-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-15359821</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>12MG FROM 2009-6OCT10, 9MG 7-20OCT10 TD:14DAYS,6MG:21OCT-10NOV TD:21DAYS,3MG 11NOV10-ONGOING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137610-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-15263692</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>
      <patientweight>53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>JAUNDICE CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>RECENT INF-19AUG2010;TOTAL-9 INF;5MG/ML</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100819</drugenddate>
        <drugtreatmentduration>66</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>RECENT INF-19AUG2010</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100819</drugenddate>
        <drugtreatmentduration>66</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>RECENT INF-26AUG2010; ON DAY 1,15</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100614</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137611-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10101955</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AMYLOIDOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137612-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20100708443</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>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137613-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20101201228</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137614-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20101107098</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CYSTITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DISOPYRAMIDE PHOSPHATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLARICID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NATRIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDENALIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC AGENTS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137615-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20100706505</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>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOOSE BODY IN JOINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137616-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-JNJFOC-20101201244</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugauthorizationnumb>021121</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137629-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-MPIJNJ-2010-05961</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021602</drugauthorizationnumb>
        <drugdosagetext>2.2 MG, CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101125</drugenddate>
        <drugtreatmentduration>38</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENDOXAN                            /00021101/</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1260 MG, CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101125</drugenddate>
        <drugtreatmentduration>38</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101125</drugenddate>
        <drugtreatmentduration>38</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137630-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-CELGENEUS-122-21880-10100026</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100927</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100927</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOSAN</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>10-20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137631-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-AMGEN-CANSP2010006724</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VECTIBIX</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137632-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
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    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010007001</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091111</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137633-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-AMGEN-AUSSP2010006696</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>NPLATE</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137634-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN INC.-KDC442645</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIOPULMONARY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANITUMUMAB</medicinalproduct>
        <drugdosagetext>400 MG, Q2WK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100818</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIRUDOID SOFT</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYSER</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALMETA</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RINDERON-V</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137642-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENZYME-FLUD-1000468</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>MALIGNANT MELANOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020038</drugauthorizationnumb>
        <drugdosagetext>25 MG/M2, QDX5</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>METASTATIC MALIGNANT MELANOMA</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>60 MG/KG, QDX2</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>METASTATIC MALIGNANT MELANOMA</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137643-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13091BP</companynumb>
    <primarysource>
      <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>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020850</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137649-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010007285</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHRONIC LYMPHOCYTIC LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100428</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137650-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20101108621</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>PEMPHIGUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugdosagetext>7 INFUSIONS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE AND VITAMIN D</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUINDIONE</medicinalproduct>
        <drugindication>CARDIAC VALVE PROSTHESIS USER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GINKGO BILOBA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137654-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-AVENTIS-2010SA071647</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 FAILURE NEONATAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>016273</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137655-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-TEVA-257847GER</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugauthorizationnumb>075102</drugauthorizationnumb>
        <drugindication>ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137656-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-AVENTIS-2010SA071688</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE MARROW TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>016273</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIURETIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101012</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN AND CLAVULANATE POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101012</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIDIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101004</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UVEDOSE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101018</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101012</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101018</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>7137657-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-TEVA-257960GER</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>075719</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
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    <safetyreportid>7137658-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
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    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-TEVA-256901GER</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NON-HODGKIN'S LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
        <drugauthorizationnumb>075479</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100731</drugenddate>
      </drug>
    </patient>
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    <safetyreportid>7137659-4</safetyreportid>
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    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006983</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>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137660-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7007399</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100816</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE</medicinalproduct>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137661-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-10P-062-0686207-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERGENYL TABLETS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100429</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MANIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100505</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100528</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100503</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100603</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIPERIDEN HYDROCHLORIDE TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100629</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTHIPENDYL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100527</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137666-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-AVENTIS-2010SA073051</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>016273</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137667-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101200330</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRECANCEROUS SKIN LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>0RMA63701</drugbatchnumb>
        <drugdosagetext>INFUSION #10 (DATE OF REPORT)</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>0RMA63701</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDROCAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ CODEINE TAB</medicinalproduct>
        <drugdosagetext>PRN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137676-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10112626</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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137677-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA071514</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>016273</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIAMTERENE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137678-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-MEDIMMUNE-MEDI-0011861</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN AD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERRO-FOLSAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>C VITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101014</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137679-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006883</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugindication>THROMBOCYTOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugindication>EVANS SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137680-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-MEDIMMUNE-MEDI-0011843</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>4.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SENSE OF OPPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101025</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137681-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13225BP</companynumb>
    <primarysource>
      <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>SPIRIVA</medicinalproduct>
        <drugbatchnumb>003817A,0D1002</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137683-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13638BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THROAT CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137684-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101200332</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137685-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101201604</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>ORMKA83002;ORMKA82601</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>ORMKA83002;ORMKA82601</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNSPECIFED MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137686-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101200577</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>10 DOSES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHISTAMINE</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS NOS</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NARCOTIC ANALGESICS, NOS</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137687-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-JNJFOC-20101200364</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>WEEK 0</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>WEEK 0</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACARBOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONTELUKAST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137688-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-JNJFOC-20101200380</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</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>HEPATIC NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COX-1 ANTAGONIST</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137689-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PE-JNJFOC-20101200324</companynumb>
    <primarysource>
      <reportercountry>PERU</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>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUFFOCATION FEELING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>2 VIALS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>5TH TREATMENT DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137690-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20101105014</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>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBCUTANEOUS EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137691-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20101004443</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>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONEAL TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS GASTROINTESTINAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>RECEIVED 1 INFUSION TOTAL</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>RECEIVED 1 INFUSION TOTAL</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>RECEIVED 1 INFUSION TOTAL</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>RECEIVED 1 INFUSION TOTAL</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>RECEIVED 1 INFUSION TOTAL</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>RECEIVED 1 INFUSION TOTAL</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>RECEIVED 1 INFUSION TOTAL</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>RECEIVED 1 INFUSION TOTAL</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>RECEIVED 1 INFUSION TOTAL</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>RECEIVED 1 INFUSION TOTAL</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>RECEIVED 1 INFUSION TOTAL</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>RECEIVED 1 INFUSION TOTAL</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>RECEIVED 1 INFUSION TOTAL</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>RECEIVED 1 INFUSION TOTAL</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>RECEIVED 1 INFUSION TOTAL</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>RECEIVED 1 INFUSION TOTAL</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>RECEIVED 1 INFUSION TOTAL</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>RECEIVED 1 INFUSION TOTAL</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYSLEE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS CITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137692-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20101200381</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>DOSE 2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>DOSE 1</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137702-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GENZYME-CLOF-1001240</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIC SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UROSEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVOLTRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021673</drugauthorizationnumb>
        <drugdosagetext>33 MG, QDX5</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIURETIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100923</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100920</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOMEPROMAZINE</medicinalproduct>
        <drugdosagetext>5.20 MG, QID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIEMETIC SUPPORTIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100908</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOMEPROMAZINE</medicinalproduct>
        <drugdosagetext>5.20 MG, QID</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100908</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SANDO K</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD POTASSIUM DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN K TAB</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COAGULOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101028</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN K TAB</medicinalproduct>
        <drugdosagetext>2 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100908</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SANDO K</medicinalproduct>
        <drugdosagetext>30 UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101028</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE</medicinalproduct>
        <drugdosagetext>16 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIDIARRHOEAL SUPPORTIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100915</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLIZINE</medicinalproduct>
        <drugdosagetext>50 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIEMETIC SUPPORTIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100916</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLIZINE</medicinalproduct>
        <drugdosagetext>50 MG, TID</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100916</drugenddate>
        <drugtreatmentduration>12</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>20100829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100903</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DALTEPARIN SODIUM</medicinalproduct>
        <drugdosagetext>5000 U, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100906</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMILORIDE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIURETIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100907</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMILORIDE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100919</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugdosagetext>10 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALAISE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101026</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>1 G, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugdosagetext>3.75 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100923</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugdosagetext>7.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100930</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAZOCIN</medicinalproduct>
        <drugdosagetext>4.5 G, TID</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANTIBIOTIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100906</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAZOCIN</medicinalproduct>
        <drugdosagetext>4.5 G, TID</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101028</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAZOCIN</medicinalproduct>
        <drugdosagetext>4.5 G, BID</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>750 MG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANTIBIOTIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100921</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
        <drugdosagetext>120 MG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100829</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
        <drugdosagetext>800 MG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANTIBIOTIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100905</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
        <drugdosagetext>390 MG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101026</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
        <drugdosagetext>1 G, TID</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANTIBIOTIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100907</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
        <drugdosagetext>500 MG, QID</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ESCHERICHIA SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100922</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>1 G, TID</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ESCHERICHIA SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100916</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>250 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101105</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FUNGAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100924</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
        <drugdosagetext>10 ML, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100919</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DYSPNOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100923</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugdosagetext>8 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIEMETIC SUPPORTIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100913</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERRIPROX</medicinalproduct>
        <drugdosagetext>1.5 G, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON OVERLOAD</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEFERASIROX</medicinalproduct>
        <drugdosagetext>2 G, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON OVERLOAD</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>50 MCG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugdosagetext>120 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACICLOVIR</medicinalproduct>
        <drugdosagetext>200 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANEXAMIC ACID</medicinalproduct>
        <drugdosagetext>1 G, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PLATELET COUNT DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137704-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAYER-2010-000088</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTOID REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>021085</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTITUSSIVES AND EXPECTORANTS, COMBINATIONS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137705-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BAYER-200934710GPV</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA VAGINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STREPTOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>83482A</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 A?G (DAILY DOSE), CONT, INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090915</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROGRAD</medicinalproduct>
        <drugdosagetext>500 MG (DAILY DOSE), QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090914</drugstartdate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137706-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BAYER-200934710GPV</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOMETRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STREPTOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>83482A</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 A?G (DAILY DOSE), CONT, INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090915</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROGRAD</medicinalproduct>
        <drugdosagetext>500 MG (DAILY DOSE), QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090914</drugstartdate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137707-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101128</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101200004</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.31</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT ADHESION ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>1008025P1</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137708-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101108500</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXIL</medicinalproduct>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugdosagetext>20-35 MG/M2 OVER 1 HOUR ON ON DAY 1, 4 WEEK CYCLES.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTATIC NEOPLASM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>100-125 MG/M2 ON DAY 1 OVER 2 HOURS, 4 WEEK CYCLES</drugdosagetext>
        <drugadministrationroute>013</drugadministrationroute>
        <drugindication>METASTATIC NEOPLASM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugdosagetext>ON DAY 1, OVER 2 HOURS, 4 WEEK CYCLES</drugdosagetext>
        <drugadministrationroute>013</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>ON DAY 1 PRIOR TO CHEMOTHERAPY, 4 WEEK CYCLES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>ON DAYS 1-5 FOLLOWING CHEMOTHERAPY, 4 WEEK CYCLES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137709-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101200676</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.31</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTERED AT INAPPROPRIATE SITE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
        <drugbatchnumb>1000859</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137710-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-JNJFOC-20101108371</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG PRESCRIBING ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugdosagetext>HALF OF 12.5 UG/HR PATCH</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOTILIUM M</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIEMETIC SUPPORTIVE CARE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137717-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010PH79488</companynumb>
    <primarysource>
      <reportercountry>PHILIPPINES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALISKIREN/AMOLODIPINE BESYLATE/HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugdosagetext>75 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>50 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090608</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137718-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR13189</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugdosagetext>4.6 MG, QD</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugdosagetext>9 MG/5CM2 PER DAY</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROLOPA</medicinalproduct>
        <drugdosagetext>1 DF, QID (200/50 MG)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROLOPA</medicinalproduct>
        <drugdosagetext>2 DF, QD (100,25 MG)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDREA</medicinalproduct>
        <drugdosagetext>10 DAYS ON, 14 DAYS OFF</drugdosagetext>
        <drugindication>MYELOPROLIFERATIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLORIC ^FRESENIUS^</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLOW-K</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDROCORTISONE ACETATE</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIFROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137719-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010RO65275</companynumb>
    <primarysource>
      <reportercountry>ROMANIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugindication>METASTASES TO BONE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>2 TB/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAMMA-AMINOBUTYRIC ACID</medicinalproduct>
        <drugdosagetext>3 TB/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137720-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010FR79436</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL VENOUS THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEPONEX</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY</drugdosagetext>
        <drugindication>DISSOCIATIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137721-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010NL79760</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SPINAL ANAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugbatchnumb>S0235</drugbatchnumb>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4MG/5ML PER 21 DAYS</drugdosagetext>
        <drugindication>HYPERCALCAEMIA OF MALIGNANCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugbatchnumb>S0235</drugbatchnumb>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4MG/5ML PER 21 DAYS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugbatchnumb>S0240</drugbatchnumb>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4MG/5ML PER 21 DAYS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101123</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137722-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR80919</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugbatchnumb>UNK.</drugbatchnumb>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>80 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137723-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010FR80432</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREATH ODOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENT DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101021</drugenddate>
        <drugtreatmentduration>204</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPEUTICS,OTHER</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORMONES NOS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137724-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BE80113</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4MG/MONTH</drugdosagetext>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KREDEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERSYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>2 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>1 G, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>D-CURE</medicinalproduct>
        <drugdosagetext>MONTHLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137725-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2008US37132</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugbatchnumb>F0057</drugbatchnumb>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1000 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080903</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137726-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010EG79948</companynumb>
    <primarysource>
      <reportercountry>EGYPT</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>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugdosagetext>4.5MG/24 HOURS</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPOCID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137727-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US80267</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>500 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090918</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137728-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010IT79696</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>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4MG+5ML,  4MG EVERY 28 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137729-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010IT80420</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>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4MG+5ML, 4MG EVERY 28 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137730-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US74932</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 MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CUSHINGOID</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER PALPABLE SUBCOSTAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DESFERAL</medicinalproduct>
        <drugauthorizationnumb>016267</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD TRANSFUSION, AUXILIARY PRODUCTS</medicinalproduct>
        <drugdosagetext>EVERY TWO TO THREE WEEKS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137731-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010GR74124</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>17</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTRANSAMINASAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ICL670A ICL+DISTAB</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>625 MG, (37MG/KG/DAY)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THALASSAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101030</drugenddate>
        <drugtreatmentduration>471</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ICL670A ICL+DISTAB</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugindication>IRON OVERLOAD</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIURENE</medicinalproduct>
        <drugdosagetext>0.5 TSP, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCALCIURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101030</drugenddate>
        <drugtreatmentduration>145</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137732-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR80145</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATHETERISATION CARDIAC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RASILEZ HCT</medicinalproduct>
        <drugbatchnumb>UNK.</drugbatchnumb>
        <drugauthorizationnumb>022107</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RASILEZ HCT</medicinalproduct>
        <drugauthorizationnumb>022107</drugauthorizationnumb>
        <drugdosagetext>300/12.5MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARADOIS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137733-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR80368</companynumb>
    <primarysource>
      <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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL-XR</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020234</drugauthorizationnumb>
        <drugdosagetext>400 MG, TABLET</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137734-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2009US17339</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>ABSCESS ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACETABULUM FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADRENAL ADENOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS CONTACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED SELF-CARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INGROWING NAIL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGAMENT SPRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASTICATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE CALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ONYCHOMYCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PECTUS EXCAVATUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLEEN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugdosagetext>1560 MG, QW2</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORHEXIDINE GLUCONATE</medicinalproduct>
        <drugdosagetext>473 ML, BID</drugdosagetext>
        <drugadministrationroute>004</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HCL</medicinalproduct>
        <drugdosagetext>2 MG, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AROMASIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VISTARIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137735-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010FR17822</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>36.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEILITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE BONE MARROW APLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONATE T29581+SOLINJ+BM</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100311</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VP-16</medicinalproduct>
        <drugdosagetext>98MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugdosagetext>3.9MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIFLOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPHREN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEDIRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137736-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010KR80118</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100317</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137737-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENZYME-CLOF-1001138</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOLAR</medicinalproduct>
        <drugbatchnumb>09-001129; 09-00248, 30-NOV-2010</drugbatchnumb>
        <drugauthorizationnumb>021673</drugauthorizationnumb>
        <drugdosagetext>34 MG, QDX5</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100811</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>170 MG, QDX5</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100810</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MITOXANTRONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>13.6 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100810</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137738-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101021</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA018343</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>82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHANOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137739-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR81095</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</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>DIOVAN AMLO FIX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021990</drugauthorizationnumb>
        <drugdosagetext>500 MG (CORRECT PRESENTATION NOT KNOWN)</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137740-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR75161</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETIT MAL EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN B12 DEFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL-XR</medicinalproduct>
        <drugbatchnumb>Z0213</drugbatchnumb>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>400 MG, UNK</drugdosagetext>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL-XR</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugindication>PETIT MAL EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENDOFOLIN</medicinalproduct>
        <drugdosagetext>5 MG, 1 TABLET A DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137741-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US80749</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUMBAR VERTEBRAL FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIACALCIN</medicinalproduct>
        <drugauthorizationnumb>017808</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIACALCIN</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137752-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US66467</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>43.084</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1000 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060404</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137753-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR79392</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugdosagetext>COATED TABLET (160/12.5 MG)</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AAS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137754-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP09087</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INADEQUATELY CONTROLLED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBELLAR HAEMANGIOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBELLAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALISKIREN/AMOLODIPINE BESYLATE/HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>150 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100127</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPLERENONE</medicinalproduct>
        <drugdosagetext>50 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100126</drugenddate>
        <drugtreatmentduration>159</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDENALIN</medicinalproduct>
        <drugdosagetext>2 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100126</drugenddate>
        <drugtreatmentduration>1244</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100212</drugenddate>
        <drugtreatmentduration>1233</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>2.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONALON</medicinalproduct>
        <drugdosagetext>35 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugdosagetext>600 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugdosagetext>0.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091214</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137755-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US81368</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPHRENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COARTEM</medicinalproduct>
        <drugauthorizationnumb>022268</drugauthorizationnumb>
        <drugdosagetext>120 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MALARONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137757-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2008CA16658</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>200 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080707</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080423</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080505</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugdosagetext>8 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080505</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIPRASIDONE HCL</medicinalproduct>
        <drugdosagetext>80 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080710</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEMADRIN</medicinalproduct>
        <drugdosagetext>7.5 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080902</drugenddate>
        <drugtreatmentduration>121</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUTEIN</medicinalproduct>
        <drugdosagetext>2 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080902</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137758-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010MX81846</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>FORADIL</medicinalproduct>
        <drugauthorizationnumb>020831</drugauthorizationnumb>
        <drugdosagetext>2 INHALATIONS OF 12 MCG  DAILY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137759-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2008AR37244</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050411</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137760-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR81556</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</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137761-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2008AR37247</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>3</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>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19941002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAPAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137762-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010DE54096</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RASILEZ</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>75 MG/DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RASILEZ</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>375 MG/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100812</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RASILEZ</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>75 MG/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100813</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RASILEZ</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>150 MG ONCE DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugdosagetext>75 MG/DAY</drugdosagetext>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137763-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CO81863</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</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>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>80 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137764-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-AVENTIS-2010SA070657</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>DELIRIUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GRAMALIL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYSLEE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERENACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137765-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010FR78044</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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN CARDIAC DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RASILEZ</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>150 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100928</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137766-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2008AR37246</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</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>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970303</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETUMINA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137767-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010MX81698</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugauthorizationnumb>021014</drugauthorizationnumb>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugauthorizationnumb>021014</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137768-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-US-EMD SERONO, INC.-7027117</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101012</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFLUENZA LIKE ILLNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101012</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137769-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR40140</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>1 TABLET (80 MG), DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137770-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010IE66392</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GANGRENE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RASILEZ</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOMIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137771-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-ABBOTT-10P-036-0687579-00</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</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>ANAESTHETIC COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugbatchnumb>89588QA</drugbatchnumb>
        <drugauthorizationnumb>020478</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101122</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137772-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101204</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2009TZ52885</companynumb>
    <primarysource>
      <reportercountry>TANZANIA, UNITED REPUBLIC OF</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAPLEGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COARTEM</medicinalproduct>
        <drugauthorizationnumb>022268</drugauthorizationnumb>
        <drugdosagetext>4 TABLETS BID, 3 DAYS IN A WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137773-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR34591</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>DIOVAN HCT</medicinalproduct>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugdosagetext>160/12.5 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137774-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA80541</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TERMINAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>10 MG EVERY 04 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ACROMEGALY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101028</drugenddate>
        <drugtreatmentduration>3691</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137775-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR81952</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>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugdosagetext>COATED TABLET (160/12.5 MG)</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137776-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US81926</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>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137777-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR81956</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>DIOVAN AMLO FIX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021990</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN TRIPLE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>COATED TABLET (160/12.5/5 MG)</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137778-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101204</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2008TZ03393</companynumb>
    <primarysource>
      <reportercountry>TANZANIA, UNITED REPUBLIC OF</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COARTEM</medicinalproduct>
        <drugauthorizationnumb>022268</drugauthorizationnumb>
        <drugdosagetext>5 SINGLE TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080227</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137779-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101204</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2008TZ06005</companynumb>
    <primarysource>
      <reportercountry>TANZANIA, UNITED REPUBLIC OF</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>16</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COARTEM</medicinalproduct>
        <drugauthorizationnumb>022268</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080406</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137785-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101204</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010TZ18566</companynumb>
    <primarysource>
      <reportercountry>TANZANIA, UNITED REPUBLIC OF</reportercountry>
      <qualification>1</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>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTEPARTUM HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CACHEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STILLBIRTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COARTEM</medicinalproduct>
        <drugauthorizationnumb>022268</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090609</drugenddate>
        <drugtreatmentduration>93</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091021</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137786-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101204</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2009TZ56374</companynumb>
    <primarysource>
      <reportercountry>TANZANIA, UNITED REPUBLIC OF</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>30</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COARTEM</medicinalproduct>
        <drugauthorizationnumb>022268</drugauthorizationnumb>
        <drugdosagetext>2 TABLETS TWICE DAILY FOR 3/7</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANADOL</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137787-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101204</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2009TZ52881</companynumb>
    <primarysource>
      <reportercountry>TANZANIA, UNITED REPUBLIC OF</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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COARTEM</medicinalproduct>
        <drugauthorizationnumb>022268</drugauthorizationnumb>
        <drugdosagetext>4 TABLETS BID, FOR 3 DAYS IN A WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANADOL</medicinalproduct>
        <drugindication>PYREXIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137788-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENZYME-CLOF-1001178</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>51.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBILIRUBINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOLAR</medicinalproduct>
        <drugbatchnumb>10-00423</drugbatchnumb>
        <drugauthorizationnumb>021673</drugauthorizationnumb>
        <drugdosagetext>30 MG, QDX5</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100823</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>150 MG, QDX5</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100822</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MITOXANTRONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>12 MG, QDX3</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100820</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
        <drugdosagetext>1 TAB,  Q4HR PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100819</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE</medicinalproduct>
        <drugdosagetext>2 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100902</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OESOPHAGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100830</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugdosagetext>16 MG, PRN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100824</drugenddate>
        <drugtreatmentduration>7</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>20100819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100825</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFEPIME</medicinalproduct>
        <drugdosagetext>2 G, TID</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FEBRILE NEUTROPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100828</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137790-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-AVENTIS-2010SA072760</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RILUTEK</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020599</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137791-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101103324</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>48.08</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>1000869L</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137803-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA76848</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGRAPHIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALISKIREN ALI+</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>ONE TABLET, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100730</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CHANNEL BLOCKERS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANGIOTENSIN II ANTAGONISTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137804-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010DE30297</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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RASILEZ</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137805-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010RO79309</companynumb>
    <primarysource>
      <reportercountry>ROMANIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXFORGE</medicinalproduct>
        <drugauthorizationnumb>021990</drugauthorizationnumb>
        <drugdosagetext>10/160 MG, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIFLUSAL</medicinalproduct>
        <drugdosagetext>300 MG, DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVACARD</medicinalproduct>
        <drugdosagetext>20 MG, DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEBIVOLOL HCL</medicinalproduct>
        <drugdosagetext>5 MG, DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137806-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011006977</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>COLOUR BLINDNESS ACQUIRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>021368</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137807-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011006514</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>BLINDNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>021368</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137808-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201010004661</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>021368</drugauthorizationnumb>
        <drugdosagetext>20 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137809-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201012000068</companynumb>
    <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>ADCIRCA</medicinalproduct>
        <drugauthorizationnumb>021368</drugauthorizationnumb>
        <drugdosagetext>40 MG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100225</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137810-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ELI_LILLY_AND_COMPANY-CA201010004648</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADCIRCA</medicinalproduct>
        <drugauthorizationnumb>021368</drugauthorizationnumb>
        <drugdosagetext>40 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101022</drugstartdate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADCIRCA</medicinalproduct>
        <drugauthorizationnumb>021368</drugauthorizationnumb>
        <drugdosagetext>5 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
        <drugdosagetext>20 MG, 3/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>50 UG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICRO-K</medicinalproduct>
        <drugdosagetext>16 MEQ, 2/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYUREA</medicinalproduct>
        <drugdosagetext>500 MG, 2/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>40 D/F, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>100 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137811-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ELI_LILLY_AND_COMPANY-CA201011006407</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>021368</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137812-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ELI_LILLY_AND_COMPANY-GB201011006443</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>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugbatchnumb>A776417</drugbatchnumb>
        <drugauthorizationnumb>021368</drugauthorizationnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137813-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201012000170</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>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugindication>PERCUTANEOUS CORONARY INTERVENTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137814-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011006975</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 CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIGHT VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADCIRCA</medicinalproduct>
        <drugauthorizationnumb>021368</drugauthorizationnumb>
        <drugdosagetext>40 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100716</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137815-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US80017</companynumb>
    <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>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100903</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137816-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010RO79630</companynumb>
    <primarysource>
      <reportercountry>ROMANIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXFORGE</medicinalproduct>
        <drugauthorizationnumb>021990</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSPEN</medicinalproduct>
        <drugdosagetext>1000 UI X 4/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75 MG/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137817-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010MX80043</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DIASTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>1 TABLET (160 MG) PER DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>80 MG PER DAY</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>1 TABLET, UNK</drugdosagetext>
        <drugindication>FLUID RETENTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>40 IU, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLEX</medicinalproduct>
        <drugdosagetext>3 TABLETS, DAILY</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137818-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US64660</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEKTURNA</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>150 MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEKTURNA</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>300 MG PER DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137820-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-NOVOPROD-317912</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VICTIM OF CHILD ABUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLIN 70/30</medicinalproduct>
        <drugauthorizationnumb>019991</drugauthorizationnumb>
        <drugindication>OFF LABEL USE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137821-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-NOVOPROD-319109</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>1</drugcharacterization>
        <medicinalproduct>PROTAPHANE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019959</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137822-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-NOVOPROD-317925</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIC COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLIN 70/30</medicinalproduct>
        <drugauthorizationnumb>019991</drugauthorizationnumb>
        <drugindication>OFF LABEL USE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugdosagetext>6 PROBABLY 10, TAB</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19801221</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137823-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NOVOPROD-319111</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugbatchnumb>N/A</drugbatchnumb>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>0.9 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>3 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137824-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-NOVOPROD-319152</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>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTRAPID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>42 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTRAPID</medicinalproduct>
        <drugdosagetext>32 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTAPHANE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019959</drugauthorizationnumb>
        <drugdosagetext>22 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTAPHANE</medicinalproduct>
        <drugauthorizationnumb>019959</drugauthorizationnumb>
        <drugdosagetext>10 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PALLADONE</medicinalproduct>
        <drugdosagetext>1.3 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090112</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOL                          /00661201/</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOCOL</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>12.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIMAGON                         /00108001/</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>18 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIANI</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137825-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-NOVOPROD-317919</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VICTIM OF HOMICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLIN 70/30</medicinalproduct>
        <drugauthorizationnumb>019991</drugauthorizationnumb>
        <drugindication>OFF LABEL USE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137826-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-NOVOPROD-319058</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugbatchnumb>N/A</drugbatchnumb>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137827-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-NOVOPROD-317911</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>10</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIC COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VICTIM OF CHILD ABUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLIN 70/30</medicinalproduct>
        <drugauthorizationnumb>019991</drugauthorizationnumb>
        <drugindication>OFF LABEL USE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137828-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-NOVOPROD-317934</companynumb>
    <primarysource>
      <reportercountry>FINLAND</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>BRAIN INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIC COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VICTIM OF HOMICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULATARD INNOLET</medicinalproduct>
        <drugauthorizationnumb>019959</drugauthorizationnumb>
        <drugindication>OFF LABEL USE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137829-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-313448</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>131.52</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT STORAGE OF DRUG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLIN 70/30</medicinalproduct>
        <drugbatchnumb>YZF0056</drugbatchnumb>
        <drugauthorizationnumb>019991</drugauthorizationnumb>
        <drugdosagetext>60 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLIN 70/30</medicinalproduct>
        <drugbatchnumb>YZF0241</drugbatchnumb>
        <drugauthorizationnumb>019991</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugbatchnumb>XZF0302</drugbatchnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137830-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-NOVOPROD-319117</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</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLIN N</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019959</drugauthorizationnumb>
        <drugdosagetext>40 IU (24 IU IN THE MORNING, 12 IU BEFORE LUNCH AND 4 IU BEFORE GOING SLEEP), QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>AS REQUIRED</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137831-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-NOVOPROD-317943</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VICTIM OF HOMICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIXTARD HUMAN 70/30</medicinalproduct>
        <drugauthorizationnumb>019991</drugauthorizationnumb>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137832-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-NOVOPROD-317921</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>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIC COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VICTIM OF CRIME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLIN 70/30</medicinalproduct>
        <drugauthorizationnumb>019991</drugauthorizationnumb>
        <drugindication>OFF LABEL USE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137833-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-CELGENEUS-028-C5013-10102641</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>SPINAL CORD COMPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugauthorizationnumb>020785</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100920</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100912</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELPHALAN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100912</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100920</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137834-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006366</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHROMOSOME ANALYSIS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNE GLOBULIN NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137835-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MILLENNIUM PHARMACEUTICALS, INC.-2010-04254</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>DEAFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugauthorizationnumb>021602</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELPHALAN HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137845-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ALEXION-A201001305</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIRIS</medicinalproduct>
        <drugdosagetext>600 MG, QWX4</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAROXYSMAL NOCTURNAL HAEMOGLOBINURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIRIS</medicinalproduct>
        <drugdosagetext>900 MG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>150 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>APLASTIC ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugindication>NEUTROPENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT                            /00909301/</medicinalproduct>
        <drugdosagetext>40,000 UNITS, QW</drugdosagetext>
        <drugindication>NEUTROPENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugdosagetext>2 Q4H, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>120 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugdosagetext>125 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON OVERLOAD</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137846-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100920</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NAPPMUNDI-USA-2010-0047160</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INADEQUATE ANALGESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022272</drugauthorizationnumb>
        <drugdosagetext>160 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137847-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA-2010-0055670</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONCUSSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022272</drugauthorizationnumb>
        <drugdosagetext>30 MG, HS</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022272</drugauthorizationnumb>
        <drugindication>BREAKTHROUGH PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG ABUSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137848-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NAPPMUNDI-USA-2010-0054599</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL FAECES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022272</drugauthorizationnumb>
        <drugdosagetext>80 MG, SEE TEXT</drugdosagetext>
        <drugindication>DRUG ABUSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</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>LORAZEPAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137850-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA-2010-0055910</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>DRUG ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEEDLE TRACK MARKS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL CIRCULATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>80 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137851-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA-2010-0055964</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>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137853-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA-2010-0055136</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022272</drugauthorizationnumb>
        <drugdosagetext>240 MG, DAILY</drugdosagetext>
        <drugindication>CANCER PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>BREAKTHROUGH PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMALE HORMONE SHOT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PILL FOR PROSTATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137854-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NAPPMUNDI-USA-2010-0047159</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022272</drugauthorizationnumb>
        <drugdosagetext>160 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>022272</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137855-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-NAPPMUNDI-GBR-2010-0007425</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugauthorizationnumb>074769</drugauthorizationnumb>
        <drugdosagetext>280 MG, UNK</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137856-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-NAPPMUNDI-GBR-2010-0007427</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugdosagetext>140 MG, UNK</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137857-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-NAPPMUNDI-GBR-2010-0007424</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugauthorizationnumb>019516</drugauthorizationnumb>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137858-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA-2010-0056270</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>ELECTROCARDIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021745</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137859-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-GENZYME-CLOF-1001289</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIC COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVOLTRA</medicinalproduct>
        <drugbatchnumb>A453096</drugbatchnumb>
        <drugauthorizationnumb>021673</drugauthorizationnumb>
        <drugdosagetext>26.55 MG, QDX5</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101013</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IDARUBICIN</medicinalproduct>
        <drugdosagetext>21.25 MG, QDX3</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101011</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>354 MG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101015</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101023</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONUM</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101023</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHIN</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101023</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137860-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13044BP</companynumb>
    <primarysource>
      <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 PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTURE WEARER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH LOSS</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>20050212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESCUE INHALER</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137861-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-10P-020-0668057-00</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULIN TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRELONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUTHYROX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137862-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-10P-028-0648436-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.02</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NARCOLEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO POSITIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>80 MG WEEKLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugdosagetext>PATCH</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugindication>GASTRIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIORINAL PLAIN</medicinalproduct>
        <drugdosagetext>1-2 TABLETS</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137871-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-COG342602</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART VALVE STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUSTULAR PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011016</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1021298</drugbatchnumb>
        <drugindication>PUSTULAR PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101124</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137872-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU398992</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BONE MARROW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WALDENSTROM'S MACROGLOBULINAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>12 A?G/KG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081107</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROID NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DANAZOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMINOCAPROIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE EDISYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUETIAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNOGLOBULINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137873-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU431796</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WALKING AID USER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugbatchnumb>018710</drugbatchnumb>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137874-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU397676</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL RESECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090612</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROID NOS</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080619</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137875-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-AMGEN-AUSCT2010003471</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AUTONOMIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CINACALCET HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>021688</drugauthorizationnumb>
        <drugindication>HYPERPARATHYROIDISM SECONDARY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070130</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137876-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU363347</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>15 MG, QWK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137877-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU397832</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>2 A?G/KG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100119</drugenddate>
        <drugtreatmentduration>440</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROID NOS</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugdosagetext>60 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREGABALIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANOLAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCERYL TRINITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA CONCENTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137878-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US59173</companynumb>
    <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>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENTEAL LUBRICATING EYE GEL (NVO)</medicinalproduct>
        <drugbatchnumb>09289</drugbatchnumb>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENTEAL PM LUBRICANT EYE OINTMENT</medicinalproduct>
        <drugbatchnumb>507691</drugbatchnumb>
        <drugdosagetext>3.5 GM, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137879-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010IT74684</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SOPOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>021025</drugauthorizationnumb>
        <drugdosagetext>4.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101024</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DELORAZEPAM</medicinalproduct>
        <drugdosagetext>10 DROPS PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOMOTOR HYPERACTIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101023</drugenddate>
        <drugtreatmentduration>53</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>150 MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101023</drugenddate>
        <drugtreatmentduration>53</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137880-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US66456</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55.329</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTINUCLEAR ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD AGGLUTININS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD TYPE HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCOMPLEMENTAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYSTERECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KYPHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL LAMINECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNDERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1000 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON OVERLOAD</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDODERM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM PLUS D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD TRANSFUSION, AUXILIARY PRODUCTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137881-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA65029</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>30 MG EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>NEUROENDOCRINE CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100805</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPEUTICS NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137882-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2009DE01029</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>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>160 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080229</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>10 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080229</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080229</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugdosagetext>47.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EBRANTIL</medicinalproduct>
        <drugdosagetext>30 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080229</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HCT-GAMMA</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080229</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSUMAN INFUSAT</medicinalproduct>
        <drugdosagetext>4 DF, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19810101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>25 UG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOXONIDINE</medicinalproduct>
        <drugdosagetext>0.2 MG, TID</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137883-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010FR80658</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTAVIA</medicinalproduct>
        <drugdosagetext>1.2 ML (300 MCG)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTAVIA</medicinalproduct>
        <drugdosagetext>0.6 ML, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APROVEL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAHOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARDEGIC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IKOREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANSIPEG</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SECTRAL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137884-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US14750</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTINOMYCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALBUMIN GLOBULIN RATIO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALVEOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CALCIFICATION METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED INTEREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALITIS HERPES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAT NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOLATE DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOBULINS INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKODYSTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPH NODE PALPABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MAXILLOFACIAL OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMOCHROMIC NORMOCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSTRUCTIVE AIRWAYS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIVASCULAR DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SARCOIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN PLAQUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAVELBINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHISTAMINES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOXI</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FASLODEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>50 MG Q PM</drugdosagetext>
        <drugindication>MOOD SWINGS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>75 MG, BID</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugdosagetext>BI-WEEK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETODOLAC</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugdosagetext>1 MG, PRN</drugdosagetext>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORHEXIDINE GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>ONE TABLET AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090225</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORADOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>DYSPNOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>600 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugdosagetext>1 MG, Q12H, PRN</drugdosagetext>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMIG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137885-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2008CA00565</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXPLORATORY OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA REPAIR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL RESECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>20 MG, EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>METASTATIC CARCINOID TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071203</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>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERSYL                                /BEL/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137886-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2009CA25985</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL STONE REMOVAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER EXTREMITY MASS</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</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020103</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137887-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA024513</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>84</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>C267</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE:58 UNIT(S)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>C267</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>HAS INCREASED DOSE PIRO TO AUG-2009 AND LAST MONTH INCREASED FROM 50-53</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>OF003A</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE:55 UNIT(S)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>0F023A</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE:53 UNIT(S)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTICLICK</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugdosagetext>TAKES 3 TWICE DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCARDIA XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugdosagetext>8-12 UNITS BEFORE MEALS</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137888-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20101108482</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>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXIL</medicinalproduct>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER RECURRENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM HYDRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUTROGIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137889-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20100400445</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERPARATHYROIDISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESALAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137893-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2010157580</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugauthorizationnumb>011856</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>2000 MG, 4 BY CYCLES, COURSE 1</drugdosagetext>
        <drugindication>HYPOPHARYNGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>COURSE1, J1, 200 MG BY CYCLES</drugdosagetext>
        <drugindication>HYPOPHARYNGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>COURSE1, J1, 800 MG BY CYCLES</drugdosagetext>
        <drugindication>HYPOPHARYNGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOPHREN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMEND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>POLARAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AERIUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMPERAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CILENGITIDE</medicinalproduct>
        <drugdosagetext>2000 MG ON DAY 1 AND 4; OVER 1 HOUR</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPOPHARYNGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100823</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CILENGITIDE</medicinalproduct>
        <drugdosagetext>2000 MG AT DAY 4, DURING 1 HOUR</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137894-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2010GB05592</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137895-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20101002995</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <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>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137896-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2009CA15583</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEDAL PULSE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL FIELD DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>20 MG, EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>NEUROENDOCRINE TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091019</drugenddate>
        <drugtreatmentduration>788</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>20 MG, EVERY 3 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100602</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SWINE FLU VACCINE, MONOVALENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYPROHEPTADINE HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVO-VENLAFAXINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVO-PANTOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASAPHEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVO-LOPERAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVO-DOCUSATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNATABS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137905-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-ASTRAZENECA-2010SE57142</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALIDOL</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALIDOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPALEPT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEKINET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137906-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ASTRAZENECA-2010SE56622</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARCINOEMBRYONIC ANTIGEN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FASLODEX</medicinalproduct>
        <drugauthorizationnumb>021344</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAMIDRONATE DISODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137907-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-SANOFI-AVENTIS-2010SA070436</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>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION STAPHYLOCOCCAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>021759</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100212</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>021759</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100312</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100312</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100722</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THERAPEUTIC RADIOPHARMACEUTICALS</medicinalproduct>
        <drugdosagetext>1.8 GY IN 23 FRACTIONS (CUMMULATIVE 52.2 GY)</drugdosagetext>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100313</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137908-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRACCO-005615</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOVUE-128</medicinalproduct>
        <drugbatchnumb>AC0P652A</drugbatchnumb>
        <drugauthorizationnumb>018735</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TESTIS CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOVUE-128</medicinalproduct>
        <drugbatchnumb>AC0P652A</drugbatchnumb>
        <drugauthorizationnumb>018735</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOVUE-128</medicinalproduct>
        <drugbatchnumb>AC0P652A</drugbatchnumb>
        <drugauthorizationnumb>018735</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANGIOGRAM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101123</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137909-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA070025</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>93</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIQUID PRODUCT PHYSICAL ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE:25 UNIT(S)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>0F180A</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE:38 UNIT(S)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLOSTAR</medicinalproduct>
        <drugbatchnumb>0F180A</drugbatchnumb>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EYE DROPS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>5MG FOR 2 DAYS THEN 2.5MG FOR NEXT 3 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugdosagetext>WITH MEALS, SLIDING SCALE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D3</medicinalproduct>
        <drugdosagetext>DOSE:1000 UNIT(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAGAN</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPHAGAN</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUSOPT</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAVATAN</medicinalproduct>
        <drugdosagetext>LEFT EYE</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137921-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-GENZYME-CLOF-1001280</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVOLTRA</medicinalproduct>
        <drugauthorizationnumb>021673</drugauthorizationnumb>
        <drugdosagetext>40 MG, QDX5</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101005</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARACYTIN</medicinalproduct>
        <drugdosagetext>2 G, QDX5</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101005</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMACIN</medicinalproduct>
        <drugdosagetext>1 G, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BRONCHOPNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101010</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTAZIDIME</medicinalproduct>
        <drugdosagetext>6 G, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BRONCHOPNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101010</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOXI</medicinalproduct>
        <drugdosagetext>1 U, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101003</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137922-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-JNJFOC-20101200409</companynumb>
    <primarysource>
      <reportercountry>INDIA</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>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA VIRUS TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIC SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BONE SARCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BONE SARCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BONE SARCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BONE SARCOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137935-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PAR PHARMACEUTICAL, INC-2010SCPR002309</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>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANION GAP DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIRUBIN CONJUGATED INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA NITROGEN/CREATININE RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARBON DIOXIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULAR FILTRATION RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPORTAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEGACE ES</medicinalproduct>
        <drugauthorizationnumb>021778</drugauthorizationnumb>
        <drugdosagetext>1 TSP, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DECREASED APPETITE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>160 MG, 1 TAB IN AM AND 2 TAB IN PM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>5/20MG, QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTIN</medicinalproduct>
        <drugdosagetext>10 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>500 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137947-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GENZYME-THYM-1001554</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYOMAVIRUS-ASSOCIATED NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugbatchnumb>C9054NC</drugbatchnumb>
        <drugdosagetext>1.5 MG/KG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>KIDNEY TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100519</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBAMIPIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100527</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SARPOGRELATE HYDROCHLORIDE</medicinalproduct>
        <drugindication>BLOOD DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALGANCICLOVIR HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100612</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAFUTIDINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE SODIUM SUCCINATE</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100519</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137948-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-SANOFI-AVENTIS-2010SA071733</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>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD AMYLASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREAS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APIDRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021629</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUTOPEN 24</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GALVUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137949-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-AVENTIS-2010SA072986</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>
      <patientweight>46</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELPLAT</medicinalproduct>
        <drugauthorizationnumb>021759</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100910</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELPLAT</medicinalproduct>
        <drugauthorizationnumb>021759</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101022</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TS-1</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TS-1</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS CITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPEMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOFERMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOFERMIN R</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101003</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101109</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137950-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SHIRE-SPV1-2010-02090</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTHANUM CARBONATE</medicinalproduct>
        <drugdosagetext>250 UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100709</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137951-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHIRE-SPV1-2008-00912</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDUCT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF INJURIOUS BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</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>20080405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080411</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137953-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SHIRE-SPV1-2010-00405</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTHANUM CARBONATE</medicinalproduct>
        <drugauthorizationnumb>021468</drugauthorizationnumb>
        <drugdosagetext>750 MG, TOTAL DAILY DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101128</drugenddate>
        <drugtreatmentduration>323</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTHANUM CARBONATE</medicinalproduct>
        <drugauthorizationnumb>021468</drugauthorizationnumb>
        <drugdosagetext>1500 MG, TOTAL DAILY DOSE (IMMEDIATELY AFTER MEALS)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091210</drugenddate>
        <drugtreatmentduration>77</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTHANUM CARBONATE</medicinalproduct>
        <drugauthorizationnumb>021468</drugauthorizationnumb>
        <drugdosagetext>750 MG, TOTAL DAILY DOSE (IMMEDIATELY AFTER MEALS)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090925</drugenddate>
        <drugtreatmentduration>78</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugdosagetext>200 MG, TOTAL DAILY DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091216</drugenddate>
        <drugtreatmentduration>349</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTAN</medicinalproduct>
        <drugdosagetext>1500 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090710</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAROL</medicinalproduct>
        <drugdosagetext>2.5 UG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100106</drugenddate>
        <drugtreatmentduration>181</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAROL</medicinalproduct>
        <drugdosagetext>5 UG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINACALCET HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>50 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPARATHYROIDISM SECONDARY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090710</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLORIC                            /00003301/</medicinalproduct>
        <drugdosagetext>100 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLETAL</medicinalproduct>
        <drugdosagetext>200 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOMALLERMIN TR</medicinalproduct>
        <drugdosagetext>1 DF, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>2.5 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGIN</medicinalproduct>
        <drugdosagetext>3000 IU, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENAGEL                            /01459901/</medicinalproduct>
        <drugdosagetext>6000 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137954-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-NOVOPROD-319342</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VICTIM OF HOMICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIXTARD HUMAN 70/30</medicinalproduct>
        <drugauthorizationnumb>019991</drugauthorizationnumb>
        <drugindication>OFF LABEL USE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137955-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-NOVOPROD-319343</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VICTIM OF CRIME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIXTARD HUMAN 70/30</medicinalproduct>
        <drugauthorizationnumb>019991</drugauthorizationnumb>
        <drugindication>OFF LABEL USE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137956-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NOVOPROD-319053</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>42</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIC COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID 30 MIX CHU FLEXPEN</medicinalproduct>
        <drugauthorizationnumb>021172</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID 30 MIX CHU FLEXPEN</medicinalproduct>
        <drugbatchnumb>N/A</drugbatchnumb>
        <drugauthorizationnumb>021172</drugauthorizationnumb>
        <drugdosagetext>18-23 IU QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KINEDAK</medicinalproduct>
        <drugdosagetext>3 TAB, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NU-LOTAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091014</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137957-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-NOVOPROD-319108</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>106</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>0.6 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101012</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>1.2 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101115</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVONORM</medicinalproduct>
        <drugdosagetext>4 MG, QID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASAFLOW</medicinalproduct>
        <drugdosagetext>160 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMCORETIC</medicinalproduct>
        <drugdosagetext>10/25</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPAN</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GALVUS</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101005</drugenddate>
        <drugtreatmentduration>277</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137958-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-NOVOPROD-319340</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VICTIM OF HOMICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIXTARD HUMAN 70/30</medicinalproduct>
        <drugauthorizationnumb>019991</drugauthorizationnumb>
        <drugindication>OFF LABEL USE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137959-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NOVOPROD-319377</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugbatchnumb>NA</drugbatchnumb>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137960-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-315112</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.179</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</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>20100706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100802</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>1.2 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100816</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>1000 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>37.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN                       /00097801/</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137961-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-NOVOPROD-319341</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VICTIM OF HOMICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIXTARD HUMAN 70/30</medicinalproduct>
        <drugauthorizationnumb>019991</drugauthorizationnumb>
        <drugindication>OFF LABEL USE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137962-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-315820</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>123.81</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD AMYLASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRANDIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020741</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugdosagetext>10 UG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRECOSE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970801</drugstartdate>
      </drug>
      <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>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19951101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN                       /00097801/</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>7137963-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-NOVOPROD-316666</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>KYPHOSCOLIOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORDITROPIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019721</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101006</drugenddate>
        <drugtreatmentduration>988</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137964-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EG-SANOFI-AVENTIS-2010SA072087</companynumb>
    <primarysource>
      <reportercountry>EGYPT</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>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100315</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137975-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-CELGENEUS-144-21880-10112727</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>40.406</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101117</drugenddate>
        <drugtreatmentduration>281</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101117</drugenddate>
        <drugtreatmentduration>281</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101117</drugenddate>
        <drugtreatmentduration>281</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM + SULFAMETHOXAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137976-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA072124</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>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>C261</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE:17 UNIT(S)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTICLICK</medicinalproduct>
        <drugbatchnumb>OO75</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137977-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13451BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137978-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13450BP</companynumb>
    <primarysource>
      <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>SPIRIVA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137979-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-CS-01019CS</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>908183</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMETEROL XINAFOATE AND FLUTICASON PROPIONATE POWDER FOR INHALATION</medicinalproduct>
        <drugdosagetext>INHALANT, 50/500 UG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137980-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-06454BP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPIDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>LIPIDS ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>200 MG</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTERVERTEBRAL DISC DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAPAMIL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAPAMIL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA PERIPHERAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCODONE HYDROCHLORIDE</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
        <drugindication>BACK DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>2000 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALISKIREN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICODERM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137982-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-SANOFI-AVENTIS-2010SA072129</companynumb>
    <primarysource>
      <reportercountry>MEXICO</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>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN GLARGINE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137983-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENZYME-FLUD-1000470</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>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT MELANOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NERVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020038</drugauthorizationnumb>
        <drugdosagetext>25 MG/M2, QDX5</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>METASTATIC MALIGNANT MELANOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020038</drugauthorizationnumb>
        <drugdosagetext>25 MG/M2, QDX5</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>60 MG/KG, QDX2</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>METASTATIC MALIGNANT MELANOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>60 MG/KG, QDX2</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLEUKIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>METASTATIC MALIGNANT MELANOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLEUKIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137984-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ASTRAZENECA-2010SE57158</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>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA FACIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMAGNESAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>019810</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137994-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MY-SANOFI-AVENTIS-2010SA066909</companynumb>
    <primarysource>
      <reportercountry>MALAYSIA</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020905</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020905</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODIOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137995-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-SANOFI-AVENTIS-2010SA072134</companynumb>
    <primarysource>
      <reportercountry>MEXICO</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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN GLARGINE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7137996-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101029</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>VE-SANOFI-AVENTIS-2010SA067403</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugauthorizationnumb>020905</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138005-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-314540</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIC COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IDEG FLEXPEN</medicinalproduct>
        <drugdosagetext>11 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100906</drugenddate>
        <drugtreatmentduration>158</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID FLEXPEN</medicinalproduct>
        <drugauthorizationnumb>020986</drugauthorizationnumb>
        <drugdosagetext>APPROX. 15 U, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100906</drugenddate>
        <drugtreatmentduration>158</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>125 UG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100906</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>150 UG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100906</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>137 UG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDOL                              /00002701/</medicinalproduct>
        <drugdosagetext>2 TAB, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSMENORRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100331</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugdosagetext>15 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSMENORRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100330</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugdosagetext>15 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100407</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICONAZOLE NITRATE</medicinalproduct>
        <drugdosagetext>1 SUPP, QD</drugdosagetext>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100331</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOCAIN</medicinalproduct>
        <drugdosagetext>1 INJECTION</drugdosagetext>
        <drugindication>DYSMENORRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100330</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>2000 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSMENORRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100413</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN                           /00413701/</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100527</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugdosagetext>500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100526</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugdosagetext>250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100530</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE COMPOUND                   /00056501/</medicinalproduct>
        <drugdosagetext>12 TSP, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100530</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL ALLERGY SINUS              /00446801/</medicinalproduct>
        <drugdosagetext>2 TAB, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100604</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAYQUIL</medicinalproduct>
        <drugdosagetext>1 DOSE, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100524</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORASEPTIC</medicinalproduct>
        <drugdosagetext>1 PUFF, PRN</drugdosagetext>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100530</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MACROBID</medicinalproduct>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100705</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>5-10 IU, QD (BEDTIME)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138006-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006766</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INCISION SITE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CELL CARCINOMA</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>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138007-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>GR-SANOFI-AVENTIS-2010SA068270</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugauthorizationnumb>020905</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138008-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA072622</companynumb>
    <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 DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE:27 UNIT(S)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTICLICK</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138009-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA072629</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>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE MALFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOULDER ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>0F511A</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>32 UNITS IN THE MORNING, 32 UNITS IN THE EVENING</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLOSTAR</medicinalproduct>
        <drugbatchnumb>0F511A</drugbatchnumb>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138011-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2010159286</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugauthorizationnumb>011856</drugauthorizationnumb>
        <drugdosagetext>0.5 MG/KG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100919</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138012-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007095123</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>VASCULAR PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugauthorizationnumb>050670</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061007</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138013-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-JP-WYE-H17881810</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>57</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ENTEROCOLITIS INFECTIOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION STAPHYLOCOCCAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25MG X2/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091003</drugenddate>
        <drugtreatmentduration>249</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG X2/WEEK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091116</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <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>20081219</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugdosagetext>5 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081219</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138014-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA072663</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 DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE:22 UNIT(S)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APIDRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021629</drugauthorizationnumb>
        <drugdosagetext>7 UNITS IN THE MORNING, 3 UNITS IN THE EVENING</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTICLICK</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021629</drugauthorizationnumb>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138015-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-AVENTIS-2010SA071861</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>ISCHAEMIC STROKE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>021759</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090909</drugenddate>
        <drugtreatmentduration>141</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>021759</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100127</drugenddate>
        <drugtreatmentduration>141</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugauthorizationnumb>020985</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090909</drugenddate>
        <drugtreatmentduration>141</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugauthorizationnumb>020985</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100127</drugenddate>
        <drugtreatmentduration>141</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090909</drugenddate>
        <drugtreatmentduration>127</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100113</drugenddate>
        <drugtreatmentduration>127</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUPANTOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METEOSPASMYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE/SUCCINIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138016-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-US-WYE-H18500510</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugauthorizationnumb>020987</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138017-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-US-WYE-H16993910</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugauthorizationnumb>020987</drugauthorizationnumb>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138018-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2010158221</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>SUFFOCATION FEELING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>50 MG IN THE MORNING AND 75 MG IN THE EVENING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLASTOBAN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>HYPERCALCAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138029-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2010163852</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>EYELID PTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugauthorizationnumb>011459</drugauthorizationnumb>
        <drugdosagetext>0.5 TSP, AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugauthorizationnumb>011459</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100930</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138030-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2009176818</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>MENINGITIS VIRAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugauthorizationnumb>050784</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OROPHARYNGEAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081215</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138031-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033997</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>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100408</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYVASO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138032-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA072721</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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE:15 UNIT(S)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLOSTAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138033-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0687283-00</companynumb>
    <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>ENDOMETRIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYSTERECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPRON DEPOT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020011</drugauthorizationnumb>
        <drugindication>ENDOMETRIOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPRON DEPOT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020011</drugauthorizationnumb>
        <drugindication>ADENOMYOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138034-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0686844-00</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>ABDOMINAL ADHESIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTROINTESTINAL SURGERY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101117</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138035-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GENZYME-RENA-1000908</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSOAS ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021179</drugauthorizationnumb>
        <drugdosagetext>1.5 G, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FULSTAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100426</drugenddate>
      </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>CALTAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138036-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>UA-GENZYME-CAMP-1000499</companynumb>
    <primarysource>
      <reportercountry>UKRAINE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISSEMINATED TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEMTUZUMAB</medicinalproduct>
        <drugbatchnumb>E6636LO03H1</drugbatchnumb>
        <drugdosagetext>12 MG, QDX5</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080727</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEMTUZUMAB</medicinalproduct>
        <drugbatchnumb>09-000385</drugbatchnumb>
        <drugdosagetext>12 MG, QDX3</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090724</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugbatchnumb>P04536</drugbatchnumb>
        <drugdosagetext>1 G, QDX3</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080725</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugbatchnumb>P05363</drugbatchnumb>
        <drugdosagetext>1 G, QDX3</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090724</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090821</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN</medicinalproduct>
        <drugdosagetext>625 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090822</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN</medicinalproduct>
        <drugindication>NASOPHARYNGITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138037-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006801</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100623</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138038-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010007075</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>THROMBOCYTOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>1 A?G/KG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
        <drugindication>THROMBOCYTOPENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138040-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-CEPHALON-2010006250</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>DRUG PRESCRIBING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MODAFINIL</medicinalproduct>
        <drugauthorizationnumb>020717</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NARCOLEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MODAFINIL</medicinalproduct>
        <drugauthorizationnumb>020717</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101202</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138041-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-CELGENEUS-028-21880-10092369</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>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORGANISING PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138048-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100329</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0034015</companynumb>
    <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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100308</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138049-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-SANOFI-AVENTIS-2010SA072850</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIPEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138050-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033949</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>ANEURYSM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100714</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138055-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-DE-WYE-G05337210</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABOUR COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPERATIVE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TREVILOR RETARD</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TREVILOR RETARD</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138057-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-DE-WYE-H18243810</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM DIFFICILE COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIET REFUSAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
        <drugauthorizationnumb>020987</drugauthorizationnumb>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
        <drugdosagetext>500 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST PROCEDURAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100726</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERRO SANOL</medicinalproduct>
        <drugdosagetext>80 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON DEFICIENCY ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100810</drugenddate>
        <drugtreatmentduration>52</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMBOLEX</medicinalproduct>
        <drugdosagetext>3000 IU, 1X/DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100726</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMBUN</medicinalproduct>
        <drugdosagetext>800 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROCEDURAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100810</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugdosagetext>5 G, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100723</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEKOVIT CA</medicinalproduct>
        <drugdosagetext>500 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CALCIUM DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100626</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BERLOSIN</medicinalproduct>
        <drugdosagetext>500 MG, 4X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROCEDURAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100810</drugenddate>
        <drugtreatmentduration>54</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOHEXAL</medicinalproduct>
        <drugdosagetext>25 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100810</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALINOR RETARD</medicinalproduct>
        <drugdosagetext>600 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOKALAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100726</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100810</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XIPAMIDE</medicinalproduct>
        <drugdosagetext>5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100810</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>500 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROCEDURAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100726</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138058-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-HQWYE001224FEB06</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>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTROGEN NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138059-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13530BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</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>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138060-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PH-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-CS-00518CS</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>39.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM BROMIDE</medicinalproduct>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SALMETEROL</medicinalproduct>
        <drugdosagetext>100 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugdosagetext>4 PUF</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100626</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138061-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13640BP</companynumb>
    <primarysource>
      <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>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138062-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-DE-06676PO</companynumb>
    <primarysource>
      <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>PERIPHERAL EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DABIGATRAN</medicinalproduct>
        <drugauthorizationnumb>063267</drugauthorizationnumb>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138063-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>LV-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-AP-00536AP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>97</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugauthorizationnumb>063267</drugauthorizationnumb>
        <drugdosagetext>150 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIP ARTHROPLASTY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100923</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>2X</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENTANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPREX</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISEPTOL</medicinalproduct>
        <drugdosagetext>960 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIFAS</medicinalproduct>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138064-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-ZA-00185ZA</companynumb>
    <primarysource>
      <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>PRADAXA</medicinalproduct>
        <drugauthorizationnumb>063267</drugauthorizationnumb>
        <drugdosagetext>150 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIP ARTHROPLASTY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAREG</medicinalproduct>
        <drugdosagetext>160 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOLOC</medicinalproduct>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138065-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033625</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>CATHETERISATION CARDIAC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090128</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138066-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-SANOFI-AVENTIS-2010SA070281</companynumb>
    <primarysource>
      <reportercountry>GREECE</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>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINORELBINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138067-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-SANOFI-AVENTIS-2010SA072887</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOCORDIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138072-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-SANOFI-AVENTIS-2010SA072924</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>BACK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS SOLOSTAR</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLOSTAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BREVICON 21</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138073-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-ASTRAZENECA-2010SE57212</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>400-800 MG OD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINITRAN</medicinalproduct>
        <drugdosagetext>2+25 MG TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TACHYCARDIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATION FOR MIGRAINE</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138074-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-ASTRAZENECA-2010SE57203</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</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>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugdosagetext>DROSPIRENONE 3 MG, ETHINYL ESTRADIOL 0.03 MG</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138075-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2010SE57213</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>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>021399</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101114</drugenddate>
        <drugtreatmentduration>75</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138076-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2010-42073</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugbatchnumb>EP071P0103</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100813</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138077-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2010-41001</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>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101023</drugenddate>
        <drugtreatmentduration>1138</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138078-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2010-41826</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIOPULMONARY FAILURE</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100820</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138079-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2010-41783</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugbatchnumb>EP071P0103</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
        <drugtreatmentduration>119</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138080-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2010-41582</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>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090311</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CHANNEL BLOCKERS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138081-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2010-41836</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIGHT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELETRI</medicinalproduct>
        <drugbatchnumb>KH012H0101</drugbatchnumb>
        <drugauthorizationnumb>022260</drugauthorizationnumb>
        <drugdosagetext>24 NG/KG, PER MIN</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101112</drugenddate>
        <drugtreatmentduration>72</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101112</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138082-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2010-42197</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELETRI</medicinalproduct>
        <drugbatchnumb>KH010H0101</drugbatchnumb>
        <drugauthorizationnumb>022260</drugauthorizationnumb>
        <drugdosagetext>9 NG/KG, PER MIN</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138083-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2009-31199</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091111</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138084-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ACTELION-A-US2010-41491</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERIAL HYPERTENSION</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101109</drugenddate>
        <drugtreatmentduration>18</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>20091029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101021</drugenddate>
        <drugtreatmentduration>357</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138085-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2010-41730</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIAC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONCOMITANT DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138086-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-10P-167-0685671-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138087-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2010-39723</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugbatchnumb>DP026P0102</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100604</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138088-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2010-41889</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 62.5 MG US</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIXED CONNECTIVE TISSUE DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101020</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138089-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-ABBOTT-10P-151-0620558-00</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLACID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>HIGH DOSE</drugdosagetext>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>LONG TERM</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138090-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2010-41066</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138091-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-10P-062-0679472-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNE SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARCUMAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138092-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-TEVA-252524ISR</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>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZILECT</medicinalproduct>
        <drugauthorizationnumb>021641</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100817</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>STALEVO 100</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>STALEVO 100</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
        <drugindication>BURNING MOUTH SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138093-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-TEVA-183728ISR</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugauthorizationnumb>065154</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080806</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080806</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASCITES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080829</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD URIC ACID INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080829</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080829</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080829</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORASEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASCITES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080829</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138094-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-257864USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugindication>MENOPAUSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138095-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-258005USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugindication>INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBETASOL</medicinalproduct>
        <drugindication>DERMATITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBETASOL</medicinalproduct>
        <drugindication>PRURITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOCARBAMOL</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>DERMATITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugindication>INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138096-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-257528USA</companynumb>
    <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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMEDIATE POST-INJECTION REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugauthorizationnumb>020622</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138097-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-257551USA</companynumb>
    <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>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugauthorizationnumb>020622</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138098-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-257554USA</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>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugauthorizationnumb>020622</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138099-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-257586USA</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugauthorizationnumb>020622</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138100-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-257423USA</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugauthorizationnumb>020622</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101028</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138101-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20101108858</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BASOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHLORAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPROTEINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUSTATIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>HAIRY CELL LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUSTATIN</medicinalproduct>
        <drugauthorizationnumb>020229</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRAN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URINORM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLORIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAKTAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138104-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101200669</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52.62</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXPIRED DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
        <drugbatchnumb>0828238</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI-HYPERTENSION MEDICATION, NOS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIAC MEDICATIONS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER MEDICATIONS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138105-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA073028</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>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE:60 UNIT(S)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTICLICK</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138106-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-SANOFI-AVENTIS-2010SA071813</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>CHOLANGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>021759</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUROTRAT FORTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138107-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010007154</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANISOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET MORPHOLOGY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POIKILOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101117</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138110-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2010-42007</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>TRANSFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
        <drugbatchnumb>01510H</drugbatchnumb>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100304</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138111-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2010-41986</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugbatchnumb>EP073P0103</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
        <drugtreatmentduration>260</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTAVIS</medicinalproduct>
        <drugbatchnumb>01510H</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CHANNEL BLOCKERS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138112-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033715</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101106</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138116-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100901</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA045583</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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTAQ</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022425</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138117-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-JNJFOC-20091206591</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</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>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugdosagetext>ALSO 0.5 MG WAS PRESCRIBED AS ADD ON AS NECESSARY (PRN)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLECALCIFEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138120-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033956</companynumb>
    <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</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100726</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138121-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-CELGENEUS-056-C5013-10112898</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>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CC-5013\PLACEBO</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101125</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101125</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101125</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101125</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYNORM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BONE PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101125</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INIPOMP</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PEPTIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101125</drugenddate>
        <drugtreatmentduration>38</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101125</drugenddate>
        <drugtreatmentduration>38</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENANTONE LP</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101125</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138122-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10112762</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>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101022</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138124-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>A8022/01-A</drugbatchnumb>
        <drugdosagetext>REVLIMID DAILY ORALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELOFIBROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MTP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138125-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-CELGENEUS-013-21880-10112787</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYSIPELAS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEXANE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138126-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-SANOFI-AVENTIS-2010SA069629</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</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>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTAQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>022425</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138127-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10120055</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</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>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091110</drugenddate>
        <drugtreatmentduration>236</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090401</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138128-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-20785-10110687</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 OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>020785</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138129-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-JNJFOC-20101106990</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GOLIMUMAB</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GOLIMUMAB</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GOLIMUMAB</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugindication>LATENT TUBERCULOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138130-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-JNJFOC-20101108865</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>5 INFUSIONS TOTAL</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138131-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101200480</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>110</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDICECTOMY</reactionmeddrapt>
      </reaction>
      <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>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138132-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101200344</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>0RMA64303</drugbatchnumb>
        <drugdosagetext>5MG/KG, INFUSION #3</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>0RMA64303</drugbatchnumb>
        <drugdosagetext>5MG/KG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138133-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10113191</companynumb>
    <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>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <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>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138134-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033974</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100422</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138136-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>30 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100616</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138138-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>114</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>5 MG EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100904</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138141-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10113075</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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100528</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138142-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10113181</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>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138143-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-SANOFI-AVENTIS-2010SA071673</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DRONEDARONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022425</drugauthorizationnumb>
        <drugdosagetext>DOSE:1 UNIT(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINTROM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138144-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10113200</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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138145-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAXTER-2010BH029224</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138146-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-JNJFOC-20101108925</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <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>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138147-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101108958</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>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138148-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USANI2010003697</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>
      <reaction>
        <reactionmeddrapt>FEMORAL ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELATONIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B                          /00056102/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMCINOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBETASOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138149-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-AVENTIS-2010SA071951</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTAQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>022425</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138150-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC.-2010-RO-01543RO</companynumb>
    <primarysource>
      <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>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugbatchnumb>NR</drugbatchnumb>
        <drugauthorizationnumb>077262</drugauthorizationnumb>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOVASCULAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101105</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138151-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC.-2010-RO-01524RO</companynumb>
    <primarysource>
      <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>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACARBOSE</medicinalproduct>
        <drugbatchnumb>NR</drugbatchnumb>
        <drugauthorizationnumb>078470</drugauthorizationnumb>
        <drugdosagetext>75 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOGLYCAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
        <drugdosagetext>3 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
        <drugdosagetext>50 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXALT</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138152-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC.-2010-RO-01523RO</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>084610</drugauthorizationnumb>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOTUZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LENALIDOMIDE</medicinalproduct>
        <drugdosagetext>25 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM PLUS VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138153-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-257224USA</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 CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugauthorizationnumb>020622</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138154-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BAXTER-2010BH027528</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD LIQUID</medicinalproduct>
        <drugbatchnumb>LE12K173AE</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PLASMAPHERESIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugtreatmentduration>71</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ILOMEDIN</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIQUEMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DISALUNIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECORTIN-H</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BOSENTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTOXIFYLLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIOPAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLCYSTEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALINOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLECALCIFEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138155-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>A09A24/22-A</drugbatchnumb>
        <drugdosagetext>25MG DAILY 21D/28D ORALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PGE-1/PAPAVERINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138157-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>A10A22/04-A</drugbatchnumb>
        <drugdosagetext>10MG CELGENE DAILY 21D/28D ORALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138159-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>A08021/06-B</drugbatchnumb>
        <drugdosagetext>5MG DAILY ORALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLOPRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOLAZONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN 70/30</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPECIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NTG SL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138160-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-AVENTIS-2010SA063716</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>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYMYOSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELPLAT</medicinalproduct>
        <drugauthorizationnumb>021759</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>LARGE INTESTINE CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080718</drugenddate>
        <drugtreatmentduration>295</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELPLAT</medicinalproduct>
        <drugauthorizationnumb>021759</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090508</drugenddate>
        <drugtreatmentduration>295</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>LARGE INTESTINE CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080718</drugenddate>
        <drugtreatmentduration>295</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090508</drugenddate>
        <drugtreatmentduration>295</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM LEVOFOLINATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LARGE INTESTINE CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080718</drugenddate>
        <drugtreatmentduration>474</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM LEVOFOLINATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091103</drugenddate>
        <drugtreatmentduration>474</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>5-FU</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LARGE INTESTINE CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080718</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>5-FU</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091113</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138161-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2010SE56347</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugauthorizationnumb>018240</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIATUS HERNIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLECAINIDE ACETATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXOMIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXOMIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138162-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2010SE57328</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>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>160 MCG TWO TIMES A DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101126</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138163-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2010SE56630</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>15.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugauthorizationnumb>018240</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLYCOGEN STORAGE DISEASE TYPE II</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYOZYME</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLYCOGEN STORAGE DISEASE TYPE II</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138164-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-707516</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>158.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100519</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100519</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>DOSE: 6 AUC.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100519</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>SEASONAL ALLERGY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARINOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100409</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100519</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100519</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100519</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOXI</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100519</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138166-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0660589-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFDINIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050739</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138167-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0617737-00</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>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNICEF</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050739</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138168-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0622645-00</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNICEF</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050739</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POSTOPERATIVE WOUND INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100120</drugstartdate>
      </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>DOXAZOSIN</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>OMEPRAZOLE</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>7138171-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB 1134MG</medicinalproduct>
        <drugdosagetext>15MG/KG Q 21 DAYS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101117</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138175-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>A09021/01-A</drugbatchnumb>
        <drugdosagetext>5MG DAILY ORALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOXIDIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLENDIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVELAMER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138177-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-09P-163-0595591-00</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>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNICEF</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050739</drugauthorizationnumb>
        <drugindication>VIRAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090820</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNICEF</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050739</drugauthorizationnumb>
        <drugindication>PHARYNGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138178-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0654278-00</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>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNICEF</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050739</drugauthorizationnumb>
        <drugindication>INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138179-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-09P-163-0601476-00</companynumb>
    <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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY THROAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERUCTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT TASTE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNICEF</medicinalproduct>
        <drugbatchnumb>700016RA</drugbatchnumb>
        <drugauthorizationnumb>050739</drugauthorizationnumb>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNICEF</medicinalproduct>
        <drugbatchnumb>700016RA</drugbatchnumb>
        <drugauthorizationnumb>050739</drugauthorizationnumb>
        <drugindication>EAR INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugindication>BLOOD POTASSIUM DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138180-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033976</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>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101013</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138181-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0686016-00</companynumb>
    <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 HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNICEF</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050739</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMPICILLIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENICILLIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138182-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-432382</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>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010126</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138183-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0683158-00</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFDINIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050739</drugauthorizationnumb>
        <drugindication>PHARYNGITIS STREPTOCOCCAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugindication>SEASONAL ALLERGY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138185-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0688377-00</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNICEF</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050739</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138186-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100505</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0643222-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNICEF</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050739</drugauthorizationnumb>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138187-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100224</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-09P-163-0615620-00</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNICEF</medicinalproduct>
        <drugbatchnumb>650066RA</drugbatchnumb>
        <drugauthorizationnumb>050739</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138188-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100630</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0654585-00</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFDINIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050739</drugauthorizationnumb>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100407</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PAIN IN EXTREMITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REPRAXAIN(HYDROCODONE + IBUPROFEN)</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>10/200MG</drugdosagetext>
        <drugindication>PAIN IN EXTREMITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138189-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0622268-00</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>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNICEF</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050739</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138190-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100618</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0622119-00</companynumb>
    <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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNICEF</medicinalproduct>
        <drugbatchnumb>660016RA</drugbatchnumb>
        <drugauthorizationnumb>050739</drugauthorizationnumb>
        <drugindication>PHARYNGITIS STREPTOCOCCAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100119</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138191-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100309</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-09P-163-0612864-00</companynumb>
    <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>OMNICEF</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050739</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138192-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100722</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0659654-00</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>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNICEF</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050739</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETODOLAC</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYDONE</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138193-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100809</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0663139-00</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>CEFDINIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050739</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138194-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0673215-00</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TOOTH DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFDINIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050739</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138195-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-663161</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>BLADDER ADENOCARCINOMA STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO PERITONEUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091126</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANDROTARDYL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060913</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138197-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-09P-163-0613800-00</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>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNICEF</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050739</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138198-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100309</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-09P-163-0609302-00</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>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNICEF</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050739</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138199-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-706642</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL DRYNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY HESITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>B60009, B60039</drugbatchnumb>
        <drugdosagetext>FORM: INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRALEX</medicinalproduct>
        <drugdosagetext>DRUG REPORTED AS CIPROLEX</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138200-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-713587</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>LAST DOSE PRIOR TO SAE: 25 JUNE 2010</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>LAST DOSE PRIOR TO SAE: 25 JUNE 2010</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100625</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugdosagetext>LAST DOSE PRIOR TO SAE: 04 JUNE 2010</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>LAST DOSE PRIOR TO SAE: 04 JUNE 2010</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138201-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ALLERGAN-1014684US</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH BREATHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUMIGAN</medicinalproduct>
        <drugauthorizationnumb>021275</drugauthorizationnumb>
        <drugdosagetext>1 GTT, QD</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100725</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BROMFENAC SODIUM</medicinalproduct>
        <drugdosagetext>1 GTT, BID</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>CATARACT OPERATION COMPLICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100725</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOXIFLOXACIN HCL</medicinalproduct>
        <drugdosagetext>1 GTT, QID</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>CATARACT OPERATION COMPLICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100725</drugenddate>
        <drugtreatmentduration>45</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RINDERON                           /00008501/</medicinalproduct>
        <drugdosagetext>1 GTT, QID</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>CATARACT OPERATION COMPLICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100725</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMOX</medicinalproduct>
        <drugdosagetext>1 DF, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CATARACT OPERATION COMPLICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100615</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMOX</medicinalproduct>
        <drugdosagetext>1 DF, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100621</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROMIA                           /00023516/</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138202-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-715637</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>ANAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CALCULUS URINARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL AMYLOIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL EROSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GROIN PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR SPINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG ADENOCARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LYMPH NODES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-SMALL CELL LUNG CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINE ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100721</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080807</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080904</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081126</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081224</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090218</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090319</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090415</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090513</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090708</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090805</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>PREDOHAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>FORM:SUPPOSITORY RECTALE</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORCAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080810</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METALCAPTASE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISCOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYDOXAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100730</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLETAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONALON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLURBIPROFEN</medicinalproduct>
        <drugdosagetext>FORM: TAPE, DOSAGE UNCERTAIN, DRUG:ADOFEED</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100721</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100721</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS CITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLARICID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
        <drugdosagetext>FORM: PREORAL AGENT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100806</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138203-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>ALPHA GLOBULIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPID METABOLISM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>A09022/06-A</drugbatchnumb>
        <drugdosagetext>10 MG DAILY ORALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100514</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SOLUTION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXEMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSROBIDE MONONITRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138205-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-719663</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL CORD COMPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAZOPANIB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOMIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERCIAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOPHIDONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138206-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-719932</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>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>FREQUENCY:DAY 1 AND 15 OF 3 WEEK CYCLE. ACTUAL DOSE GIVEN:1500MG. LAST DOSE PRIOR TO SAE: 6 AUG 2010</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>FREQUENCY: DAY 1 OF 3 WEEKS CYCLE. ACTUAL DOSE RECEIVED:211MG. LAST DOSE PRIOR TO SAE: 26 JUL 2010</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugdosagetext>SCHEDULE REPORTED AS 20G- 0 -20G</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UNEVALUABLE EVENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100806</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERGENTAN</medicinalproduct>
        <drugdosagetext>SCHEDULE REPORTED AS 2X1</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100806</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100803</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MCP</medicinalproduct>
        <drugdosagetext>DOSE REPORTED AS 3X5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100728</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
        <drugdosagetext>ONCE  A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100806</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138207-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-ROCHE-723281</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYP COLORECTAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>LAST DOSE PRIOR TO SAE: 08 JUN 2010.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138208-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-727852</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOBILIARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIGHT VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TORSADE DE POINTES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>B6004</drugbatchnumb>
        <drugdosagetext>DOSE LEVEL:15 MG/KG. DATE OF LAST DOSE PRIOR TO SAE:10 SEPTEMBER 2010. DOSE FORM:VIALS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASTUZUMAB</medicinalproduct>
        <drugbatchnumb>B1559</drugbatchnumb>
        <drugdosagetext>DOSE LEVEL:6 MG/KG. DATE OF LAST DOSE PRIOR TO SAE:10 SEPTEMBER 2010. DOSE FORM:VIALS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugbatchnumb>D0A152</drugbatchnumb>
        <drugdosagetext>DOSE LEVEL:75 MG/M2.DATE OF LAST DOSE PRIOR TO SAE:10 SEPTEMBER 2010.DOSE FORM:VIALS.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugbatchnumb>D0A152</drugbatchnumb>
        <drugdosagetext>DOSE REDUCED BY ONE DOSE LEVEL. DOSE LEVEL:60 MG/M2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>DOSE LEVEL:6 AUC. DATE OF LAST DOSE PRIOR TO SAE:10 SEPTEMBER 2010. DOSE FORM:VIALS.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>DOSE REDUCED BY ONE DOSE LEVEL. DOSE LEVEL:5 AUC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138209-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-728042</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>FOCAL SEGMENTAL GLOMERULOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>DOSAGE IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugdosagetext>DOSAGE IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138212-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANCER PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-HODGKIN'S LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLASMACYTOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RAYNAUD'S PHENOMENON</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>A08024/14-A</drugbatchnumb>
        <drugdosagetext>25MG DAILY ORALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100410</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAMELOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138214-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>A09022/06-A</drugbatchnumb>
        <drugdosagetext>10MG DAILY ORALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100430</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D (ORAL SUPPLEMENT)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138216-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-734168</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>LAST DOSE BEFORE SAE 3 NOV 2010,CUMULATIVE DOSE : 650 MG,CYCLE 1,THERAPY CYCLE POSTPONED FOR 1 WEEK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugdosagetext>LAST DOSE PRIOR TO SAE: 30 SEP 2010, CUMULATIVE DOSE: 220 MG, CYCLE 1</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100930</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138217-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-739925</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>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASTUZUMAB</medicinalproduct>
        <drugdosagetext>FORM: INFUSION, LAST DOSE PRIOR TO SAE: 07 OCTOBER 2010, TEMPORARILY INTERRUPTED</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERTUZUMAB</medicinalproduct>
        <drugdosagetext>LAST DOSE PRIOR TO SAE: 07 OCTOBER 2010, TEMPORARILY INTERRUPTED</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>INFUSION, LAST DOSE PRIOR TO SAE: 07 OCTOBER 2010, TEMPORARILY INTERRUPTED</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>INFUSION, LAST DOSE PRIOR TO SAE: 07 OCTOBER 2010 , TEMPORARILY INTERRUPTED</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101108</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138218-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHIRE-SPV1-2010-02091</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>INTENTIONAL SELF-INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTUNIV</medicinalproduct>
        <drugauthorizationnumb>022037</drugauthorizationnumb>
        <drugdosagetext>2 MG, 1X/DAY:QD</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTUNIV</medicinalproduct>
        <drugauthorizationnumb>022037</drugauthorizationnumb>
        <drugdosagetext>1 MG, 1X/DAY:QD</drugdosagetext>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138219-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ROCHE-740221</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>TEMPORARILY INTERRUPTED, FREQUENCY: 12 HR X 14 DAYS, DATE OF LAST DOSE PRIOR TO SAE: 28 OCT 2010</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>DOSAGE FORM: VIAL. TEMPORARILY INTERRUPTED, DATE OF LAST DOSE PRIOR TO SAE: 14 OCT 2010</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugdosagetext>DOSAGE NOT REPORTED</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugdosagetext>TEMPORARILY INTERRUPTED, DATE OF LAST DOSE PRIOR TO SAE: 14 OCT 2010</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101106</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138220-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010007067</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</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>
        <drugindication>HYPERPARATHYROIDISM SECONDARY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138221-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>A08021/06-B</drugbatchnumb>
        <drugdosagetext>5MG DAILY ORALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELOPROLIFERATIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138222-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-740400</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WOUND COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION STAPHYLOCOCCAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>1000 MG/M2, BID, D1-D15 OF 3 WEEK CYCLE, LAST DOSE PRIOR TO SAE ON 12 MAR 2010.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100312</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100722</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>50 MG/M2 ON D1, 8, 15, 22 AND 29</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100312</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138223-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-741630</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugbatchnumb>B0004, B0013</drugbatchnumb>
        <drugdosagetext>FORM: INFUSION; 8 MG/KG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>FREQUENCY NOT LEGIBLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090130</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138224-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-SANOFI-AVENTIS-2010SA051785</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>021759</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100805</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100805</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100805</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100805</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PALONOSETRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETANOID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPAMON ^INTRAMED^</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLIZINE HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138225-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-015981-10</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>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DELSYM</medicinalproduct>
        <drugdosagetext>PATIENT DRANK 3-4 OZ</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138226-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010000528</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100413</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138231-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>
      <patientweight>131</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUCCINYLCHOLINE CHLORIDE</medicinalproduct>
        <drugdosagetext>230 MG ONCE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SURGERY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138236-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugdosagetext>800 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101115</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138239-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KW-TEVA-257698ISR</companynumb>
    <primarysource>
      <reportercountry>KUWAIT</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>089158</drugauthorizationnumb>
        <drugdosagetext>144 G/M2</drugdosagetext>
        <drugindication>BONE SARCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugindication>BONE SARCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugindication>BONE SARCOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138240-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-TEVA-257730ISR</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE RUPTURE OF MEMBRANES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugauthorizationnumb>076618</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugauthorizationnumb>076618</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138241-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033906</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 FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138242-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-667353</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACUTAN</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138243-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-729348</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PERNICIOUS ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugdosagetext>OTHER INDICATION: ANTI PHOSPHOLIPID SYNDROME</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugdosagetext>OTHER INDICATION: ANTI PHOSPHOLIPID SYNDROME, FORM: INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138244-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-730428</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>DYSPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APRANAX</medicinalproduct>
        <drugauthorizationnumb>018164</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IXPRIM</medicinalproduct>
        <drugdosagetext>IF REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPECIAFOLDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138245-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-730574</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>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138246-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>
      <patientweight>127</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF-MEDICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>N/A</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>N/A</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101106</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138248-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006869</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SENSIPAR</medicinalproduct>
        <drugauthorizationnumb>021688</drugauthorizationnumb>
        <drugindication>HYPERPARATHYROIDISM SECONDARY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138252-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>128</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>15 MG ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugdosagetext>200 MG ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101027</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138257-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>119</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugdosagetext>1 TAB BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101008</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138260-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-735147</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>DRUG: MYLAN OMEPRAZOLE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBAZAM</medicinalproduct>
        <drugdosagetext>DRUG: TEVA CLOBAZAM</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REACTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138261-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-739666</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL HERNIA OBSTRUCTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138262-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-740251</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>BILE DUCT STONE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138263-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-ROCHE-742456</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEMYELINATING POLYNEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACTEMRA</medicinalproduct>
        <drugdosagetext>FORM: INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100422</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACTEMRA</medicinalproduct>
        <drugdosagetext>480 MG:TOTAL MONTHLY DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACTEMRA</medicinalproduct>
        <drugdosagetext>480 MG:TOTAL MONTHLY DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100728</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACTEMRA</medicinalproduct>
        <drugdosagetext>480 MG:TOTAL MONTHLY DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACTEMRA</medicinalproduct>
        <drugdosagetext>480 MG:TOTAL MONTHLY DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACTEMRA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138264-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ROCHE-742982</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</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>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>DOSE, FORM, FREQUENCY, ROUTE: NOT REPORTED.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>5-FU</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138265-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101021</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201022829BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.636</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugbatchnumb>206230C</drugbatchnumb>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNCODEABLE ^UNCLASSIFIABLE^</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138266-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100922</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201021669BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55.455</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugbatchnumb>213410M</drugbatchnumb>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONE A DAY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE 81 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugindication>MENOPAUSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138267-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EE-ROCHE-743211</companynumb>
    <primarysource>
      <reportercountry>ESTONIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDROTHORAX</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>FREQUENCY: 3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100916</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138268-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-MPIJNJ-2010-05976</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <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>20090526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091112</drugenddate>
        <drugtreatmentduration>171</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091112</drugenddate>
        <drugtreatmentduration>171</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRINE BAYER</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>20 UNK, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DISTRANEURIN                       /00027501/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STILNOX                            /00914901/</medicinalproduct>
        <drugdosagetext>12.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAFALGAN                           /00020001/</medicinalproduct>
        <drugdosagetext>1 G, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYNORM</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMPORTAL</medicinalproduct>
        <drugdosagetext>20 ML, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DERMOVATE</medicinalproduct>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138269-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>
      <patientweight>114</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>1680 MG ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100813</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>7 TAB ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100813</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138271-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-743420</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>FORM: INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138272-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-ROCHE-743518</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>3</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>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugdosagetext>FREQUENCY REPORTED AS QD.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101009</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138274-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-744580</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACUTAN</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138276-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>
      <patientweight>144</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANTIPSYCHOTIC DRUG LEVEL ABOVE THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG CLEARANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugdosagetext>900 MG EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MANIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090603</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>25 MG EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090603</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138278-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugdosagetext>150 MG EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMILORIDE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>5 MG EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100926</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138282-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DALTEPARIN SODIUM</medicinalproduct>
        <drugdosagetext>12500 UNITS EVERY DAY SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100707</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>7.5 MG EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100708</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138284-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-744876</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>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>781040</drugbatchnumb>
        <drugdosagetext>FREQUENCY 1,8,15</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IXABEPILONE</medicinalproduct>
        <drugbatchnumb>0D027</drugbatchnumb>
        <drugdosagetext>FREQUENCY 1,15</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE MALEATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138285-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-ROCHE-743555</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>3</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>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugdosagetext>FREQUENCY REPORTED AS QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100410</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138286-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ROCHE-743677</companynumb>
    <primarysource>
      <reportercountry>CHINA</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>HEPATITIS FULMINANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN URINE PRESENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>5-FU</medicinalproduct>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM FOLINATE</medicinalproduct>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101028</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138287-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-ROCHE-744817</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138288-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-ROCHE-745360</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138289-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-742490</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOTRETINOIN</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACNE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138290-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-743483</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138291-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-743737</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>LAST DOSE PRIOR TO SAE: 19 NOV 2010</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>FROM D1, 8,15.22 AND 29., DATE OF LAST DOSE PRIOR TO SAE: 17 NOV 2010</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101020</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138292-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC.-2010-RO-01550RO</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRODUCT TASTE ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugbatchnumb>957693A</drugbatchnumb>
        <drugauthorizationnumb>070434</drugauthorizationnumb>
        <drugdosagetext>1.5 ML</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138293-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0688801-00</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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101130</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138294-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090819</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-743892</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138297-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</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>BLINDNESS CORTICAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPERFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>22.5 MG QWEEK PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100702</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138302-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>76.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMOZOLOMIDE</medicinalproduct>
        <drugdosagetext>150MG/M2 PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100306</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZACTIMA (ZD6474)</medicinalproduct>
        <drugdosagetext>100MG PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100322</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138305-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RU-ROCHE-744137</companynumb>
    <primarysource>
      <reportercountry>RUSSIAN FEDERATION</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>LAST DOSE PRIOR TO SAE 28 OCT 2010.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090814</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON ALFA-2A</medicinalproduct>
        <drugdosagetext>DOSE: 3 MME, LAST DOSE PRIOR TO SAE 12 NOV 2010.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090814</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138306-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033734</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>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138307-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ROCHE-744268</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUBILEUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>FORM: INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>FREQUENCY: DAILY, TEMPORARILY INTERRUPTED.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPAMIDA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANDRAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IDALPREM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADIRO</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138308-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GENZYME-FLUD-1000445</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER DISSEMINATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020038</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PERIPHERAL T-CELL LYMPHOMA UNSPECIFIED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PERIPHERAL T-CELL LYMPHOMA UNSPECIFIED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MITOXANTRONE HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PERIPHERAL T-CELL LYMPHOMA UNSPECIFIED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138309-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENZYME-CLOF-1001208</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87.075</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR LYSIS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOLAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021673</drugauthorizationnumb>
        <drugdosagetext>42 MG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100914</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugdosagetext>800 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugdosagetext>60 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>POLYCYTHAEMIA VERA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19961001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>0.25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>25 MG, BID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDREA</medicinalproduct>
        <drugdosagetext>500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYCYTHAEMIA VERA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugdosagetext>10 MG, PRN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugindication>VOMITING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
        <drugdosagetext>2 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100914</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138310-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-744454</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACLIZUMAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138311-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>EC-ROCHE-744819</companynumb>
    <primarysource>
      <reportercountry>ECUADOR</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOTRETINOIN</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>FREQUENCY: QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE CONGLOBATA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100507</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138312-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-744855</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugauthorizationnumb>050585</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugauthorizationnumb>050585</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BRISTOPEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERSYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARDEGIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDENSIEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138313-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ROCHE-744863</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2A</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2A</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100921</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138314-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ROCHE-744911</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>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO CENTRAL NERVOUS SYSTEM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>THIS IS THE LOADING DOSE.</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138315-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033994</companynumb>
    <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>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100702</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138316-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-745148</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS CLOSTRIDIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ADENOCARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOLFIRI REGIMEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ADENOCARCINOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138317-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20100505210</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANKLE OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138318-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20101103416</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAELYX</medicinalproduct>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugdosagetext>5TH LINE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FASLODEX</medicinalproduct>
        <drugdosagetext>5TH LINE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISPHOSPHONATES</medicinalproduct>
        <drugdosagetext>5TH LINE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138321-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033966</companynumb>
    <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 PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091221</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138322-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-745316</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>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138323-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-AMGEN-ARGSP2010003768</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>T4</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138324-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-745336</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>5-FU</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138325-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060602</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-745955</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138330-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55.79</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-SMALL CELL LUNG CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugdosagetext>PEMETREXED EVERY 21 DAYS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB</medicinalproduct>
        <drugdosagetext>ERLOTINIB QD FOR 19 DAYS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXPRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUCOSATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN AMOXICILLIN-CLAVULANATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EX GEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138332-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-745454</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>HERCEPTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138333-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-ROCHE-745500</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100921</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138334-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080901</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-745504</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>AVASTIN</medicinalproduct>
        <drugdosagetext>DOSE, FORM AND FREQUENCY NOT PROVIDED.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>ROUTE, DOSE, FORM AND FREQUENCY NOT PROVIDED.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138335-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033832</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>121.22</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COR PULMONALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101123</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138336-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061219</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-745613</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138338-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-745746</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3</patientweight>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HETEROTAXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OSELTAMIVIR</medicinalproduct>
        <drugauthorizationnumb>021087</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>INFLUENZA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138339-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-ROCHE-745777</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICHEW D3 FORTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIMOVANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRUSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138340-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-745794</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>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ODYNOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGFILGRASTIM</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100510</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPLATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100524</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138341-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ROCHE-745798</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>FREQUENCY: DAY 1 EVERY 21 DAYS.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugdosagetext>FREQUENCY: DAY 1 EVERY 21 DAYS.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>FREQUENCY: DAY 1 EVERY 21 DAYS.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYNORM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPAVAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXOFEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOLLIPECT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXASCAND</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELOKEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TROMBYL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101018</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138342-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2010IT13282</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>1.42</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL NOSE MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSMORPHISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOPHTHALMOS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTELORISM OF ORBIT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTONIA NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERY STENOSIS CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIGHT AORTIC ARCH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE (NGX)</medicinalproduct>
        <drugauthorizationnumb>075566</drugauthorizationnumb>
        <drugdosagetext>5 MG/DAY DURING THE FIRST 2 MONTHS OF GESTATION (MATERNAL DOSE)</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE (NGX)</medicinalproduct>
        <drugauthorizationnumb>075566</drugauthorizationnumb>
        <drugdosagetext>20 MG/DAY FOR THE PRECEDING THREE WEEKS OF GESTATION (MATERNAL DOSE)</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138343-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2010BR13349</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugauthorizationnumb>078528</drugauthorizationnumb>
        <drugdosagetext>1 MG MATERNAL DOSE</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138344-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2010US13305</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMINO ACID METABOLISM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN HERNIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERAMMONAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DIET</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID (NGX)</medicinalproduct>
        <drugauthorizationnumb>078290</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI-THYMOCYTE GLOBULIN NOS</medicinalproduct>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIFUNGALS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138345-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2010KW13321</companynumb>
    <primarysource>
      <reportercountry>KUWAIT</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>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARROW HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>720 MG/M2 (CUMULATIVE DOSE)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN (NGX)</medicinalproduct>
        <drugdosagetext>450 MG/M2 (CUMULATIVE DOSE)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE (NGX)</medicinalproduct>
        <drugauthorizationnumb>090029</drugauthorizationnumb>
        <drugdosagetext>144 G/M2 (CUMULATIVE DOSE)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138346-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2010IT13284</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>1.25</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL NOSE MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSMORPHISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOTRACHEAL INTUBATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOPHTHALMOS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTELORISM OF ORBIT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTONIA NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERY STENOSIS CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINGLE UMBILICAL ARTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE (NGX)</medicinalproduct>
        <drugauthorizationnumb>075566</drugauthorizationnumb>
        <drugdosagetext>5 MG/DAY DURING THE FIRST 2 MONTHS OF GESTATION (MATERNAL DOSE)</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE (NGX)</medicinalproduct>
        <drugauthorizationnumb>075566</drugauthorizationnumb>
        <drugdosagetext>20 MG/DAY LAST THREE WEEKS OF GESTATION (MATERNAL DOSE)</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138347-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201010007213</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>79.365</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC PROCEDURE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugbatchnumb>A697382A</drugbatchnumb>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugdosagetext>60 MG, LOADING DOSE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>STENT PLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101002</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANGIOMAX</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138348-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-745872</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOWER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080904</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081030</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081225</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090319</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090417</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090515</drugenddate>
      </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>20090710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090710</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090807</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>FORM:PERORAL AGENT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080723</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080724</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>FORM: PERORAL AGENT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081127</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCALTROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIAMIN</medicinalproduct>
        <drugdosagetext>PER ORAL AGENT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugdosagetext>PERORAL AGENT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>PERORAL AGENT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138352-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>91.6266</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>ONE TAB 1 TO 2 DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138355-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2010GB13336</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>LARGE CELL CARCINOMA OF THE RESPIRATORY TRACT STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE (NGX)</medicinalproduct>
        <drugauthorizationnumb>090029</drugauthorizationnumb>
        <drugdosagetext>30 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138356-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2010ES12406</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTINUOUS HAEMODIAFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYDIPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSFERRIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugauthorizationnumb>075985</drugauthorizationnumb>
        <drugdosagetext>850 MG, TID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORASEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACENOCOUMAROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORMETAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIOTROPIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN GLARGINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERBUTALINE SULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138357-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2010GB13300</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>HAEMORRHAGIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugauthorizationnumb>040772</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100617</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOLINIC ACID (NGX)</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100617</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>350 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100812</drugenddate>
        <drugtreatmentduration>57</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100617</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138358-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201011002884</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>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADCIRCA</medicinalproduct>
        <drugauthorizationnumb>021368</drugauthorizationnumb>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>30 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101024</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138359-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-745893</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 IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138360-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXBR2010US01800</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>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN AND CLAVULANATE POTASSIUM</medicinalproduct>
        <drugauthorizationnumb>065063</drugauthorizationnumb>
        <drugdosagetext>875/125MG BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101003</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138361-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2010IT13381</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PERIORBITAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBARACHNOID HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugauthorizationnumb>070268</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138362-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2010GB13335</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALENDRONIC ACID (NGX)</medicinalproduct>
        <drugauthorizationnumb>075871</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101015</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADCAL-D3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIMATOPROST AND TIMOLOL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138363-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2010GB11222</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>91</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE (NGX)</medicinalproduct>
        <drugauthorizationnumb>065032</drugauthorizationnumb>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE (NGX)</medicinalproduct>
        <drugauthorizationnumb>065032</drugauthorizationnumb>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100422</drugenddate>
        <drugtreatmentduration>366</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE (NGX)</medicinalproduct>
        <drugauthorizationnumb>065032</drugauthorizationnumb>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100422</drugenddate>
        <drugtreatmentduration>366</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE (NGX)</medicinalproduct>
        <drugauthorizationnumb>065032</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090423</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>12 IU, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060303</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>125 UG, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090513</drugenddate>
        <drugtreatmentduration>1039</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>22 IU, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090513</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060710</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138364-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2010DE11511</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>140</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugauthorizationnumb>076859</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE AND VALSARTAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100804</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138365-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2010-41789</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>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 125 MG US</medicinalproduct>
        <drugbatchnumb>EP072P0102</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 125 MG US</medicinalproduct>
        <drugbatchnumb>EP072P0102</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 125 MG US</medicinalproduct>
        <drugbatchnumb>EP072P0102</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138366-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100312</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0034007</companynumb>
    <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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100219</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138367-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>NZ-ROCHE-745950</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>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOTRETINOIN</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SKIN DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138368-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-ROCHE-745951</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>3</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>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101013</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138369-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>NZ-ROCHE-745952</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>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOTRETINOIN</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SKIN DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138370-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-746040</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>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>FREQUENCY:DAY 1 EVERY 21 DAYS. DATE OF LAST DOSE PRIOR TO SAE:16 MARCH 2009</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPOTECAN</medicinalproduct>
        <drugdosagetext>FREQUENCY:DAYS 1-5 FOR 5 CONSECUTIVE DAYS.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM/VITAMIN D3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138372-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ACTELION-A-CH2010-37390</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY VENO-OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOPROSTENOL SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMATINIB</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMATINIB</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138373-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080625</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-745387</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO CENTRAL NERVOUS SYSTEM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138374-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10113082</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>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138375-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-745668</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138376-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-745707</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138377-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10111801</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 LYMPHOCYTIC LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101029</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138378-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070806</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-745708</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138379-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033975</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>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138380-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090611</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-745735</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</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>HERCEPTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138381-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>40.8237</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOUS STOOLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugdosagetext>2 TABS ONCE A DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101130</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138384-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7194</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER DUE TO GENERAL MEDICAL CONDITION, INSOMNIA TYPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugdosagetext>10 MG 1XDAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SEASONAL ALLERGY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101126</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138388-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10113079</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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081217</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138389-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-ROCHE-745768</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</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>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021858</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138390-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-745781</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090506</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPOTECAN</medicinalproduct>
        <drugdosagetext>FIRST CYCLE: 2.3 MG/M2,SWECOND CYCLE 1.9 MG/M2 AND 3RD CYCLE 1.5 MG/M2 FOR 5 CONSECUTIVE DAYS.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090506</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESILATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELATONIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARBEPOETIN ALFA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLYSACCHARIDE-IRON COMPLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138391-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ROCHE-745908</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>DOSE, FORM, FREQUENCY, ROUTE: NOT REPORTED.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138392-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033969</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101021</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138393-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.1834</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugdosagetext>500MG 1/DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101130</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138394-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>113.3993</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HCL AND ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>EVERY 6 HOURS FOR PAIN IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>POSTOPERATIVE ANALGESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138395-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-BAXTER-2010BH029021</companynumb>
    <primarysource>
      <reportercountry>POLAND</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</medicinalproduct>
        <drugbatchnumb>10J14G43</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>10I17G40</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138396-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>54.4316</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPERSONALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUNGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugdosagetext>2 TABLETS DAY 3</drugdosagetext>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100912</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138397-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-CELGENEUS-087-21880-10091212</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100810</drugenddate>
        <drugtreatmentduration>40</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100826</drugenddate>
        <drugtreatmentduration>40</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100921</drugenddate>
        <drugtreatmentduration>40</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101017</drugenddate>
        <drugtreatmentduration>40</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LENADEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100809</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LENADEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100816</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LENADEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100824</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LENADEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100921</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100826</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100908</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138398-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>86.1834</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CONTRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL HERPES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPLIN 15 MG NOT ON LABEL</medicinalproduct>
        <drugbatchnumb>NOT ON BOTTLE</drugbatchnumb>
        <drugdosagetext>15 MG ONCE PER DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugdosagetext>20 MG ONCE PER DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138399-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROTISING FASCIITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>10-15 MG/KG EVERY 14 DAYS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FALLOPIAN TUBE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100809</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138403-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PERRIGO-10US015113</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>ACUTE HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PH DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROMECHANICAL DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROPOFOL INFUSION SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN SLOW RELEASE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>075077</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1.89 GM OVER 17 HOURS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138405-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10111689</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>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISMO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEOSOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138406-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAXTER-2010BH027923</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL PD-2 W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138407-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10081187</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138408-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201009000011</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>41.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TADALAFIL</medicinalproduct>
        <drugauthorizationnumb>021368</drugauthorizationnumb>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100807</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DORNER</medicinalproduct>
        <drugdosagetext>40 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100807</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138409-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201008007783</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>
      <patientweight>53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>760 MG, OTHER</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA STAGE III</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091117</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>760 MG, OTHER</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091208</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>760 MG, OTHER</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100105</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANVITAN</medicinalproduct>
        <drugdosagetext>1 G, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100130</drugenddate>
        <drugtreatmentduration>83</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXOCOBALAMIN ACETATE</medicinalproduct>
        <drugdosagetext>1 MG, OTHER</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091110</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXOCOBALAMIN ACETATE</medicinalproduct>
        <drugdosagetext>1 MG, OTHER</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100112</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091118</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091208</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100105</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROTONE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091117</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROTONE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091208</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROTONE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100105</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</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>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091209</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100104</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100106</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN, STARTED BEFORE THE START OF PEMETREXED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DECREASED APPETITE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100313</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER D /JPN/</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN, STARTED BEFORE THE START OF PEMETREXED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100313</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN, STARTED BEFORE THE START OF PEMETREXED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100313</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGLAX /JPN/</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN, STARTED BEFORE THE START OF PEMETREXED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100313</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN, STARTED BEFORE THE START OF PEMETREXED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100313</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN, STARTED BEFORE THE START OF PEMETREXED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100313</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVAMIN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN, STARTED BEFORE THE START OF PEMETREXED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100313</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPALMON</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN, STARTED BEFORE THE START OF PEMETREXED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100313</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN, STARTED BEFORE THE START OF PEMETREXED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100313</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN, STARTED BEFORE THE START OF PEMETREXED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100313</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUROTEP</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN, STARTED BEFORE THE START OF PEMETREXED</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100313</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138410-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201010000251</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.188</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GILBERT'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBILIRUBINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR COMPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HCL</medicinalproduct>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugdosagetext>1930 MG, DAYS 1, 8 AND 15</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100923</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OTHER PHARMA COMPANY INV DRUG</medicinalproduct>
        <drugdosagetext>100 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100919</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>145 MG, DAYS 1, 8 AND 15</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100923</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CREON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138411-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ELI_LILLY_AND_COMPANY-GB201011006459</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>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HCL</medicinalproduct>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugdosagetext>2204 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>430 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OTHER PHARMA COMPANY INV DRUG</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYNORM</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON HCL</medicinalproduct>
        <drugdosagetext>3 MG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>8 MG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138412-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011006430</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>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OTHER PHARMA COMPANY INV DRUG</medicinalproduct>
        <drugdosagetext>UNK, 2 IN 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138413-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011006710</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>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAILURE TO THRIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HCL</medicinalproduct>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugdosagetext>1000 MG/M2, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101121</drugenddate>
        <drugtreatmentduration>41</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>125 MG/M2, WEEKLY (1/W)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101121</drugenddate>
        <drugtreatmentduration>41</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>1-2 TABS Q4 AS NEEDED</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDASETRON</medicinalproduct>
        <drugdosagetext>8 MG EVERY 6 HRS, AS NEEDED</drugdosagetext>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE</medicinalproduct>
        <drugdosagetext>975 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100805</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
        <drugdosagetext>25 MG, AS NEEDED AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100905</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100905</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARINOL</medicinalproduct>
        <drugindication>APPETITE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138414-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201009004140</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.361</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>500 MG/M2, ON DAY 1 EVERY 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100609</drugenddate>
        <drugtreatmentduration>78</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>281.3 MG/M2, ON DAY 1 EVERY 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100714</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>6 AUC, ON DAY 1 EVERY 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100609</drugenddate>
        <drugtreatmentduration>78</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>15 MG/KG, ON DAY ONE EVERY 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100609</drugenddate>
        <drugtreatmentduration>78</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>15 MG/M2, OTHER (DAY ONE EVERY 21 DAYS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100804</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100317</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100422</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100825</drugenddate>
        <drugtreatmentduration>148</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMLA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100317</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY EMBOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100317</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>2.5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100825</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>DYSPNOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugindication>DYSPNOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100331</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100324</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100324</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugindication>ISCHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugindication>HYPOMAGNESAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100609</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
        <drugindication>DIZZINESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100609</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugindication>DECREASED APPETITE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100324</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138415-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE201011006332</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>500 MG/M2, EVERY 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>75 MG/M2, EVERY 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138417-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011000783</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>136.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRASUGREL HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugdosagetext>60 MG, ONCE</drugdosagetext>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRASUGREL HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101015</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIPLATELET THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugdosagetext>5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>80 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugdosagetext>8000 U, OTHER</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101011</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138418-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-ELI_LILLY_AND_COMPANY-IN200805000536</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ALKALOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HCL</medicinalproduct>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugdosagetext>1000 MG/M2, OTHER DAY 1+8 EVERY 3 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080326</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINFLUNINE</medicinalproduct>
        <drugdosagetext>320 MG/M2, OTHER DAY ONE EVERY 3 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080326</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080326</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080402</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SETRON</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080326</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SETRON</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080402</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080326</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080402</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080401</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080406</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RINGER'S</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080326</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RINGER'S</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080402</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTRAPID HUMAN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080326</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISPHOSPHONATES</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080327</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUPHALAC</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080408</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138419-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ELI_LILLY_AND_COMPANY-AU201009001950</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HCL</medicinalproduct>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugdosagetext>1000 MG/M2, OTHER</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100915</drugenddate>
        <drugtreatmentduration>126</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HCL</medicinalproduct>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugdosagetext>REDUCED DOSE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>125 MG/M2, OTHER</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100915</drugenddate>
        <drugtreatmentduration>126</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>REDUCED DOSE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOMIX                            /01475801/</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLLIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLOXYL WITH SENNA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100729</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138420-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ELI_LILLY_AND_COMPANY-IT201012000066</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>500 MG/M2, OTHER</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEAD AND NECK CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>400 MG/M2, ONCE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEAD AND NECK CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>250 MG/M2, WEEKLY (1/W)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>75 MG/M2, EVERY 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEAD AND NECK CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101123</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138421-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011005345</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAPUBIC PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRASUGREL HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugdosagetext>10 MG, ONCE</drugdosagetext>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100527</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRASUGREL HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100527</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>40 MG, 2/D</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100527</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100527</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100527</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>0.5 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugdosagetext>40 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>40 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138425-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-CARDIAC CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUNE GLOBULIN NOS</medicinalproduct>
        <drugdosagetext>35 GM ONCE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101015</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138427-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10102397</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>95.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD FIBRINOGEN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100830</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100828</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101115</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101115</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138428-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-ABBOTT-10P-009-0685818-00</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</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>CEREBRAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA ALZHEIMER'S TYPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRENANTONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020708</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138429-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10120267</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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138430-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-CEPHALON-2010006143</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TREANDA</medicinalproduct>
        <drugauthorizationnumb>022249</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080903</drugenddate>
        <drugtreatmentduration>300</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TREANDA</medicinalproduct>
        <drugauthorizationnumb>022249</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080903</drugenddate>
        <drugtreatmentduration>300</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TREANDA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080903</drugenddate>
        <drugtreatmentduration>300</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080903</drugenddate>
        <drugtreatmentduration>200</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080903</drugenddate>
        <drugtreatmentduration>200</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138431-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028595</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</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138432-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2010GB05507</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BENIGN NEOPLASM</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>20090112</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138433-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US79433</companynumb>
    <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>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138434-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US80075</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>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugdosagetext>4.6 MG, UNK</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATIONS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138435-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010NL76873</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 EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL ARTERIAL OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL REVASCULARISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugdosagetext>6 MG, BID</drugdosagetext>
        <drugindication>DEMENTIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMINYL                                 /UNK/</medicinalproduct>
        <drugdosagetext>16 MG PER TIME</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAXIPARINE</medicinalproduct>
        <drugdosagetext>2 DF PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEDOCARD</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELOKEEN</medicinalproduct>
        <drugdosagetext>95 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugdosagetext>3 MG (3 TABLETS) PER TIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEFZOL</medicinalproduct>
        <drugdosagetext>1DF PER TIME</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138436-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US80092</companynumb>
    <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>ILLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138437-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010DE80573</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RALES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LMF237 LMF237+</medicinalproduct>
        <drugdosagetext>1 DF (850/50 MG), BID</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LMF237 LMF237+</medicinalproduct>
        <drugdosagetext>1 DF (1000/50 MG), BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RASILEZ</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>1 DF (150 MG), QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RASILEZ</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>1 DF (300 MG), QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>1DF, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXFORGE</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEBIVOLOL</medicinalproduct>
        <drugdosagetext>1 DF, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BERODUAL</medicinalproduct>
        <drugdosagetext>PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAC DIAGNOSTIC REAGENT</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugdosagetext>PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>1 DF (12.5 (UNSPECIFIED UNITS)), QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOREM</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138438-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP80534</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</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>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100728</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100824</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101104</drugenddate>
        <drugtreatmentduration>66</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUFAN</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100714</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KREMEZIN</medicinalproduct>
        <drugdosagetext>2 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100714</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOHRUS TAPE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100714</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138439-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US05483</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92.517</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AZOTAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRODUODENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGAMMAGLOBULINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNODEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTOSE INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGHT CHAIN ANALYSIS INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOCTURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ODYNOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL SPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGOGASTRODUODENOSCOPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL HERPES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERWEIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STREPTOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPERIOR VENA CAVAL OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBULOINTERSTITIAL NEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENA CAVA THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>90MG EVERY MONTH</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>MONTHLY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>2.5MG DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugdosagetext>7.5MG AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>10MG AT BEDTIME</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>20MG AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>20 MEQ DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
        <drugdosagetext>30MG TWICE DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHROMAGEN</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT                            /00909301/</medicinalproduct>
        <drugdosagetext>40, 000 UNITS WEEKLY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT                                 /UNK/</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugdosagetext>50 MCG, EVERY 72 HOURS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugdosagetext>500 MG DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugdosagetext>40 MG, AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR</medicinalproduct>
        <drugdosagetext>20 MEQ DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>0.5MG, ONE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
        <drugdosagetext>UNK,</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEPTRA DS</medicinalproduct>
        <drugdosagetext>UNK, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INTERFERON</medicinalproduct>
        <drugdosagetext>3,000,000 UNITS THREE TIMES A WEEK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugdosagetext>250 MG, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOMOTIL</medicinalproduct>
        <drugdosagetext>5 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL ^PFIZER WARNER-LAMBERT^</medicinalproduct>
        <drugdosagetext>25 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugdosagetext>1 MG, QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
        <drugdosagetext>5 ML</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
        <drugdosagetext>PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORHEXIDINE GLUCONATE</medicinalproduct>
        <drugdosagetext>15 ML, Q12H</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugdosagetext>200 MG, Q12H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLOPRIM</medicinalproduct>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN ^AVENTIS PHARMA^</medicinalproduct>
        <drugdosagetext>25 MG, Q6H</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>20 MG, PRN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERIDEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugdosagetext>24 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>650 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugdosagetext>172 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE</medicinalproduct>
        <drugdosagetext>100 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTAZOCINE LACTATE</medicinalproduct>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPIN</medicinalproduct>
        <drugdosagetext>PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMETHICONE</medicinalproduct>
        <drugdosagetext>PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICYCLOMINE</medicinalproduct>
        <drugdosagetext>PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FILGRASTIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138440-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10120193</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>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138441-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP81484</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>600 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138442-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010IT76324</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100908</drugenddate>
        <drugtreatmentduration>769</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugindication>METASTASES TO BONE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138443-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2008AR37245</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MADOPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIDOSOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CABASER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138444-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010IT76301</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG MONTHLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100920</drugenddate>
        <drugtreatmentduration>873</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138445-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010IN81389</companynumb>
    <primarysource>
      <reportercountry>INDIA</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>GLIVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>600 MG, UNK</drugdosagetext>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138446-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010FR17847</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>103</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN NEOPLASM EXCISION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FTY 720 FTY+</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOSMINE</medicinalproduct>
        <drugindication>SENSATION OF HEAVINESS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138447-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP72717</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC DIATHESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IDIOPATHIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMULECT</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMULECT</medicinalproduct>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DENOSINE ^FAREAST^</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CYTOMEGALOVIRUS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANULOCYTE COLONY STIMULATING FACTOR</medicinalproduct>
        <drugdosagetext>800/?L OF WBC COUNT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALGANCICLOVIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138448-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010IT68047</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugauthorizationnumb>050573</drugauthorizationnumb>
        <drugdosagetext>66 MG/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100915</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138449-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2009CA40915</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG LOBECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138450-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010IT17919</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED ALISKIREN ALI+TAB+CF</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>CODE NOT BROKEN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101022</drugenddate>
        <drugtreatmentduration>57</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>CODE NOT BROKEN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101022</drugenddate>
        <drugtreatmentduration>57</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED NO TREATMENT RECEIVED NOMED</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>CODE NOT BROKEN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101022</drugenddate>
        <drugtreatmentduration>57</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMPARATOR ENALAPRIL</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100707</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMPARATOR ENALAPRIL</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100827</drugenddate>
        <drugtreatmentduration>52</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALISKIREN</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100827</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138451-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD</medicinalproduct>
        <drugdosagetext>100 GM DAILY X3 IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BONE MARROW FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100914</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138452-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2009CA17701</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CACHEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WAIST CIRCUMFERENCE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>60 MG, EVERY 2 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CARCINOID TUMOUR OF THE PANCREAS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugindication>METASTATIC CARCINOID TUMOUR</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138453-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010RU81157</companynumb>
    <primarysource>
      <reportercountry>RUSSIAN FEDERATION</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>GASTROINTESTINAL NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG DIALY</drugdosagetext>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138454-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2009CA56295</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN OF SKIN</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>20011220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050930</drugenddate>
        <drugtreatmentduration>1381</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPEUTICS NOS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100623</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138455-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010IT76326</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG ADENOCARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CAVITY FISTULA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091001</drugenddate>
        <drugtreatmentduration>519</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugindication>METASTASES TO BONE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138456-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US05991</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>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTATIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIODONTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRIMARY SEQUESTRUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugdosagetext>2.5MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FASLODEX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIORINAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138457-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010NL17467</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IMPLANTABLE DEFIBRILLATOR INSERTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED ALISKIREN ALI+TAB+CF</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>NO TREATMENT</drugdosagetext>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>NO TREATMENT</drugdosagetext>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED NO TREATMENT RECEIVED NOMED</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>NO TREATMENT</drugdosagetext>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMPARATOR ENALAPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALISKIREN</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138458-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010DE79691</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138459-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010IT76322</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100713</drugenddate>
        <drugtreatmentduration>925</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138460-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2009DE02054</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TACHYARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONATE T29581+SOLINJ+BM</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138461-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010IL79961</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>30 MG EVERY 28 DAYS</drugdosagetext>
        <drugindication>CARCINOID TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090120</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138462-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP69045</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DIASTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090618</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN R</medicinalproduct>
        <drugdosagetext>20 IU</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091015</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138463-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010MX80260</companynumb>
    <primarysource>
      <reportercountry>MEXICO</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>DIOVAN HCT</medicinalproduct>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugdosagetext>1 TABLET (160/25MG) DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138464-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010IT68049</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugauthorizationnumb>050573</drugauthorizationnumb>
        <drugdosagetext>66 MG DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100915</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138465-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR80475</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 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugbatchnumb>UNK.</drugbatchnumb>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138466-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA17484</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARATHYROIDECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>30 MG, EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ACROMEGALY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070905</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138467-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA65351</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>30 MG, QMO</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CARCINOID TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090515</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138468-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP68714</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>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C RNA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMULECT</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>LIVER TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugindication>LIVER TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugindication>LIVER TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138469-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR34944</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>
      <patientweight>86</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELMAC</medicinalproduct>
        <drugauthorizationnumb>021200</drugauthorizationnumb>
        <drugdosagetext>1 DF, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABLOK PLUS</medicinalproduct>
        <drugdosagetext>1 TABLET PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138470-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BE43841</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHERGINE</medicinalproduct>
        <drugauthorizationnumb>006035</drugauthorizationnumb>
        <drugdosagetext>7 X 15 DROPS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100706</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138471-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CN82023</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>
      <patientweight>67</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138472-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010IN81978</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>GLIVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138473-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010DE50723</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN NATRIURETIC PEPTIDE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RASILEZ HCT</medicinalproduct>
        <drugauthorizationnumb>022107</drugauthorizationnumb>
        <drugdosagetext>ONE DOSAGE FORM (300/12.5 MG) DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100811</drugenddate>
        <drugtreatmentduration>84</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090204</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138474-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010CA18310</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>10 MG / DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101123</drugenddate>
        <drugtreatmentduration>69</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138475-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010IN81398</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>GLIVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>600 MG</drugdosagetext>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138476-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US53180</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALCOHOLIC LIVER DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN</medicinalproduct>
        <drugauthorizationnumb>019667</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>POST GASTRIC SURGERY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN</medicinalproduct>
        <drugauthorizationnumb>019667</drugauthorizationnumb>
        <drugdosagetext>400 UG, TID</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN</medicinalproduct>
        <drugauthorizationnumb>019667</drugauthorizationnumb>
        <drugdosagetext>400 MG, TID</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
        <drugdosagetext>25 MG, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
        <drugdosagetext>10 MG, HS</drugdosagetext>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325 MG, 2 TABLETS HS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBYAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>40 MG, BID</drugdosagetext>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>25 MG, BID</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138477-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010CN18273</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALPHA HAEMOLYTIC STREPTOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONCOMITANT DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>10 MG / DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100914</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138478-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR40146</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>DIABETIC COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BLADDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO GASTROINTESTINAL TRACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO KIDNEY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO PANCREAS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTATIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>1 TABLET, A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugdosagetext>1 TABLET (40 MG), A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANGIPRESS</medicinalproduct>
        <drugdosagetext>1 TABLET (100 MG), A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugdosagetext>30 IU, A DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138479-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010162755</companynumb>
    <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>DEPO-PROVERA</medicinalproduct>
        <drugauthorizationnumb>012541</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138480-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2010163452</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138481-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-PFIZER INC-2010160163</companynumb>
    <primarysource>
      <reportercountry>NORWAY</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>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYCYTHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>50 MG, TWO CYCLES (4 WEEKS ON, 2 WEEKS OFF)</drugdosagetext>
        <drugindication>RENAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1 CYCLE (4 WEEKS ON, TWO WEEKS OFF)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>37.5 MG, NUMBER OF CYCLUSES (4 WEEKS ON, 2 WEEKS OFF)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>25 MG/DAY (TOTALLY 16 CYCLUSES, LAST ONE STARTED MAY2009)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138482-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010162054</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>019787</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138483-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2010163025</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYCOSIS FUNGOIDES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
        <drugauthorizationnumb>020987</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>020987</drugauthorizationnumb>
        <drugdosagetext>20 MG, ALTERNATE DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138484-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010162940</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugdosagetext>0.2 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138485-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RU-PFIZER INC-2010163222</companynumb>
    <primarysource>
      <reportercountry>RUSSIAN FEDERATION</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>ASPHYXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>200 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138486-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010141184</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FEELING ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100819</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138487-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028939</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>CALCIPHYLAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101109</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138491-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2010SE36546</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>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEAL PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>021399</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138492-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2010162183</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugauthorizationnumb>011856</drugauthorizationnumb>
        <drugdosagetext>40MG/2ML</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZANTAC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugdosagetext>1 DF</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL</medicinalproduct>
        <drugdosagetext>0.5 DF, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
        <drugdosagetext>1 DF</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138493-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161966</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERIAL STENT INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CADUET</medicinalproduct>
        <drugauthorizationnumb>021540</drugauthorizationnumb>
        <drugdosagetext>10/20, MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugindication>ARTERIAL OCCLUSIVE DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>325 MG, 1X/DAY</drugdosagetext>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>UNK MG, 2X/DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
        <drugdosagetext>60 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugdosagetext>48 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>150 MG, 2X/DAY</drugdosagetext>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>1200 MG, 1X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138494-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161829</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>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138495-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2010SE56708</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>CARDIAC FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>021399</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138496-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2010SE56508</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>680</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENTOCORT EC</medicinalproduct>
        <drugauthorizationnumb>021324</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AUTOIMMUNE HEPATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMUREL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AUTOIMMUNE HEPATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRETERAX</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138497-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028958</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101125</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138498-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0034050</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>LEFT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100708</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138500-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>W9A11</drugbatchnumb>
        <drugdosagetext>40MG Q8? PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138502-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>91.173</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APRAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CENTRAL NERVOUS SYSTEM LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138503-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.3075</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INADEQUATELY CONTROLLED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT SUBSTITUTION ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugdosagetext>CLONIDINE 0.3MG/__  OF WEEK TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugdosagetext>CLONIDINE 0.3MG/__  OF WEEK TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>HYPERTENSIVE CARDIOMYOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIPLE ORAL DRUGS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE PATCHES</medicinalproduct>
        <drugdosagetext>0.3MG/__ TRANSDERMAL</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE PATCHES</medicinalproduct>
        <drugdosagetext>0.3MG/__ TRANSDERMAL</drugdosagetext>
        <drugindication>HYPERTENSIVE CARDIOMYOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138506-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.514</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HCL AND ACETAMINOPHEN</medicinalproduct>
        <drugbatchnumb>93</drugbatchnumb>
        <drugdosagetext>1   4 HOURS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138508-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSON'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>50 MG THREE TIMES DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITIZA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138509-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.3273</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED WITH DRUG SUBSTITUTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GIANVI 3 MG 10 OZ MG TEVA</medicinalproduct>
        <drugbatchnumb>702861</drugbatchnumb>
        <drugdosagetext>1 QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENORRHAGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138510-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-AMGEN INC.-KDC425904</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RENAL NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>50 MG, Q2WK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080118</drugenddate>
        <drugtreatmentduration>103</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugdosagetext>45 MG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100504</drugenddate>
        <drugtreatmentduration>85</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVALIDE</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRALEX</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071031</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOVOBET</medicinalproduct>
        <drugdosagetext>UNK UNK, PRN</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138511-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101201611</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138512-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20100504578</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>100</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugdosagetext>3.5 PILLS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138513-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-BAXTER-2010BH027449</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BURKITT'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BURKITT'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BURKITT'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BURKITT'S LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138514-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-PFIZER INC-2010131721</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugauthorizationnumb>019949</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYGACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAZOCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISEPTOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138515-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH029038</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138516-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>58.9676</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IRIDOCYCLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRIS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRIS TRANSILLUMINATION DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugdosagetext>1 DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100219</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138517-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.6579</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT SUBSTITUTION ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138518-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.5755</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TINDAMAX</medicinalproduct>
        <drugbatchnumb>X100363B</drugbatchnumb>
        <drugdosagetext>500MG X2 ONCE A DAY PO (TOOK 1 DOSE ONLY)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VAGINITIS BACTERIAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138520-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.1115</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>AMLODIPINE 5G 1PO QD PO -047</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENAZEPRIL</medicinalproduct>
        <drugdosagetext>BENAZEPRIL 10MG 1 QD PO - 047</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138522-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TROPONIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138525-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>LEBANON</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SCOBUREN 20 MG/ML RENAUDIN/MINAPHARM HALABI</medicinalproduct>
        <drugbatchnumb>3119</drugbatchnumb>
        <drugdosagetext>20 MG/ML ONCE PER DAY IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN UPPER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090515</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138526-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>79.8331</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL EXTENDED-RELEASE</medicinalproduct>
        <drugdosagetext>1 CAPSULE DAILY BY MOUTH</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL EXTENDED-RELEASE</medicinalproduct>
        <drugdosagetext>1 CAPSULE DAILY BY MOUTH</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC ATTACK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101129</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138528-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH029039</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>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138529-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-10P-028-0688317-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FAECAL VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>FIRST WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138530-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-10P-056-0687881-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138531-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ABBOTT-10P-008-0683433-00</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</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>PREDNISOLONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138532-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ACTELION-A-CH2007-17205</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>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>65 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051202</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>31.25 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOPROSTENOL SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BERAPROST SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBAMIPIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUCRALFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUNITRAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOTIAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138534-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US78983</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>117</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>2250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LYMPHOPROLIFERATIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SERUM FERRITIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>2250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100719</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138535-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HODGKIN'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MERCAPTOPURINE</medicinalproduct>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138536-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2008US05797</companynumb>
    <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>ARTERIOVENOUS MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugauthorizationnumb>021200</drugauthorizationnumb>
        <drugdosagetext>6 MG 1/2 TAB 2 TIMES DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL DISCOMFORT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>10 MG BY MOUTH DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>50 MG TABLETS 2 TIMES DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLTX</medicinalproduct>
        <drugdosagetext>1 TAB BY MOUTH DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugdosagetext>100 MG BY MOUTH DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40 MG BY MOUTH DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DELATESTRYL</medicinalproduct>
        <drugdosagetext>200 MG/ML IM EVERY 2 WEEKS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>40 MG BY MOUTH DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugdosagetext>0.4 MG SL 1 EVERY 5 MINUTES X 3</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>SLIDING SCALE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugdosagetext>7.5 BY MOUTH AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugdosagetext>25 MG AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN-D</medicinalproduct>
        <drugdosagetext>10 MG BY MOUTH AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>25 UNITS EVERY MORNING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR HCT</medicinalproduct>
        <drugdosagetext>100 MG BY MOUTH 2 TIMES DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138537-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2010US03871</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugauthorizationnumb>021200</drugauthorizationnumb>
        <drugindication>GASTROINTESTINAL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVALIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138538-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2010GB05691</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>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RESISTANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL STROMAL TUMOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENE MUTATION IDENTIFICATION TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMATINIB</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMATINIB</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>800 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUNITINIB MALATE</medicinalproduct>
        <drugdosagetext>50 MG</drugdosagetext>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138539-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201011004953</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>500 MG/M2, OTHER</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANVITAN</medicinalproduct>
        <drugdosagetext>1 G, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugdosagetext>1 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROTONE</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
        <drugdosagetext>8 MG, UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIART</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugdosagetext>8 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100428</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELARA</medicinalproduct>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTERIOSCLEROSIS CORONARY ARTERY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101029</drugenddate>
        <drugtreatmentduration>355</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVALO</medicinalproduct>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICON</medicinalproduct>
        <drugdosagetext>45 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE PHOSPHATE                  /00012602/</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101026</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138540-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR201011005674</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</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>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugdosagetext>1250 MG/M2, 21DAY CYCLE ON DAY1 AND 8</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100311</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLUPRED</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>0.25 MG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100311</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugdosagetext>UNK, 1TAB/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100311</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138541-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201008008221</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>INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION</reactionmeddrapt>
      </reaction>
      <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>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>75 MG/M2, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138542-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BD-ELI_LILLY_AND_COMPANY-BD201012000575</companynumb>
    <primarysource>
      <reportercountry>BANGLADESH</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugbatchnumb>A664391E</drugbatchnumb>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>500 MG/M2, UNK</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100429</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138543-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201008004591</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>
      <patientweight>81.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XIGRIS</medicinalproduct>
        <drugdosagetext>24 UG/KG, EVERY HOUR</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100816</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138544-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201010001795</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>39.909</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugdosagetext>1 D/F, UNK</drugdosagetext>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugdosagetext>800 MG/M2, WEEKLY (1/W)</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100924</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138545-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201011007018</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101028</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101028</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138546-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>100.2449</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
        <drugdosagetext>WELLBUTRIN XL 150 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101030</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138547-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011002828</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>
      <patientweight>47.166</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY TOXIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>500 MG/M2, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100920</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100920</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138548-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR201011005925</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYSIPELOID</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100903</drugenddate>
        <drugtreatmentduration>131</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROPINIROLE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>2 MG, 2/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETIMIBE/SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPRONIZINE</medicinalproduct>
        <drugdosagetext>2 AT NIGHT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TELMISARTAN AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>80 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138550-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.7194</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES PALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOFIBRA 160 MG TABLETS GATE</medicinalproduct>
        <drugdosagetext>ONE TABLET DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100306</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138552-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.9154</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>1800MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABAPENTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138553-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011007320</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>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XIGRIS</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101120</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138554-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PK-ELI_LILLY_AND_COMPANY-PK201005001772</companynumb>
    <primarysource>
      <reportercountry>PAKISTAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOPULMONARY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugbatchnumb>A664391E</drugbatchnumb>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>500 MG/M2, UNK</drugdosagetext>
        <drugindication>LUNG ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100429</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138555-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201009003156</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>73.424</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugdosagetext>2080 MG, EVERY 2 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100928</drugenddate>
        <drugtreatmentduration>49</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AXITINIB</medicinalproduct>
        <drugdosagetext>10 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100725</drugenddate>
        <drugtreatmentduration>160</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugdosagetext>90 MG, EVERY 2 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100811</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugdosagetext>6 MG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100813</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VAGIFEM</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100721</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100818</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTIQ</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100817</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138556-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201010007215</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.066</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100811</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138557-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101128</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAXTER-2010BH029099</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOODY PERITONEAL EFFLUENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138558-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-BAXTER-2010BH029123</companynumb>
    <primarysource>
      <reportercountry>INDIA</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>PERITONEAL TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138559-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2010155708</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>DEPO-CLINOVIR</medicinalproduct>
        <drugauthorizationnumb>020246</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138560-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-FR-WYE-G06734710</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM DIFFICILE COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAZOCILLINE</medicinalproduct>
        <drugauthorizationnumb>050684</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080322</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080404</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARGOCID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080402</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIENAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080328</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138561-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-PFIZER INC-2008001848</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONTANEOUS HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZARATOR</medicinalproduct>
        <drugbatchnumb>0350096P</drugbatchnumb>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138562-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160615</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>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138563-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-GENENTECH-310198</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>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1000 MG, Q21D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SJOGREN'S SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091209</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138564-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99.7913</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
        <drugdosagetext>ONE TABLET 1 TAB AT BEDTIME PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SONATA</medicinalproduct>
        <drugdosagetext>ONE CAPSULE 1 CAP AT BEDTIME PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101128</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138565-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>23.587</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP TERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNAMBULISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOCALIN XR</medicinalproduct>
        <drugdosagetext>5MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DISTURBANCE IN ATTENTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101127</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138566-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>72.5755</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HCL AND ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1 6HRS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101129</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HCL AND ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1 6HRS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101129</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138568-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2010-42086</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>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugbatchnumb>EP072P0102</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138569-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PH-BAXTER-2010BH029126</companynumb>
    <primarysource>
      <reportercountry>PHILIPPINES</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>10D043</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>09U071</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100619</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138570-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BRACCO-000996</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTRAST MEDIA REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIATEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVONORM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KANRENOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELECTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONGESCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLORIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IOPAMIRO</medicinalproduct>
        <drugauthorizationnumb>018735</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COMPUTERISED TOMOGRAM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101117</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138571-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC.-2010-RO-01542RO</companynumb>
    <primarysource>
      <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>PREDNISONE</medicinalproduct>
        <drugbatchnumb>NR</drugbatchnumb>
        <drugauthorizationnumb>080352</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138572-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101128</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BAXTER-2010BH029128</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM WITH DEXTROSE 4.25% AND CALCIUM 2.5MEQ/L</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM WITH DEXTROSE 4.25% AND CALCIUM 2.5MEQ/L</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138573-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>104.3273</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugbatchnumb>B1139B01</drugbatchnumb>
        <drugdosagetext>ONCE MONTHLY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101004</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138576-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.0396</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMPYRA</medicinalproduct>
        <drugbatchnumb>QA556V</drugbatchnumb>
        <drugdosagetext>10MG Q12 HOURS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101107</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138579-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugdosagetext>10MG 1 Q DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugdosagetext>30MG 1 Q DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138584-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-AMGEN-AUTCT2010001087</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</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>TENDON INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DENOSUMAB</medicinalproduct>
        <drugindication>BONE DENSITY DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080311</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUTHYROX</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOMEXOR</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138585-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101128</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BAXTER-2010BH029130</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138586-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-ABBOTT-10P-066-0682455-00</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEMPLAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020819</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPERPARATHYROIDISM SECONDARY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090112</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138587-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRACCO-000305</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>NEPHROGENIC SYSTEMIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROHANCE</medicinalproduct>
        <drugauthorizationnumb>020131</drugauthorizationnumb>
        <drugindication>ABSCESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060817</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROHANCE</medicinalproduct>
        <drugauthorizationnumb>020131</drugauthorizationnumb>
        <drugindication>NUCLEAR MAGNETIC RESONANCE IMAGING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROHANCE</medicinalproduct>
        <drugauthorizationnumb>020131</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROHANCE</medicinalproduct>
        <drugauthorizationnumb>020131</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNISCAN</medicinalproduct>
        <drugindication>ABSCESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060823</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNISCAN</medicinalproduct>
        <drugindication>NUCLEAR MAGNETIC RESONANCE IMAGING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNISCAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060513</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138588-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2010SE45241</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>47</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES SIMPLEX OPHTHALMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FINIBAX</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>FEBRILE NEUTROPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100826</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FINIBAX</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100903</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>FEBRILE NEUTROPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100903</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GASTER D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100906</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOXOPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100904</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIRSTCIN INTRAVENOUS 1GM.</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>FEBRILE NEUTROPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100825</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URALYT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100420</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIYA-BM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100420</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUQUINON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100420</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138589-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161819</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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138590-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2010163945</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>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROXYZINE HCL</medicinalproduct>
        <drugauthorizationnumb>011459</drugauthorizationnumb>
        <drugdosagetext>25 MG, 100 MG/2ML INJECTION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100918</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERCIAN</medicinalproduct>
        <drugdosagetext>12.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>AGITATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100921</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARDEGIC</medicinalproduct>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAHOR</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERMIXON</medicinalproduct>
        <drugdosagetext>160 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>1 DF, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMAREL</medicinalproduct>
        <drugdosagetext>1 DF, 1X/DAY</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR ^DIECKMANN^</medicinalproduct>
        <drugdosagetext>1 DF, 1X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138591-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161828</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>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</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>20070702</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138592-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-FR-WYE-G05703010</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>29</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugauthorizationnumb>020589</drugauthorizationnumb>
        <drugdosagetext>1 DOSE FORM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100212</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITROMAX</medicinalproduct>
        <drugdosagetext>600 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100212</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HELICIDINE</medicinalproduct>
        <drugdosagetext>15 ML, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100212</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138593-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2010164051</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMMUNICATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugauthorizationnumb>011459</drugauthorizationnumb>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AGGRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>6 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AGGRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugdosagetext>30 GTT, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AGGRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugdosagetext>75 MG, 25MG IN AM, 50 MG IN PM</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANDROCUR</medicinalproduct>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LARGACTIL</medicinalproduct>
        <drugdosagetext>200 MG, AT NIGHT IF NEEDED</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>AGITATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THERALENE</medicinalproduct>
        <drugdosagetext>40 GTT, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAFALGAN</medicinalproduct>
        <drugdosagetext>1 G, 3X/DAY, IF PAIN</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138594-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161825</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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</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>20071001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138595-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2010163842</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>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugauthorizationnumb>011459</drugauthorizationnumb>
        <drugdosagetext>24 TABLETS; TOTAL AMOUNT: 600 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPIPRAMOL</medicinalproduct>
        <drugdosagetext>50 TABLETS; TOTAL AMOUNT: 5000 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXEPIN HCL</medicinalproduct>
        <drugdosagetext>20 TABLETS; TOTAL AMOUNT: 100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL</medicinalproduct>
        <drugdosagetext>10 TABLETS; TOTAL AMOUNT: 1500 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138596-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161823</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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</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>20071001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138601-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101128</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAXTER-2010BH029252</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GANGRENE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138602-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033547</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>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138609-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOODY DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>200 MG EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20 MG EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101108</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138611-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LENALIDOMIDE</medicinalproduct>
        <drugdosagetext>25 MG EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100928</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138613-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-JNJFOC-20101200430</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138614-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010012495</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>102</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED *NO SUBJECT DRUG</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070627</drugenddate>
        <drugtreatmentduration>168</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED *PLACEBO</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070627</drugenddate>
        <drugtreatmentduration>168</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED *SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070627</drugenddate>
        <drugtreatmentduration>168</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUNITINIB MALATE</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070627</drugenddate>
        <drugtreatmentduration>168</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138615-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2009226352</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUNITINIB MALATE</medicinalproduct>
        <drugbatchnumb>E793</drugbatchnumb>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>25 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANCREATIC NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090519</drugenddate>
        <drugtreatmentduration>203</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLOR</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SANDOSTATIN</medicinalproduct>
        <drugdosagetext>30 MG, MONTHLY</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138616-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2010091837</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFLUX OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>*PREDNISONE</medicinalproduct>
        <drugdosagetext>5 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100812</drugenddate>
        <drugtreatmentduration>106</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED *NO SUBJECT DRUG</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>37.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100429</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED *PLACEBO</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>37.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100429</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUNITINIB MALATE</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>37.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100429</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100510</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugdosagetext>20 DF, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLECALCIFEROL</medicinalproduct>
        <drugdosagetext>500 IU, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DREISAFER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138617-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-PFIZER INC-2005159946</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUNITINIB MALATE</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051118</drugenddate>
        <drugtreatmentduration>106</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138618-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2010141138</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>600 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100817</drugenddate>
        <drugtreatmentduration>232</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>20 OR 40 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100817</drugenddate>
        <drugtreatmentduration>232</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138619-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>121</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IOPROMIDE</medicinalproduct>
        <drugdosagetext>120 ML ONCE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NECK MASS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138621-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>84.369</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RECTAL CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENTANERCEPT</medicinalproduct>
        <drugdosagetext>50MG WEEKLY SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138622-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99.7913</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>25 MG 2 TIMES DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101125</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138625-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.0604</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugdosagetext>1 2X DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101126</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138626-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2010SE56821</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIAS</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138627-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-BAXTER-2010BH029221</companynumb>
    <primarysource>
      <reportercountry>INDIA</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>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>1008074</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101028</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138628-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA-2010-0048427</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138629-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-BAXTER-2010BH029258</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUTRINEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138631-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0688089-00</companynumb>
    <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>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENOXYLATE HCL + ATROPINE SULFATE</medicinalproduct>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
        <drugindication>ASTHMA</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>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138632-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>118.5249</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LENALIDOMIDE</medicinalproduct>
        <drugdosagetext>25 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101129</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138634-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>90.7194</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>1 PILL 3 TIMES A DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100730</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HCL AND ACETAMINOPHEN</medicinalproduct>
        <drugbatchnumb>93/890</drugbatchnumb>
        <drugdosagetext>1 PILL -4-6 HOURS- 1 BEFORE BED PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101128</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138636-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM T WAVE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DESOGESTREL AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugdosagetext>1 TABLET QDAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENORRHAGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101126</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138638-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>93.441</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ PROPOXYPHENE HCL</medicinalproduct>
        <drugbatchnumb>?8551?</drugbatchnumb>
        <drugdosagetext>1 TABLET 4HRS PRN PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101129</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138640-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>
      <patientweight>56.6996</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>AS NEEDED PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138641-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-BAXTER-2010BH029262</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138642-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161549</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>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138643-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-PFIZER INC-2010161327</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTRANSAMINASAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TORVAST</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>40 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101028</drugenddate>
        <drugtreatmentduration>81</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGIOPLASTY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
        <drugtreatmentduration>86</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAUNAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138644-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>111.5849</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GRANULOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>125 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101130</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138645-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161688</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138646-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161722</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugauthorizationnumb>020334</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138647-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2010161556</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>92</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>103</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugauthorizationnumb>012151</drugauthorizationnumb>
        <drugdosagetext>25 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138648-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-1011USA01134</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>55</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD GLUCOSE ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD GLUCOSE ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100528</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100528</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100825</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138649-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0906USA03279</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADJUSTMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYSIPELAS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELANOCYTIC NAEVUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE STRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060804</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138650-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1011USA02749</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>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTIMICROBIAL (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND HCT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138651-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-TEVA-256515ISR</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>074656</drugauthorizationnumb>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138653-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>56.6996</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugindication>SURGERY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080506</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDROCORTISONE ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138654-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>84.369</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HCL AND ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1 TO 2 TABLETS EVERY 4 HOURS</drugdosagetext>
        <drugindication>TOOTHACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090320</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HCL AND ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1 TO 2 TABLETS EVERY 4 HOURS</drugdosagetext>
        <drugindication>TOOTHACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101129</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138658-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0707USA04229</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>79</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAESTHETIC COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATROPHIC VULVOVAGINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAUDA EQUINA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EDENTULOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMBOLISM VENOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPLANT SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABYRINTHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGAMENT RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR SPINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL HERPES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIODONTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST LAMINECTOMY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLOLISTHESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPOROMANDIBULAR JOINT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH RESORPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030726</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030725</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138659-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EBETAXEL 150MG/25ML EBEWE ARZNEIMITTEL GESMBH</medicinalproduct>
        <drugdosagetext>270MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138660-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1001USA01360</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>82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL LOSS OF WEIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APTYALISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK FIRST DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK LEFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIASTOLIC DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEARING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOOSE TOOTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MAJOR DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENT DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRIFASCICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DECOMPOSITION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010201</drugenddate>
        <drugtreatmentduration>672</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
        <drugtreatmentduration>1977</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138662-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0903USA04196</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>ABSCESS JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APICAL GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDIX DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATROPHIC VULVOVAGINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DENSITY INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL PLAQUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED TENDENCY TO BRUISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOBAR PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAIL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMOCHROMIC NORMOCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL TORUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEORADIONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURITIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTOCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKELETAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENIC GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUTURE RELATED COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPOROMANDIBULAR JOINT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DEPOSIT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060801</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060801</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OGEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138663-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-BAXTER-2010BH029265</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUTRINEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138664-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010007368</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>NPLATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138665-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0807AUS00164</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ETHYLSUCCINATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXOCOBALAMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138666-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-1011USA03498</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
        <drugauthorizationnumb>020180</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ALOPECIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROGAINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138667-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-1011USA01732</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138668-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-MERCK-1012POL00006</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>99</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLOGICAL EYELID DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL HYPOMOTILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugauthorizationnumb>017555</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100619</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugauthorizationnumb>017555</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100820</drugenddate>
        <drugtreatmentduration>62</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugauthorizationnumb>017555</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100903</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugauthorizationnumb>017555</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100905</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugauthorizationnumb>017555</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100907</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVASTIGMINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UBIDECARENONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA-3 MARINE TRIGLYCERIDES</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHOSPHATIDYL SERINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138669-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1010USA03360</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101015</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULERA TABLET</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138670-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-1006FRA00060</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>
      <patientweight>98</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugauthorizationnumb>022044</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100415</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138671-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-1011USA02135</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138672-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1011USA03747</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138673-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-MERCK-1011USA03406</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMEND</medicinalproduct>
        <drugauthorizationnumb>021549</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIEMETIC SUPPORTIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101026</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMEND</medicinalproduct>
        <drugauthorizationnumb>021549</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMEND</medicinalproduct>
        <drugauthorizationnumb>021549</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LIP AND/OR ORAL CAVITY CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101026</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIP AND/OR ORAL CAVITY CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101026</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEMETIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>LIP AND/OR ORAL CAVITY CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101026</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138675-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-MERCK-1011BRA00027</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>36</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
        <drugtreatmentduration>86</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugbatchnumb>3001910[CRM]</drugbatchnumb>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
        <drugtreatmentduration>86</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugbatchnumb>3001910[CRM]</drugbatchnumb>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHINITIS ALLERGIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138676-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033693</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>ANAEMIA HAEMOLYTIC AUTOIMMUNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100127</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138677-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TENDON PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugindication>INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138678-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13676BP</companynumb>
    <primarysource>
      <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>20101203</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138679-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13292BP</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM BROMIDE</medicinalproduct>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>5 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAT'S CLAW</medicinalproduct>
        <drugdosagetext>500 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138680-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC.-2010-RO-01575RO</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NASAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugbatchnumb>060970A</drugbatchnumb>
        <drugauthorizationnumb>076504</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138681-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033690</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 ARTERIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCLERODERMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101107</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138682-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13678BP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <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>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138683-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13193BP</companynumb>
    <primarysource>
      <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>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC 75</medicinalproduct>
        <drugbatchnumb>A55144</drugbatchnumb>
        <drugauthorizationnumb>020520</drugauthorizationnumb>
        <drugdosagetext>75 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL ER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138684-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC.-2010-RO-01564RO</companynumb>
    <primarysource>
      <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>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CODEINE</medicinalproduct>
        <drugbatchnumb>NR</drugbatchnumb>
        <drugauthorizationnumb>022402</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138685-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033827</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>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101120</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138686-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NAPPMUNDI-GBR-2010-0007458</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE ACCIDENTAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE CR TABLET</medicinalproduct>
        <drugauthorizationnumb>087571</drugauthorizationnumb>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DULOXETINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORFLUOXETINE</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>LISINOPRIL</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>PANTOPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALSALATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138687-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-BAXTER-2010BH029282</companynumb>
    <primarysource>
      <reportercountry>INDIA</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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138688-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-AVENTIS-2010SA073047</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>49</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DROWNING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA UNSTABLE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA UNSTABLE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060822</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIART</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020822</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOGLIBOSE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080408</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MITIGLINIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080408</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLARAMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090717</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT CC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM POLYSTYRENE SULFONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAC-B</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090313</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLONEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080912</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANCREAZE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090313</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138690-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>61.2356</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugdosagetext>100MG TWICE DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANDIDIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101129</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138692-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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 PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIVASTIGMINE TARTRATE</medicinalproduct>
        <drugbatchnumb>JK13413A</drugbatchnumb>
        <drugdosagetext>TAKE 1 CAPSULE IN THE MORNING AND IN THE EVENING</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138693-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
        <drugdosagetext>2QHS  ^MANY YEARS^</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138694-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GILEAD-GB-CVT-100161</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIC RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANEXA</medicinalproduct>
        <drugauthorizationnumb>021526</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100310</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERSANTINE</medicinalproduct>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICORANDIL</medicinalproduct>
        <drugindication>ANGINA PECTORIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL                         /00802601/</medicinalproduct>
        <drugindication>ANGINA PECTORIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE                         /00032601/</medicinalproduct>
        <drugindication>LEFT VENTRICULAR FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL                         /00894001/</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOMIX /01475801/</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138695-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028878</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101115</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138696-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028899</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138697-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028903</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>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAILURE TO THRIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101127</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138698-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028909</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138699-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028912</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101126</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138700-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH029112</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>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138701-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-BAXTER-2010BH029115</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138702-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-BAXTER-2010BH029120</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138703-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAXTER-2010BH029154</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138704-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH029173</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>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138705-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH029174</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138706-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugdosagetext>50MG QD X 28D OFF 14D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROID CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100910</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138709-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>24.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGAMMAGLOBULINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB (ANTI-CD20) GENENTECH</medicinalproduct>
        <drugdosagetext>375 MG/M2 1 X 4 WK IV INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEUROBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB (ANTI-CD20) GENENTECH</medicinalproduct>
        <drugdosagetext>375 MG/M2 1 X 4 WK IV INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OPSOCLONUS MYOCLONUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTH</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNE GLOBULIN INTRAVENOUS (HUMAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MERCAPTOPURINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138711-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>40.8237</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CUBICIN</medicinalproduct>
        <drugdosagetext>240MG DAILY IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>OSTEOMYELITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100918</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138712-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66.6788</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LENALIDOMIDE</medicinalproduct>
        <drugdosagetext>50MG QD D1-28 PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101126</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZACITIDINE</medicinalproduct>
        <drugbatchnumb>91088A</drugbatchnumb>
        <drugdosagetext>25MG/M2 D1-5 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101126</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138714-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>36.2878</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATIONS, MIXED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugbatchnumb>7996663D</drugbatchnumb>
        <drugdosagetext>10MG QID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101130</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138715-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>2</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>A10A22/0703</drugbatchnumb>
        <drugdosagetext>10MG DAILY ORALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAPSONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138718-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugdosagetext>15MG DAILY 21D/28D ORALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AMYLOIDOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugdosagetext>15MG DAILY 21D/28D ORALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138719-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.2554</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugdosagetext>750 ONE A DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MASTOIDITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugdosagetext>750 ONE A DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138721-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NAPPMUNDI-GBR-2010-0007457</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>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE CR TABLET</medicinalproduct>
        <drugauthorizationnumb>087571</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPYRIDAMOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>50 MG, BID</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138722-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.246</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>2 GRAM DAILY IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101126</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138723-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</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>SPRYCEL</medicinalproduct>
        <drugdosagetext>100 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101124</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138725-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>60.3284</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PASIREOTIDE LAR</medicinalproduct>
        <drugdosagetext>20MG</drugdosagetext>
        <drugindication>MENINGIOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GUAIFENESIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138726-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>77.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugdosagetext>990 MG Q2 WKS. IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugdosagetext>990 MG Q2 WKS. IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>79 2 MG Q2 WKS. IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>79 2 MG Q2 WKS. IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUMEPIRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138728-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>23.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAZE PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STARING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>890 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>24 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugdosagetext>3.9 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>126 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugdosagetext>66 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>404 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THIOGUANINE</medicinalproduct>
        <drugdosagetext>500 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138729-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>91</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugdosagetext>150 MG BID</drugdosagetext>
        <drugindication>ARRHYTHMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101126</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALCIUM CARBONATE / VIT D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETIMIBE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASONE NASAL INHALER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEMANTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE SR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTAQ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138731-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHIRE-SPV1-2010-02088</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>32.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADDERALL XR 10</medicinalproduct>
        <drugauthorizationnumb>021303</drugauthorizationnumb>
        <drugdosagetext>15 MG, 1X/DAY:QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138733-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-BAXTER-2010BH028933</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138734-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-NAPPMUNDI-GBR-2010-0007440</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>022272</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138735-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2010161005</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138736-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2010159943</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SIALOADENITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN HCL</medicinalproduct>
        <drugauthorizationnumb>050441</drugauthorizationnumb>
        <drugdosagetext>1800 IU, DAILY</drugdosagetext>
        <drugindication>TOOTH EXTRACTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138737-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160959</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>BRADYPHRENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOVIAZ</medicinalproduct>
        <drugauthorizationnumb>022030</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY INCONTINENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HEART RATE IRREGULAR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138738-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010160914</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOCTURNAL DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AROMASIN</medicinalproduct>
        <drugauthorizationnumb>020753</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138739-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010157699</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>FIBERCON</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138740-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161292</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>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF INJURIOUS BEHAVIOUR</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>20080501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138741-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>31</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>B-LYMPHOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGAMMAGLOBULINAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB (ANTI-CD20) GENETECH</medicinalproduct>
        <drugdosagetext>375 MG/M2 1 X 4 WK IV INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ENCEPHALITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugdosagetext>20 MG/M2/DAY 4 DAYS/MO X2, THEN X1 IV, LATER PO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081219</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNE GLOBULIN INTRAVENOUS (HUMAN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138744-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>95.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUTROGENA ON THE SPOT TREATMENT</medicinalproduct>
        <drugdosagetext>SMALL AMOUNT APPLIED ON FINGER 1X PER DAY L 2 DAY APPLIED DIRECTLY TO SKIN</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101127</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUTROGENA ON THE SPOT TREATMENT</medicinalproduct>
        <drugdosagetext>SMALL AMOUNT APPLIED ON FINGER 1X PER DAY L 2 DAY APPLIED DIRECTLY TO SKIN</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101128</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138746-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>1556 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>2415 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>840 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101130</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138747-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGAMMAGLOBULINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB (ANTI-CD20) GENETECH</medicinalproduct>
        <drugdosagetext>375 MG/M2 1 X 4 WK IV INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MYOCLONUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020408</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB (ANTI-CD20) GENETECH</medicinalproduct>
        <drugdosagetext>375 MG/M2 1 X 4 WK IV INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEUROBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020408</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEPTRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNE GLOBULIN INTRAVENOUS (HUMAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MERCAPTOPURINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTH</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138750-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>40</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUNITINIB</medicinalproduct>
        <drugdosagetext>50MG ONCE DAILY</drugdosagetext>
        <drugindication>RENAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138751-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-GENENTECH-310202</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>B6030B01, B6133B01,B6121B01, B5032+</drugbatchnumb>
        <drugdosagetext>700 MG, Q3W</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100928</drugenddate>
        <drugtreatmentduration>120</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENDOXAN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1300 MG, UNK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100928</drugenddate>
        <drugtreatmentduration>120</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONCOVIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>2 MG, Q3W</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100928</drugenddate>
        <drugtreatmentduration>120</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRIBLASTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>90 MG, Q3W</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100928</drugenddate>
        <drugtreatmentduration>120</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100928</drugenddate>
        <drugtreatmentduration>120</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>300 MG, Q3W</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100928</drugenddate>
        <drugtreatmentduration>120</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138752-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-310365</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>CENTRAL NERVOUS SYSTEM LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>H2 ANTAGONISTS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOCORTICOID NOS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138753-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-AMGEN-NLDSP2010006934</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>NPLATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138754-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006772</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138755-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENZYME-FLUD-1000469</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN HERNIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMYELINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDROCEPHALUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020038</drugauthorizationnumb>
        <drugdosagetext>30 MG/M2, QDX4</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>750 MG/M2, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1.2 G/M2, QDX4</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138756-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011006198</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>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138757-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011006230</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>BLOOD AMYLASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138758-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ELI_LILLY_AND_COMPANY-CA201010005329</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>BLOOD GLUCOSE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIC UNCONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138759-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011006154</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>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION DURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>A751249A</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, MONTHLY (1/M)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugdosagetext>UNK, 3/W</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138760-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE200710004374</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYASTHENIA GRAVIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 1 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
        <drugtreatmentduration>66</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTAERYTHRITOL TETRANITRATE</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138761-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011001046</companynumb>
    <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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNDERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>A662723A</drugbatchnumb>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>10 U, OTHER</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>A662723A</drugbatchnumb>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>A731159A</drugbatchnumb>
        <drugdosagetext>10 U, OTHER</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>A731159A</drugbatchnumb>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>UNK, 2/D</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138762-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201009002693</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090501</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>A600581A</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </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>VASERETIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</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>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</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>ZOCOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138763-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011006387</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>1000 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugdosagetext>1.25 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>25 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>100 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENABLEX                            /01760402/</medicinalproduct>
        <drugdosagetext>15 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138764-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugdosagetext>400MG Q 4 WEEKS SUB-Q</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101015</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138765-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORINOSTAT</medicinalproduct>
        <drugdosagetext>300MG DAILY</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138766-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-10P-062-0686131-00</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>ARTHRODESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100816</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100927</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138767-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-10P-062-0687866-00</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INGUINAL HERNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138768-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-GILEAD-E2B_00000747</companynumb>
    <primarysource>
      <reportercountry>DENMARK</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>RIGHT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBRISENTAN</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALEORID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD POTASSIUM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAREVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIURETIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100606</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138769-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2010158430</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TREVILOR RETARD</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138770-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010159413</companynumb>
    <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>CORNEAL ABRASION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138771-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010159399</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>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138772-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010159161</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>ALCOHOL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF EMPLOYMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>020151</drugauthorizationnumb>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138773-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-PFIZER INC-2010158360</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD TITUBATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASTICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRISMUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>37.5 MG, 2X/DAY</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEPONEX ^NOVARTIS^</medicinalproduct>
        <drugdosagetext>25 MG, 1X/DAY</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEPONEX ^NOVARTIS^</medicinalproduct>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138774-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>
      <patientweight>89</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
        <drugdosagetext>5 MG AT BEDTIME PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100710</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138775-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugdosagetext>250 MG EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100705</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138776-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GILEAD-2010-0031617</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugauthorizationnumb>021356</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100430</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPSERA</medicinalproduct>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100215</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138777-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13590BP</companynumb>
    <primarysource>
      <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>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138778-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC.-2010-RO-01579RO</companynumb>
    <primarysource>
      <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>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugbatchnumb>NR</drugbatchnumb>
        <drugauthorizationnumb>076504</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>SINUS CONGESTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUGH MEDICINE</medicinalproduct>
        <drugindication>COUGH</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138779-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-12820BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020884</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TRANSIENT ISCHAEMIC ATTACK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugindication>HORMONE THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>TRANSIENT ISCHAEMIC ATTACK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugindication>BARRETT'S OESOPHAGUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138780-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13680BP</companynumb>
    <primarysource>
      <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>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138781-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-03373BP</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>9.06</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugauthorizationnumb>020933</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100320</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100320</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100320</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTRIMOXAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100320</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TONOFERON (COLLOIDAL IRON, FOLIC ACID, AND VITAMIN B12)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NUTRITIONAL SUPPORT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100320</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138782-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13677BP</companynumb>
    <primarysource>
      <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>055</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101203</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138783-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>
      <patientweight>93.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20 MG EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091231</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100616</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138784-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-AMGEN-ESPCT2010006930</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANITUMUMAB</medicinalproduct>
        <drugdosagetext>UNK UNK, Q2WK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>147 MG, Q2WK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>332 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>5-FU                               /00098801/</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138785-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU417887</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>250 A?G, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>250 A?G/KG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090729</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>200 A?G/KG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>250 A?G/KG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>UNK A?G/KG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101126</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138786-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU434884</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>9 A?G, UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091120</drugenddate>
        <drugtreatmentduration>143</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROID NOS</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138787-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>
      <patientweight>71.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugdosagetext>20 MG EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100530</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138788-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>A09022/05-A</drugbatchnumb>
        <drugdosagetext>10MG DAILY 21D/28D ORALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138789-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH018538</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>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100620</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138790-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033916</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>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugauthorizationnumb>021356</drugauthorizationnumb>
        <drugindication>HEPATITIS B</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138791-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-SANOFI-AVENTIS-2010SA069657</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>95.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN BASAL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090904</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090904</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138792-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.7194</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT SUBSTITUTION ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REACTION TO AZO-DYES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOTHROID</medicinalproduct>
        <drugdosagetext>ALL STRENGTHS EXCEPT 50 MCG DAILY TO TID PO (OVER MULTIPLE YEARS)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BASEDOW'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOTHROID</medicinalproduct>
        <drugdosagetext>ALL STRENGTHS EXCEPT 50 MCG DAILY TO TID PO (OVER MULTIPLE YEARS)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST PROCEDURAL HYPOTHYROIDISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138793-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>95.2554</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugdosagetext>1.2 MG SC QDAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138794-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028020</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>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100929</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138795-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028226</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IMPAIRED GASTRIC EMPTYING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138796-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJCH-2010026847</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>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYRTEC-D 12 HOUR</medicinalproduct>
        <drugbatchnumb>177438</drugbatchnumb>
        <drugauthorizationnumb>021150</drugauthorizationnumb>
        <drugdosagetext>TEXT:ONE TABLET ONCE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SEASONAL ALLERGY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONTELUKAST SODIUM</medicinalproduct>
        <drugdosagetext>TEXT:10MG 1X DAILY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138797-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011006615</companynumb>
    <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 HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138798-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ELI_LILLY_AND_COMPANY-IT201011002319</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIC COMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>8 D/F, DAILY (1/D)</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100819</drugenddate>
        <drugtreatmentduration>2057</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMICRON</medicinalproduct>
        <drugdosagetext>30 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100820</drugenddate>
        <drugtreatmentduration>2058</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138799-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-ELI_LILLY_AND_COMPANY-PL201012000778</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UNK, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101025</drugenddate>
        <drugtreatmentduration>134</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>500 D/F, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138800-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201011006986</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMATROPE</medicinalproduct>
        <drugauthorizationnumb>019640</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138801-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011007255</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYSTERECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMATROPE</medicinalproduct>
        <drugauthorizationnumb>019640</drugauthorizationnumb>
        <drugdosagetext>0.8 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGEN NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138802-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011006484</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>COMPLICATION OF PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>0.725 D/F, EVERY HOUR</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138803-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-ELI_LILLY_AND_COMPANY-TR201011007205</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART DISEASE CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugbatchnumb>A742183A</drugbatchnumb>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugbatchnumb>A730450A</drugbatchnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAMET</medicinalproduct>
        <drugdosagetext>UNK, 4/D</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
        <drugdosagetext>UNK, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100915</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138804-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-ELI_LILLY_AND_COMPANY-KR201011000118</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101106</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>UNK, 2/D</drugdosagetext>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138805-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011000447</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>120.18</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138806-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011007257</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>CORONARY ARTERY BYPASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEG AMPUTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19530101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>33 U, DAILY (1/D)</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138807-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011007250</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.84</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PEMPHIGOID</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugdosagetext>1 D/F, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138808-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RU-ELI_LILLY_AND_COMPANY-RU201011005518</companynumb>
    <primarysource>
      <reportercountry>RUSSIAN FEDERATION</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRA-UTERINE DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL CORD DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>8 U, 3/D</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugdosagetext>16 U, 2/D</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN                        /00249601/</medicinalproduct>
        <drugdosagetext>0.5 D/F, 3/D</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>BACTERIURIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138809-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011007251</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE GRAFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLASTIC SURGERY TO THE FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN GRAFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMATROPE</medicinalproduct>
        <drugbatchnumb>A669845D</drugbatchnumb>
        <drugauthorizationnumb>019640</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138810-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201012000276</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>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOMATROPIN</medicinalproduct>
        <drugauthorizationnumb>019640</drugauthorizationnumb>
        <drugdosagetext>0.2 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugdosagetext>100 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>500 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>150 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL</medicinalproduct>
        <drugdosagetext>40 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
        <drugdosagetext>5 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE HCL</medicinalproduct>
        <drugdosagetext>0.1 MG, 1 TABLET EVERY MORNING AND TWO TABLETS IN THE EVENING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLECALCIFEROL</medicinalproduct>
        <drugdosagetext>1000 U, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>1 D/F, AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugdosagetext>1 D/F, 4/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE CHONDROITIN</medicinalproduct>
        <drugdosagetext>1 D/F, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MSM</medicinalproduct>
        <drugdosagetext>1 D/F, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugdosagetext>1 D/F, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX /06442901/</medicinalproduct>
        <drugdosagetext>1 D/F, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugdosagetext>1 D/F, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10 MG, 1/2 TABLET THREE TIMES WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugdosagetext>50 MG, 2/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTEF</medicinalproduct>
        <drugdosagetext>20 MG, 1 TABLET EVERY MORNING AND HALF TABLET EVERY EVENING</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138811-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011000871</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.365</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENOSYNOVITIS STENOSANS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>A654928A</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101108</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>A751249A</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
        <drugdosagetext>10 D/F, 4/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IMPAIRED GASTRIC EMPTYING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>40 D/F, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>50 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugdosagetext>50 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
        <drugdosagetext>25 D/F, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138812-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201006002263</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>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>200 D/F, UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138813-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-ELI_LILLY_AND_COMPANY-TR201012000475</companynumb>
    <primarysource>
      <reportercountry>TURKEY</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>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101014</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138814-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RU-ELI_LILLY_AND_COMPANY-RU201011007101</companynumb>
    <primarysource>
      <reportercountry>RUSSIAN FEDERATION</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACTERIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBCLAVIAN ARTERY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>6 U, 3/D</drugdosagetext>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>8 U, 3/D</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugdosagetext>16 U, 2/D</drugdosagetext>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138815-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ELI_LILLY_AND_COMPANY-IT201011007106</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100927</drugenddate>
        <drugtreatmentduration>228</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE AND METFORMIN HCL</medicinalproduct>
        <drugdosagetext>3 D/F, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100927</drugenddate>
        <drugtreatmentduration>2241</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100927</drugenddate>
        <drugtreatmentduration>2241</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100927</drugenddate>
        <drugtreatmentduration>3006</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138816-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ELI_LILLY_AND_COMPANY-BR201009004002</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugbatchnumb>A688065</drugbatchnumb>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>30 IU, 2/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugdosagetext>UNK, EACH EVENING</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
        <drugdosagetext>25 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROTEIN URINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDA                         /00032601/</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROTEINURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138817-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011006630</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138818-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-ELI_LILLY_AND_COMPANY-ZA201012000171</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
      <qualification>1</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>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138819-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011006599</companynumb>
    <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>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>80 U, EACH MORNING</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19760101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>70 U, EACH EVENING</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19760101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>140 U, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19760101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138820-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ELI_LILLY_AND_COMPANY-BR201011007464</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 GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>A749735</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138821-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-BAXTER-2010BH029102</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138822-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2010SE56649</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>CORONARY ARTERIAL STENT INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL 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>7138823-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH029103</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138824-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ASTRAZENECA-2010SE56055</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
        <drugtreatmentduration>41</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138825-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ASTRAZENECA-2010SE54530</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM SACHETS</medicinalproduct>
        <drugauthorizationnumb>021957</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138826-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-PURDUE-GBR-2010-0007455</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUTRANS TRANSDERMAL PATCH</medicinalproduct>
        <drugauthorizationnumb>021306</drugauthorizationnumb>
        <drugdosagetext>10 MCG, Q1H</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SPINAL COLUMN STENOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUTRANS TRANSDERMAL PATCH</medicinalproduct>
        <drugauthorizationnumb>021306</drugauthorizationnumb>
        <drugdosagetext>5 MCG, Q1H</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138827-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ODYNOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGIC MOUTHWASH</medicinalproduct>
        <drugdosagetext>40 ML PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ODYNOPHAGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>40 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugdosagetext>200 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CANDIDIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABRAXANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100802</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG FILGRASTIM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugindication>ORAL CANDIDIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>1056 MG</drugdosagetext>
        <drugindication>ORAL CANDIDIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG FILGRASTIM</medicinalproduct>
        <drugdosagetext>006 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138828-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH005220</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>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PERIPHERAL REVASCULARISATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080417</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080417</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080416</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080418</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080418</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN ^A.L.^</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</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>BUPROPION</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>POLYETHYLENE GLYCOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEPHROCAPS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HYDROCHLORIDE</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>MIRTAZAPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDODRINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIPERACILLIN W/TAZOBACTAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138829-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-TEVA-258224ISR</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS TOXIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY TOXIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugauthorizationnumb>074067</drugauthorizationnumb>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138830-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-TEVA-252129ISR</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC LYMPHOCYTIC LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugauthorizationnumb>020622</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONTRACEPTIVES NOS</medicinalproduct>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138831-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-257882USA</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>COPAXONE</medicinalproduct>
        <drugauthorizationnumb>020622</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100527</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138832-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-258036USA</companynumb>
    <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>COPAXONE</medicinalproduct>
        <drugauthorizationnumb>020622</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080715</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138833-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006745</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>NPLATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100724</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138834-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-CEPHALON-2010006299</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>100</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE BONE MARROW APLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TREANDA</medicinalproduct>
        <drugauthorizationnumb>022249</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100910</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEBIVOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100921</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138835-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101200399</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>0RMKA63701</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138836-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101109117</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMPONI</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMPONI</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138837-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-JNJFOC-20100808529</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>INITIATED WK 54 OF INFLIXIMAB TREATMENT, DISCONTINUED DUE TO LACK OF EFFICACY/DRUG INEFFECTIVENESS</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138838-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-JNJFOC-20101200331</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138839-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-EISAI INC.-E3810-04274-SPO-IT</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF INJURIOUS BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARIET (RABEPRAZOLE)</medicinalproduct>
        <drugauthorizationnumb>020973</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENTACOL</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN</medicinalproduct>
        <drugdosagetext>875MG / 125 MG</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138840-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJCH-2010027434</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COOL MINT LISTERINE POCKETPAKS</medicinalproduct>
        <drugbatchnumb>733974</drugbatchnumb>
        <drugdosagetext>TEXT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138841-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-AMGEN-ITASP2010007328</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>250 A?G, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOCYTOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101117</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138842-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101128</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-NAPPMUNDI-GBR-2010-0007398</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUTRANS 20MG TRANSDERMAL PATCH</medicinalproduct>
        <drugauthorizationnumb>021306</drugauthorizationnumb>
        <drugdosagetext>20 MCG, Q1H</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugdosagetext>1 X TWO TO THREE DAILY PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>850 UNK, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ART                                /00761001/</medicinalproduct>
        <drugdosagetext>50 UNK, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>40 UNK, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLO                               /00972402/</medicinalproduct>
        <drugdosagetext>10 UNK, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICROPIRIN</medicinalproduct>
        <drugdosagetext>100 UNK, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELTROXIN</medicinalproduct>
        <drugdosagetext>100 UNK, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138843-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BAXTER-2010BH029034</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>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1X 1080 MG I.V. ON 12 OCT 2010</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER FEMALE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101012</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138844-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66.2252</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPROPION</medicinalproduct>
        <drugdosagetext>150MG BID ORALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080826</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138845-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-13844618</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>32</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IMMUNOGLOBULIN E INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CACHEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAFT DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIV INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR ICTERUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE COLOUR ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
        <drugdosagetext>CUMULATIVE DOSE:50383.33333</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugauthorizationnumb>020154</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANTIRETROVIRAL THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIRETROVIRAL THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIRETROVIRAL THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KIVEXA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANTIRETROVIRAL THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANTIRETROVIRAL THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CO-TRIMOXAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANTIRETROVIRAL THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NELFINAVIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANTIRETROVIRAL THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISENTRESS</medicinalproduct>
        <drugdosagetext>TABS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138846-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20101109126</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMPONI</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMPONI</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFLUENZA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOCONAZOLE</medicinalproduct>
        <drugindication>VULVOVAGINAL MYCOTIC INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CICLOPIROX OLAMINE</medicinalproduct>
        <drugadministrationroute>003</drugadministrationroute>
        <drugindication>VULVOVAGINAL MYCOTIC INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138847-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-JNJFOC-20101200525</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>TREATMENT INITIATED 3 YEARS AGO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAL DIABETES MEDICATION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138848-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101108545</companynumb>
    <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>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCENTRATED TYLENOL INFANT DROPS</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCENTRATED TYLENOL INFANT DROPS</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138849-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15379928</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>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPRYCEL</medicinalproduct>
        <drugauthorizationnumb>021986</drugauthorizationnumb>
        <drugdosagetext>INTERRUPTED AND RESTARTED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138850-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101128</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-BRISTOL-MYERS SQUIBB COMPANY-15386154</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>NO OF INF:1 STRENGTH:5MG/ML; RECENT DOSE:01NOV10</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>DAY 1 OF CYCLE RECENT DOSE:01NOV10</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>DAY 1 TO 15 TEMP DISCOTINUED:7NOV10</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101107</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138851-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15400112</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>89</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMAGNESAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugbatchnumb>09C00216B</drugbatchnumb>
        <drugdosagetext>18OCT-15NOV2010(28DAYS), 5TH INF  535MG: UNK-22NOV2010</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEAD AND NECK CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101115</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>MOST RECENT DOSE ON 08NOV10</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEAD AND NECK CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101108</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>MOST RECENT INF ON08NOV10</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEAD AND NECK CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101108</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>RASH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
        <drugdosagetext>1 DF = 12.5-25 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON HCL</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugdosagetext>BID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMEND</medicinalproduct>
        <drugdosagetext>DAY1:125 MG, DAY2:80 MG, DAY3:80 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARAFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>EVERY 6 HRS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138852-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-15405897</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugauthorizationnumb>020357</drugauthorizationnumb>
        <drugdosagetext>STRENGTH: 1000MG.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101018</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN  AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVIGARD PAC (COPACKAGED)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SURGAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULATARD</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138853-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-12823BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101113</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138854-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-12773BP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLON NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</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>20101111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101112</drugenddate>
      </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>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugindication>OVARIAN CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138855-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13700BP</companynumb>
    <primarysource>
      <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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101203</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138856-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-12836BP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TWYNSTA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022401</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138857-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-BRISTOL-MYERS SQUIBB COMPANY-15415581</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</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>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED: SAXAGLIPTIN</medicinalproduct>
        <drugauthorizationnumb>022350</drugauthorizationnumb>
        <drugdosagetext>LAST DOSE ON 24NOV10</drugdosagetext>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugauthorizationnumb>020357</drugauthorizationnumb>
        <drugdosagetext>CONTINUING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugdosagetext>CONTINUING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED: PLACEBO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>1 DF=}100MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101123</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138858-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101205</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13684BP</companynumb>
    <primarysource>
      <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>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>EMPHYSEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101205</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138859-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-12857BP</companynumb>
    <primarysource>
      <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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020884</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TRANSIENT ISCHAEMIC ATTACK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138860-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101204</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13681BP</companynumb>
    <primarysource>
      <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>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138861-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RO-BRISTOL-MYERS SQUIBB COMPANY-15418692</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>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>5MG/ML; DRUG INTERRUPTED ON 25NOV2010.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>ON DAY 1 OF CYCLE.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>FORM: TABLET, ON DAY 1-15.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138862-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-12860BP</companynumb>
    <primarysource>
      <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>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICTURITION URGENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <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>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugdosagetext>0.4 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138863-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101205</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13685BP</companynumb>
    <primarysource>
      <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>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138864-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-10P-062-0688198-00</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>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEMPLAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020819</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPERPARATHYROIDISM SECONDARY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECOSTRINOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEKRISTOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070720</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>L-THYROX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYPROTERONACETAT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070219</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENANTON</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>20080407</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRENANTONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080528</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DRESARIT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100716</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138865-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0688717-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.186</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <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>LYRICA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138866-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.2356</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NACYNTA</medicinalproduct>
        <drugdosagetext>100MG 1 - 2 3X/DAY RXED 10/29/10</drugdosagetext>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138867-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>50 MG ONCE A DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138868-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ASTRAZENECA-2010SE56171</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>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugauthorizationnumb>019627</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA PROCEDURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugauthorizationnumb>019627</drugauthorizationnumb>
        <drugdosagetext>650 MG/H (8 MG/KG/H)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugauthorizationnumb>019627</drugauthorizationnumb>
        <drugdosagetext>4 MG/KG/H ( 320 MG/H)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTIC THERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMIFENTANIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA PROCEDURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISATRACURIUM</medicinalproduct>
        <drugdosagetext>CONTINUOUS ADMINISTRATION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MUSCLE RELAXANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MANNITOL</medicinalproduct>
        <drugdosagetext>0.5 G/KG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138869-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ASTRAZENECA-2010SE56175</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugauthorizationnumb>019726</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRECOCIOUS PUBERTY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138870-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ASTRAZENECA-2010SE56240</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>96</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYE MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG DOSAGE FORM ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOLITHIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138871-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2010SE48260</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23950</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>42</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>021399</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100930</drugenddate>
        <drugtreatmentduration>57</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVAMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUROTEP</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGLAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EURODIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANVITAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100930</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138872-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>74.8435</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugbatchnumb>BXFGDEL</drugbatchnumb>
        <drugdosagetext>1 PILL DAILY</drugdosagetext>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101129</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138873-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85.7298</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATIONS, MIXED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138874-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHIRE-SPV1-2010-02098</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>ELAPRASE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>MUCOPOLYSACCHARIDOSIS II</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138875-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BIOGENIDEC-2010BI032501</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>IMMUNE RECONSTITUTION SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100827</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MODAFINIL</medicinalproduct>
        <drugindication>AFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXIN</medicinalproduct>
        <drugindication>AFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOL</medicinalproduct>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138876-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2010SE56211</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCUS TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORIATANE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IXEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORVASAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugdosagetext>400 MICROGRAM, TWO TIMES A DAY.</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARDEGIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARDYFERON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugdosagetext>AS REQUIRED.</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138877-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-BAXTER-2010BH028749</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT PACKAGING ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STARING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIDOCAINE HCL IN 5% DEXTROSE INJECTION IN PLASTIC CONTAINER</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138878-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJCH-2010026849</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>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugauthorizationnumb>019835</drugauthorizationnumb>
        <drugdosagetext>TEXT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SEASONAL ALLERGY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONTELUKAST SODIUM</medicinalproduct>
        <drugdosagetext>TEXT:10MG 1X DAILY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138879-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>70.3075</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>50 MG 2 X DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138880-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>133.8111</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>NIDC00781-1486</drugbatchnumb>
        <drugdosagetext>10 MG ONCE NIGHTLY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138881-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-GILEAD-E2B_00000900</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>2</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>TUBULOINTERSTITIAL NEPHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugauthorizationnumb>021752</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KIVEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEPTRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090921</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138882-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BAXTER-2010BH029125</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>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CANDIDIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CILEST</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOTRIMAZOLE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CANDIDIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138883-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15302755</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>
      <patientweight>83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>1DF=6AUC EVERY 21 DAYS LAST DOSE:5AUG10</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100805</drugenddate>
        <drugtreatmentduration>64</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED DISODIUM</medicinalproduct>
        <drugdosagetext>PEMETREXED DISODIUM VIAL MAINTENANCE THERAPY STARTED ON 26AUG10</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100603</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100519</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100519</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100519</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugdosagetext>FORM:TABS</drugdosagetext>
        <drugindication>VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100528</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugindication>VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100624</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100510</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100510</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138884-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687374A</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLI</medicinalproduct>
        <drugauthorizationnumb>021887</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVERWEIGHT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101021</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138885-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-15341696</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>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORENCIA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDOHAN</medicinalproduct>
        <drugdosagetext>11JAN6:29:5MG,30MAY7:12NOV7:4MG,13NOV7:30OCT8:3MG,31OCT8:9MAR9:2.5MG,10MAR9:21DEC9:2MG,22DEC9:1MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUCILLAMINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugdosagetext>1 DF= 400MG/58KG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIBENOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMITT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMELIAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASLON N</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138886-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugdosagetext>80MG BID SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>2.5MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101125</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138887-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7194</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>90053LX40</drugbatchnumb>
        <drugdosagetext>40MG BI-MONTHLY SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101115</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138888-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0618568-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNICEF</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050749</drugauthorizationnumb>
        <drugindication>EAR INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100105</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138889-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100223</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-09P-163-0615251-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>803</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EXPIRED DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNICEF</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050749</drugauthorizationnumb>
        <drugdosagetext>PHARMACIST DID NOT HAVE THE DOSE OR START DATES</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESCHERICHIA INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138890-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-10P-062-0687860-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEMPLAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020819</drugauthorizationnumb>
        <drugdosagetext>5 MCG PER WEEK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPERPARATHYROIDISM SECONDARY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100812</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AL-CL-HYDROXID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090716</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVELAMER</medicinalproduct>
        <drugdosagetext>800 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090617</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOETIN ALFA</medicinalproduct>
        <drugdosagetext>12000 IU PER WEEK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOETIN ALFA</medicinalproduct>
        <drugdosagetext>4000 IU PER WEEK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
        <drugdosagetext>1 MCG PER WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100812</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERRLECIT</medicinalproduct>
        <drugdosagetext>75 MG PER WEEK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100704</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMID</medicinalproduct>
        <drugdosagetext>30 DROPS TID, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugdosagetext>40 MG BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100507</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMETEROL/FLUTICASON</medicinalproduct>
        <drugdosagetext>25MCG/50MCG PUFF TWICE DAILY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090309</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DREISAVIT N</medicinalproduct>
        <drugdosagetext>1 TAB OD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENPROCOUMON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLECALCIFEROL</medicinalproduct>
        <drugdosagetext>20000 IT PER WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070418</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMIZOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101011</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138891-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0623694-00</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>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNICEF</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050749</drugauthorizationnumb>
        <drugindication>URINARY TRACT INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138892-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0664178-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>173.43</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100626</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
        <drugindication>RESPIRATORY DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138893-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091231</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0617730-00</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>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT STORAGE OF DRUG</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNICEF</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050749</drugauthorizationnumb>
        <drugdosagetext>125MG/5ML</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091228</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138894-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-09P-163-0613926-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNICEF</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050749</drugauthorizationnumb>
        <drugdosagetext>250 MG PER DAY.</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138895-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100309</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-09P-163-0613966-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>20.43</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNICEF</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050749</drugauthorizationnumb>
        <drugdosagetext>250/5ML 1 AND 1/2 TSP EVERY DAY</drugdosagetext>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugauthorizationnumb>050698</drugauthorizationnumb>
        <drugindication>SINUSITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138896-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-09P-163-0614407-00</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNICEF</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050749</drugauthorizationnumb>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138897-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100609</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0634067-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>9.08</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCREAMING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNICEF</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050749</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EAR INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100315</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138898-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0663138-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFDINIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050749</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138899-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0666042-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>27.24</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNICEF</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050749</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EAR INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100823</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138900-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0646015-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNICEF</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050749</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138901-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100708</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0635785-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>19.068</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNICEF</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050749</drugauthorizationnumb>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100324</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138902-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100421</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0628013-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>12.712</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFDINIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050749</drugauthorizationnumb>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100212</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138903-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0684453-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFDINIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050749</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138904-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101008</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0656343-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFDINIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050749</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OTITIS MEDIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138905-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100224</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0629267-00</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNICEF</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050749</drugauthorizationnumb>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALUPENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138906-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100607</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0650424-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EXPIRED DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNICEF</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050749</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138907-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100603</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0649519-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>13.62</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNICEF</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050749</drugauthorizationnumb>
        <drugdosagetext>3/4 TSP DAILY</drugdosagetext>
        <drugindication>OTITIS MEDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DELSYM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>OTITIS MEDIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138908-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-BAXTER-2010BH029220</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL PD-1</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138909-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>58.9676</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HCL AND ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1-2 DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ADNEXA UTERI PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HCL AND ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1-2 DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101130</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138910-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.4514</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138911-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.3993</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugdosagetext>SPRAY TO EACH NOSTRIL DAILY NASAL</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>RHINITIS ALLERGIC</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugdosagetext>SPRAY TO EACH NOSTRIL DAILY NASAL</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>SEASONAL ALLERGY</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138912-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0661465A</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
        <drugtreatmentduration>93</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138913-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0696643A</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>95.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA UNSTABLE</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>2MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050405</drugenddate>
        <drugtreatmentduration>58</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138914-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.1834</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>10 MG DAILY</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101031</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138915-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0770494A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138916-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0772898A</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>139.1</patientweight>
      <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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070502</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138917-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0774060A</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>113.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ANGIOPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030630</drugenddate>
        <drugtreatmentduration>967</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZOPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138918-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0774061A</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>
      <patientweight>92.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY BYPASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</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>20010220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138919-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0774240A</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>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138920-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0774399A</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070412</drugenddate>
        <drugtreatmentduration>775</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
        <drugtreatmentduration>325</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICRONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138921-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0774405A</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>145.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138922-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0775468A</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>60.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR GRAFT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BICARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138923-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0776444A</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>
      <patientweight>77.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070504</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138924-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0776650A</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>84.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138925-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0788260A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>135.5</patientweight>
      <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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050413</drugenddate>
        <drugtreatmentduration>97</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138926-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0788535A</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>
      <patientweight>90.9</patientweight>
      <patientsex>1</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 PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARAFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138927-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0788546A</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>100</patientweight>
      <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>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070924</drugenddate>
        <drugtreatmentduration>877</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138928-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0789216A</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>CEREBROVASCULAR ACCIDENT</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>20011231</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138929-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0791289A</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>
      <patientweight>90.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE CORONARY SYNDROME</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>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138930-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0793575A</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>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070824</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138931-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0793608A</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>130.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</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 VARIABLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138932-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0793830A</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>91.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138933-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0793836A</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>
      <patientweight>176.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138934-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0794163A</companynumb>
    <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>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138935-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0794470A</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>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050107</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138936-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0803361A</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>140.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC PACEMAKER INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>4MG BEFORE MEALS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138937-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0815569A</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>
      <patientweight>107.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138938-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0832351A</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>
      <patientweight>90.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE INJURIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</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>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDARYL</medicinalproduct>
        <drugauthorizationnumb>021700</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090428</drugenddate>
        <drugtreatmentduration>162</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138939-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0858778A</companynumb>
    <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>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138940-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0862418A</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081029</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138941-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0863804A</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138942-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0864598A</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>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138943-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0867106A</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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-CARDIAC CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138944-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0868761A</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI-CHOLESTEROL MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138945-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0869021A</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138946-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0869274A</companynumb>
    <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>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIC-ISCHAEMIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138947-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0873810A</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138948-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0875864A</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>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECONOMIC PROBLEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPLANTABLE DEFIBRILLATOR INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138949-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0875865A</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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</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>20051104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070219</drugenddate>
        <drugtreatmentduration>473</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138950-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0875866A</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>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY DISEASE</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060911</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138951-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0875868A</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>CARDIAC DISORDER</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138952-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0875870A</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070514</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138953-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0875872A</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>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138954-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0875873A</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>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERIAL STENT INSERTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080222</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138955-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0875879A</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>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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138956-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0876541A</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOTRIENT</medicinalproduct>
        <drugbatchnumb>0ZP5376</drugbatchnumb>
        <drugauthorizationnumb>022465</drugauthorizationnumb>
        <drugdosagetext>400MGD PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138957-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
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    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <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>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
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        <drugenddate>20080101</drugenddate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138958-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
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      <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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID OVERLOAD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART INJURY</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>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138959-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
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      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138960-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedate>20101206</receivedate>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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      <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>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050526</drugstartdate>
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        <drugtreatmentduration>778</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031217</drugstartdate>
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        <drugenddate>20050817</drugenddate>
        <drugtreatmentduration>610</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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    </patient>
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  <safetyreport>
    <safetyreportid>7138961-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
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      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHIAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COR PULMONALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRACHEAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRACHEAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
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        <drugenddate>20070401</drugenddate>
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  <safetyreport>
    <safetyreportid>7138962-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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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>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
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        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990501</drugstartdate>
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        <drugenddate>20071201</drugenddate>
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  <safetyreport>
    <safetyreportid>7138963-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
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    <receivedate>20101206</receivedate>
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    <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>
      <patientonsetage>45</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>20011201</drugstartdate>
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        <drugenddate>20081001</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDARYL</medicinalproduct>
        <drugauthorizationnumb>021700</drugauthorizationnumb>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
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  <safetyreport>
    <safetyreportid>7138964-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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      <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>68</patientonsetage>
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        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>CARDIAC PACEMAKER INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY DISEASE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
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        <drugstartdate>20040923</drugstartdate>
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        <drugenddate>20090101</drugenddate>
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  <safetyreport>
    <safetyreportid>7138965-X</safetyreportid>
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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>53</patientonsetage>
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        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
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        <drugcharacterization>1</drugcharacterization>
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  <safetyreport>
    <safetyreportid>7138966-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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      <reportercountry>UNITED STATES</reportercountry>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
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        <reactionmeddrapt>ARTERIAL OCCLUSIVE DISEASE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
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        <drugcharacterization>1</drugcharacterization>
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  <safetyreport>
    <safetyreportid>7138967-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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      <reportercountry>UNITED STATES</reportercountry>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
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        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>CARDIAC OPERATION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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  <safetyreport>
    <safetyreportid>7138968-5</safetyreportid>
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    <receiver></receiver>
    <patient>
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      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
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      <drug>
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    <receiver></receiver>
    <patient>
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      <reaction>
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      <reaction>
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    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0882205A</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <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>19990501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138985-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0882206A</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138986-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0882208A</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>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</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>19990501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138987-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0882749A</companynumb>
    <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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLLAPSE OF LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXPIRED DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN,0ZP7936</drugbatchnumb>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138988-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0882796A</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138989-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0882798A</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>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID OVERLOAD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE INJURIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138990-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0882800A</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 DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138991-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0882804A</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138992-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0882805A</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>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138993-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0882807A</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>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138994-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0882808A</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>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138995-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0882974A</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138996-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0883510A</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN SR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020358</drugauthorizationnumb>
        <drugdosagetext>150MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020089</drugauthorizationnumb>
        <drugdosagetext>400MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN CR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138997-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0884773A</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>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020983</drugauthorizationnumb>
        <drugdosagetext>2PUFF AT NIGHT</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138998-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0891841A</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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MORBILLIFORM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SELZENTRY</medicinalproduct>
        <drugauthorizationnumb>022128</drugauthorizationnumb>
        <drugdosagetext>150MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101109</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RALTEGRAVIR</medicinalproduct>
        <drugdosagetext>400MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101109</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATAZANAVIR</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101109</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101109</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7138999-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugdosagetext>40 MG -0.8ML- EVERY 2 WEEKS SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIPLE VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139000-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0892558A</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYCAMTIN</medicinalproduct>
        <drugauthorizationnumb>020671</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101109</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139001-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0893151A</companynumb>
    <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>ADVAIR</medicinalproduct>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061024</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139002-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0896743A</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>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL INDUCTION OF COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUTURE RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugauthorizationnumb>020007</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050630</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139003-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0896960A</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>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCUMORAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100831</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIVELLE</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139004-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0896977A</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>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEBULIZER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRONCHODILATOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139005-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0896979A</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>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-CARDIAC CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRAUMATIC LUNG INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugbatchnumb>0ZP9431</drugbatchnumb>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>EMPHYSEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUONEB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVENTIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXCEDRIN (MIGRAINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED YEAST RICE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALAVERT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139006-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897220A</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>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORIATANE</medicinalproduct>
        <drugauthorizationnumb>019821</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139007-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897510A</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>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROMACTA</medicinalproduct>
        <drugauthorizationnumb>022291</drugauthorizationnumb>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139008-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897526A</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>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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139009-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897562A</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139010-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897563A</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>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</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 TWICE PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100518</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051213</drugenddate>
        <drugtreatmentduration>118</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139011-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897564A</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>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139012-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897565A</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>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139013-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897566A</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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139014-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897567A</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139015-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897568A</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>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061213</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139016-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897569A</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080327</drugenddate>
        <drugtreatmentduration>789</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139017-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897570A</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>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139018-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897576A</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139019-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897577A</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070402</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139020-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
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    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897578A</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>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001211</drugstartdate>
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        <drugenddate>20060803</drugenddate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139021-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedate>20101206</receivedate>
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    <fulfillexpeditecriteria>1</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>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
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        <drugenddate>20000101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139022-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897580A</companynumb>
    <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>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139023-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897590A</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 INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugauthorizationnumb>018644</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVIGIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139024-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897591A</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>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELPHALAN HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>014691</drugauthorizationnumb>
        <drugdosagetext>200MGM2 SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100505</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139025-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897592A</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>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139026-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897653A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020121</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTOLIN HFA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020983</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139027-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897680A</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>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139028-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897681A</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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY BYPASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139029-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897686A</companynumb>
    <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>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139030-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897687A</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>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139031-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897688A</companynumb>
    <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>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139032-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897689A</companynumb>
    <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>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139033-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897690A</companynumb>
    <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>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139034-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897692A</companynumb>
    <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>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139035-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897693A</companynumb>
    <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>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139036-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897694A</companynumb>
    <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>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139037-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897696A</companynumb>
    <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>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139038-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897697A</companynumb>
    <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>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139039-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <seriousnessdeath>1</seriousnessdeath>
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    <companynumb>A0897698A</companynumb>
    <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>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139040-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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      <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>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139041-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897700A</companynumb>
    <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>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139042-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897709A</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
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        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139043-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
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    <companynumb>A0897716A</companynumb>
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      <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070103</drugenddate>
        <drugtreatmentduration>918</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139044-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
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      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139045-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897722A</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>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070710</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139046-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897724A</companynumb>
    <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>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139047-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
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    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897725A</companynumb>
    <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>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139048-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897726A</companynumb>
    <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>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139049-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897728A</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
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        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139050-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
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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>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
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  <safetyreport>
    <safetyreportid>7139051-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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      <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>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugstartdate>20020801</drugstartdate>
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  <safetyreport>
    <safetyreportid>7139052-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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      <reportercountry>UNITED STATES</reportercountry>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
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        <reactionmeddrapt>CARDIAC OPERATION</reactionmeddrapt>
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        <drugcharacterization>1</drugcharacterization>
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        <drugdosagetext>4MG PER DAY</drugdosagetext>
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        <drugstartdate>20060501</drugstartdate>
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  <safetyreport>
    <safetyreportid>7139053-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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      <reportercountry>UNITED STATES</reportercountry>
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    <receiver></receiver>
    <patient>
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        <drugcharacterization>1</drugcharacterization>
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        <drugstartdate>20040101</drugstartdate>
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  <safetyreport>
    <safetyreportid>7139054-0</safetyreportid>
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      <reportercountry>UNITED STATES</reportercountry>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>CARDIAC PACEMAKER INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART INJURY</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugstartdate>20040514</drugstartdate>
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    <safetyreportid>7139069-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897777A</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>CEREBROVASCULAR ACCIDENT</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>20050502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139070-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897778A</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 FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070514</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139071-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897779A</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>
      <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>20050120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050723</drugenddate>
        <drugtreatmentduration>185</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139072-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897780A</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>VOTRIENT</medicinalproduct>
        <drugauthorizationnumb>022465</drugauthorizationnumb>
        <drugdosagetext>800MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139073-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897781A</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>HEART INJURY</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139074-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897783A</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>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139075-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897801A</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>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139076-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897802A</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139077-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0470577A</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADENOCARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139078-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0658896A</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>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EROSION</reactionmeddrapt>
      </reaction>
      <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>20090819</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>2400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090819</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXEMESTANE</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100127</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CYSTITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090915</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAC B</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100224</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139079-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0672291A</companynumb>
    <primarysource>
      <reportercountry>GREECE</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>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELPHALAN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>014691</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100703</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100714</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>160MG PER DAY</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100703</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100714</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALACICLOVIR</medicinalproduct>
        <drugdosagetext>500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100714</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100714</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100722</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139080-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0672430A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAB</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugdosagetext>2000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100826</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUPRAC</medicinalproduct>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEO-DUR</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIGMART</medicinalproduct>
        <drugdosagetext>15MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
        <drugdosagetext>1500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOLVON</medicinalproduct>
        <drugdosagetext>12MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139081-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0675724A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSEUDOMEMBRANOUS COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <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>20091007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100614</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>2400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091013</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYDOXAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091013</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139082-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0677038A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMYELINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOTOR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1.4286MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APRANAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>550MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INEXIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IXPRIM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPECIAFOLDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1TAB WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>.25MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139083-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0679699A</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>TYKERB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139084-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.7194</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>60MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSTHYMIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139085-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0679853B</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugdosagetext>1500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100331</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>75MGM2 EVERY 3 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091009</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASTUZUMAB</medicinalproduct>
        <drugdosagetext>2MGK WEEKLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091009</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRASTUZUMAB</medicinalproduct>
        <drugdosagetext>372MG EVERY 3 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100827</drugenddate>
        <drugtreatmentduration>106</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139086-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0683408A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>36.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugauthorizationnumb>020207</drugauthorizationnumb>
        <drugdosagetext>70MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ALLOGENIC BONE MARROW TRANSPLANTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071105</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYMPHOGLOBULINE</medicinalproduct>
        <drugdosagetext>10MGM2 PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ALLOGENIC BONE MARROW TRANSPLANTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071105</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARA</medicinalproduct>
        <drugdosagetext>30MGM2 PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ALLOGENIC BONE MARROW TRANSPLANTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071105</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071115</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071116</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEU-UP</medicinalproduct>
        <drugdosagetext>250MCG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071212</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugdosagetext>.4MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>6MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071110</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugdosagetext>1000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071108</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071129</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071108</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071103</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHINESE MEDICINE</medicinalproduct>
        <drugdosagetext>7.5G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071107</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAKTAR</medicinalproduct>
        <drugdosagetext>2IUAX PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071125</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYALEIN</medicinalproduct>
        <drugdosagetext>10ML PER DAY</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071102</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZUNOL</medicinalproduct>
        <drugdosagetext>20G PER DAY</drugdosagetext>
        <drugadministrationroute>003</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071127</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTAMIN</medicinalproduct>
        <drugdosagetext>30G PER DAY</drugdosagetext>
        <drugadministrationroute>003</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071105</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTACIN</medicinalproduct>
        <drugdosagetext>10G PER DAY</drugdosagetext>
        <drugadministrationroute>003</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071105</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OFLOXACIN</medicinalproduct>
        <drugadministrationroute>031</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071106</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALONAL</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071124</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUMETHOLON</medicinalproduct>
        <drugadministrationroute>031</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071106</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HACHIAZULE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071107</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugdosagetext>10ML PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071107</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DISTILLED WATER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071107</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICOTINE POLACRILEX</medicinalproduct>
        <drugdosagetext>3IUAX PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071115</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMCINOLONE</medicinalproduct>
        <drugadministrationroute>003</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071126</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASTOMIN</medicinalproduct>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071202</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECOLICIN</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071126</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLITA-T3</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTERONON-R</medicinalproduct>
        <drugdosagetext>3G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071213</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARZULENE-S</medicinalproduct>
        <drugdosagetext>2.1G PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071213</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugdosagetext>1IUAX PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071213</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEISHOKU</medicinalproduct>
        <drugdosagetext>100ML PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071126</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
        <drugdosagetext>3MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071110</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLITA-T</medicinalproduct>
        <drugdosagetext>3000ML PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071126</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEYLON</medicinalproduct>
        <drugdosagetext>120ML PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071105</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugdosagetext>3ML PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071107</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTCILLIN</medicinalproduct>
        <drugdosagetext>3G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071111</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKACIN SULFATE</medicinalproduct>
        <drugdosagetext>160MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071115</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-CORTEF</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071107</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRODIF</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071111</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071126</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugdosagetext>72MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071115</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTEAMIN</medicinalproduct>
        <drugdosagetext>100ML PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071126</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WATER</medicinalproduct>
        <drugdosagetext>500ML PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071105</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
        <drugdosagetext>1000ML PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071126</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>10ML PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071107</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELEMENMIC</medicinalproduct>
        <drugdosagetext>2ML PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071126</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugdosagetext>1IUAX PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071126</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugdosagetext>.4MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071126</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAMMAGARD</medicinalproduct>
        <drugdosagetext>100ML SEVEN TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071120</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>80ML PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071112</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071107</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HAPTOGLOBIN</medicinalproduct>
        <drugdosagetext>1IUAX PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071107</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAGMIN</medicinalproduct>
        <drugdosagetext>3ML PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071126</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
        <drugdosagetext>14ML PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071126</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UROKINASE</medicinalproduct>
        <drugdosagetext>1IUAX PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071108</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBENIN</medicinalproduct>
        <drugdosagetext>1.5G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071116</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUNGUARD</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071126</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
        <drugdosagetext>500MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071126</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAGAMET</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071125</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HABEKACIN</medicinalproduct>
        <drugdosagetext>75MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071125</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUART</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071122</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE HCL</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071125</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUMIN (HUMAN)</medicinalproduct>
        <drugdosagetext>20ML PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071123</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071123</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARGOCID</medicinalproduct>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071126</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTROSYN</medicinalproduct>
        <drugdosagetext>.25MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071126</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASTET</medicinalproduct>
        <drugdosagetext>35MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071201</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSE</medicinalproduct>
        <drugdosagetext>100ML PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071201</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139087-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0683409A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugauthorizationnumb>020207</drugauthorizationnumb>
        <drugdosagetext>70MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ALLOGENIC BONE MARROW TRANSPLANTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091019</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE PHOSPHATE</medicinalproduct>
        <drugdosagetext>30MGM2 PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ALLOGENIC BONE MARROW TRANSPLANTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091019</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugdosagetext>.4MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091105</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugdosagetext>.3MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100209</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091022</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>17MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091024</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>17MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091027</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>17MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugdosagetext>900MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugdosagetext>1500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULCERLMIN</medicinalproduct>
        <drugdosagetext>20ML PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GOODMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091114</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALONAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>20ML PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBISOME</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAKTAR</medicinalproduct>
        <drugdosagetext>2IUAX PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091206</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPEMIN</medicinalproduct>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100103</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZUNOL</medicinalproduct>
        <drugdosagetext>40G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIRUDOID</medicinalproduct>
        <drugdosagetext>25G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEPAMIT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091213</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLITA-T NO.3</medicinalproduct>
        <drugdosagetext>2500ML PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091225</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugdosagetext>3ML PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugdosagetext>.3MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091223</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
        <drugdosagetext>2100MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTHROBIN P</medicinalproduct>
        <drugdosagetext>1.5IU3 PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091230</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHYSIO 35</medicinalproduct>
        <drugdosagetext>2500ML PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091227</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTEAMIN</medicinalproduct>
        <drugdosagetext>200ML PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091227</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELECTROLYTE FLUID</medicinalproduct>
        <drugdosagetext>2ML PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091227</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAGMIN</medicinalproduct>
        <drugdosagetext>9ML PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOLAMIN</medicinalproduct>
        <drugdosagetext>1IUAX PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091227</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>80ML PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091227</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091229</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMAN IMMUNE GLOBULIN</medicinalproduct>
        <drugdosagetext>5G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091214</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>5G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091214</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCLYTE-MG</medicinalproduct>
        <drugdosagetext>10ML PER DAY</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugdosagetext>.3MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKACIN SULFATE</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRAN</medicinalproduct>
        <drugdosagetext>1IUAX PER DAY</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE SULFATE</medicinalproduct>
        <drugdosagetext>.5MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091214</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HCL</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091214</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARGOCID</medicinalproduct>
        <drugdosagetext>800MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091111</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAMIMUNE N 5%</medicinalproduct>
        <drugdosagetext>5G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXIPIME</medicinalproduct>
        <drugdosagetext>3G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUMIN (HUMAN)</medicinalproduct>
        <drugdosagetext>100ML PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091228</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLITA-T</medicinalproduct>
        <drugdosagetext>500ML PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091205</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPARA K</medicinalproduct>
        <drugdosagetext>30ML PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLITA-T</medicinalproduct>
        <drugdosagetext>500ML PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091201</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugdosagetext>60ML PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091231</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUMIN (HUMAN)</medicinalproduct>
        <drugdosagetext>500ML PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091203</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEYLON</medicinalproduct>
        <drugdosagetext>100ML PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091203</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICOL</medicinalproduct>
        <drugdosagetext>20ML PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091223</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAMBAX</medicinalproduct>
        <drugdosagetext>1IUAX PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091221</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139088-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0683412A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>41.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC VEIN OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugauthorizationnumb>020207</drugauthorizationnumb>
        <drugdosagetext>68MGM2 PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ALLOGENIC BONE MARROW TRANSPLANTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091003</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100118</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091009</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091011</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091014</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOSYN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091012</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOSYN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091012</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
        <drugdosagetext>1500MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKACIN SULFATE</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091013</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARGOCID</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091026</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091120</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYMOMODULIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091025</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091015</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGLAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULCERLMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091022</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFZON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091015</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAKTAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091009</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091018</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HACHIAZULE</medicinalproduct>
        <drugadministrationroute>002</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091030</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091030</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PETROLATUM</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091011</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALONAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091020</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLROSANILINIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091022</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091022</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAVITAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091022</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYALEIN</medicinalproduct>
        <drugadministrationroute>031</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091016</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091017</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONILAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091020</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLOW-K</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091021</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091217</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091203</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091022</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GOODMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091025</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC OXIDE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091021</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIRUDOID</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091215</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEAVY MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TPN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091203</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTAMIN</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091124</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLARAMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091126</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EBASTINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091217</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RELENZA</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091210</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTIDE DISKUS</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RINDERON-V</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091209</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOIPAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTEAMIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091018</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLITA-T</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091006</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TPN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091018</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAGMIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091006</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091006</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIGH-CALORIE TRANSFUSION FLUID</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091006</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOLAMIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091018</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091014</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091030</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRODIF</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091011</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCEOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091007</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENOGLOBULIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091020</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENOGLOBULIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091117</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTHROBIN P</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091020</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTHROBIN P</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091116</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091018</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFATE DE MAGNESIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091018</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091116</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HAPTOGLOBIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091020</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-CORTEF</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091008</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUNGUARD</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091026</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091216</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUMIN (HUMAN)</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091015</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HANP</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091021</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUMIN (HUMAN)</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091017</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VEEN F</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091017</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLDACTONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091018</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLITA-T NO.3</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091026</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091026</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLITA-T</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091110</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091109</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RINGER'S SOLUTION</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091216</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091214</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091214</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOY</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091214</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139089-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0683631A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <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>20101008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101022</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TANATRIL</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYSLEE</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139090-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0685192A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>1IUAX PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
        <drugdosagetext>1IUAX PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>1IUAX PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugdosagetext>3IUAX PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGLAX</medicinalproduct>
        <drugdosagetext>2IUAX PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BASEN</medicinalproduct>
        <drugdosagetext>3IUAX PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STARSIS</medicinalproduct>
        <drugdosagetext>3IUAX PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139092-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0685864A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TROPONIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLTUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHONDROSULF</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139093-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0685893A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOPHREN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020007</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>8000MG CUMULATIVE DOSE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100823</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>800MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100823</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMEND</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>POLARAMINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AERIUS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMPERAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139094-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0686169A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALITIS HERPES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SIMPLE PARTIAL SEIZURES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100914</drugenddate>
        <drugtreatmentduration>124</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVIATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SIMPLE PARTIAL SEIZURES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDANTOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SIMPLE PARTIAL SEIZURES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SIMPLE PARTIAL SEIZURES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEXITIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SIMPLE PARTIAL SEIZURES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SIMPLE PARTIAL SEIZURES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAPP</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>SIMPLE PARTIAL SEIZURES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORIZON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SIMPLE PARTIAL SEIZURES</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139095-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0686536A</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>1</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>1</drugcharacterization>
        <medicinalproduct>REVOLADE</medicinalproduct>
        <drugauthorizationnumb>022291</drugauthorizationnumb>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101028</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICHEW D3</medicinalproduct>
        <drugdosagetext>2TAB PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139096-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0686717A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100716</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139097-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0686864A</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCAPNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIGHT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SERUM FERRITIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM DISCOLOURED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>POLFENON</medicinalproduct>
        <drugauthorizationnumb>019151</drugauthorizationnumb>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISOPROLOL</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
        <drugdosagetext>.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERINDOPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINPOCETINE</medicinalproduct>
        <drugdosagetext>5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETRALEX</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORMOTEROL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
        <drugdosagetext>400MCG TWICE PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTIC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139098-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0686878A</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIZIVIR</medicinalproduct>
        <drugauthorizationnumb>021205</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139099-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0686918A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DI-HYDAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101028</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>10DROP PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139100-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687129A</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugdosagetext>1500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAELYX</medicinalproduct>
        <drugdosagetext>75MG MONTHLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139101-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687169A</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBODART</medicinalproduct>
        <drugauthorizationnumb>022460</drugauthorizationnumb>
        <drugdosagetext>.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139102-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687210A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugauthorizationnumb>020207</drugauthorizationnumb>
        <drugdosagetext>350MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090630</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMERIN</medicinalproduct>
        <drugdosagetext>350MG PER DAY</drugdosagetext>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090626</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYLOCIDE</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090629</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUTROGIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090719</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-CORTEF</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090702</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIRSTCIN</medicinalproduct>
        <drugdosagetext>4G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAMIMUNE N 5%</medicinalproduct>
        <drugdosagetext>5G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090703</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXACIN</medicinalproduct>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090724</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
        <drugdosagetext>2G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090724</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUNGUARD</medicinalproduct>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090724</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugdosagetext>3G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOSITOL</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAKTAR</medicinalproduct>
        <drugdosagetext>1IUAX PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITRIZOLE</medicinalproduct>
        <drugdosagetext>20ML PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUVELA N</medicinalproduct>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugdosagetext>1500MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITOROL</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON HCL</medicinalproduct>
        <drugdosagetext>6MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100703</drugenddate>
        <drugtreatmentduration>53</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139103-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687250A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOPROSTENOL SODIUM</medicinalproduct>
        <drugauthorizationnumb>020444</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOBUTAMINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOPAMINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SILDENAFIL CITRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139104-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687388A</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <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>20071002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139105-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687391A</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN</medicinalproduct>
        <drugauthorizationnumb>050755</drugauthorizationnumb>
        <drugdosagetext>18ML PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101115</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139106-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687396A</companynumb>
    <primarysource>
      <reportercountry>VIET NAM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTUM</medicinalproduct>
        <drugbatchnumb>0017</drugbatchnumb>
        <drugauthorizationnumb>050634</drugauthorizationnumb>
        <drugdosagetext>1G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101127</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139107-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687517A</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPTODIN</medicinalproduct>
        <drugauthorizationnumb>021003</drugauthorizationnumb>
        <drugdosagetext>.1G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPSERA</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139108-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687533A</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORNEAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>022251</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139109-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687536A</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>DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AROPAX</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>.5TAB PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INJURY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139110-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687549A</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>EOSINOPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTIN</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRELLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOLIPAXIN</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139111-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687553A</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIP OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN</medicinalproduct>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugdosagetext>1G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TONSILLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101113</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139112-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687558A</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PROCTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYVERB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100415</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139113-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687566A</companynumb>
    <primarysource>
      <reportercountry>BULGARIA</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>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugauthorizationnumb>021345</drugauthorizationnumb>
        <drugdosagetext>7.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>THROMBOPHLEBITIS</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>BLOOD PRESSURE MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139114-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687570A</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN</medicinalproduct>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugdosagetext>1G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100913</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACHIDOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100913</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139115-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687571A</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FRUSEMIDE</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139116-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.0396</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EMBOLIC STROKE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugdosagetext>150 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEKANIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139117-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687598A</companynumb>
    <primarysource>
      <reportercountry>RUSSIAN FEDERATION</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENTEROCOLITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC DIATHESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYVERB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139118-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>D0069597A</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOTRIENT</medicinalproduct>
        <drugauthorizationnumb>022465</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139119-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>Z0004461B</companynumb>
    <primarysource>
      <reportercountry>PERU</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GW685698 + GW642444 INHALATION POWDER</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100406</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100406</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139120-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>Z0005226B</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPOTECAN</medicinalproduct>
        <drugauthorizationnumb>020671</drugauthorizationnumb>
        <drugdosagetext>10MG CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100819</drugstartdate>
      </drug>
      <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>20100803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugdosagetext>16MCG TWENTY FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>008</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>264 PER DAY</drugdosagetext>
        <drugadministrationroute>008</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>4MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>008</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>10MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugdosagetext>6MCG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>008</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100816</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPIVACAINE HCL</medicinalproduct>
        <drugdosagetext>4ML AS REQUIRED</drugdosagetext>
        <drugadministrationroute>008</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPIVACAINE HCL</medicinalproduct>
        <drugdosagetext>10MLH TWENTY FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>008</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDE</medicinalproduct>
        <drugdosagetext>20ML TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100809</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139121-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA81488</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>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100125</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139122-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010MX75704</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>93</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugdosagetext>1 PATCH (5CM2/4.6 MG) PER DAY</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139123-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-BAXTER-2010BH029222</companynumb>
    <primarysource>
      <reportercountry>POLAND</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>09I07G40</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>10F14G41</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>09J29G42</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>10G14G41</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139124-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10112659</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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AMYLOIDOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100417</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100711</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELPHALAN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AMYLOIDOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100715</drugenddate>
        <drugtreatmentduration>89</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AMYLOIDOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100715</drugenddate>
        <drugtreatmentduration>89</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139125-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010PE77153</companynumb>
    <primarysource>
      <reportercountry>PERU</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXFORGE</medicinalproduct>
        <drugauthorizationnumb>021990</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100903</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139126-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJCH-2010027450</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>104.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURNS THIRD DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRECISE EXTRA STRENGTH PAIN RELIEVING CREAM</medicinalproduct>
        <drugbatchnumb>0020LK</drugbatchnumb>
        <drugdosagetext>TEXT:ONCE</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>NECK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>TEXT:1X DAILY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139127-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2007DE04096</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>43</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMAUROSIS FUGAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100909</drugenddate>
        <drugtreatmentduration>2487</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139128-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010US11531</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>ABDOMINAL WALL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STI571/CGP57148B T35717+TAB</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>DOSE BLINDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100722</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139129-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10103003</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>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100131</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139130-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2009US01059</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE MARROW DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090409</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139131-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US59124</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>145</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugdosagetext>2.5 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100907</drugenddate>
        <drugtreatmentduration>177</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STARLIX</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugdosagetext>15 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139132-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CH82118</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>HEPATECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139133-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10080931</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>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100727</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>1/2</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100809</drugenddate>
        <drugtreatmentduration>89</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100727</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100805</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139134-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BE79513</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139135-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP80216</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>ONCE OR TWICE PER MONTH</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139136-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010NL57893</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO MUSCLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugbatchnumb>S0230</drugbatchnumb>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG/ 5 ML, 20MIN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugbatchnumb>S0230</drugbatchnumb>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG/ 5 ML</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100811</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugbatchnumb>S0230</drugbatchnumb>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG/ 5 ML</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugbatchnumb>S0235</drugbatchnumb>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG/ 5 ML</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANADOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINAPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOLON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE PUMP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139137-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US80989</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA PRIMARY ATYPICAL</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>ANTIBIOTICS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139138-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14407</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84.807</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGIOMYOLIPOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE TRIMMING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL PROSTHESIS PLACEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMANGIOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBARIC OXYGEN THERAPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LENTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASTOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL HERPES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR DENTAL CONDITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRIMARY SEQUESTRUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNORING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC EMBOLISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEELCHAIR USER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>90 MG, QMO</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN ^AVENTIS PHARMA^</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCOLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARAFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXEPIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIPEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>40 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>80 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMYLASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTEASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NARCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANCREATIC ENZYMES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139139-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP80215</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>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG PER ADMINISTRATION</drugdosagetext>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139140-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CH73072</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOPHLEBITIS SUPERFICIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, DAILY</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100215</drugenddate>
        <drugtreatmentduration>180</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AROMASIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100707</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100715</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEBIVOLOL HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOREM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MADOPAR</medicinalproduct>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139141-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US60953</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139142-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10101924</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>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090519</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEOSOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>1000 UNITS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100609</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101027</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139143-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010IT76329</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100204</drugenddate>
        <drugtreatmentduration>553</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139144-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US81714</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</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>20101108</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139145-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13628BP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LOWER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139146-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13711BP</companynumb>
    <primarysource>
      <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>SPIRIVA</medicinalproduct>
        <drugbatchnumb>003420A,0D1108</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>003420A,0D1108</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </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>PRILOSEC</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ROUTINE HEALTH MAINTENANCE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139147-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13699BP</companynumb>
    <primarysource>
      <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>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101203</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139148-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-12870BP</companynumb>
    <primarysource>
      <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 75</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020520</drugauthorizationnumb>
        <drugdosagetext>75 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139149-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101204</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13682BP</companynumb>
    <primarysource>
      <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>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139150-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13697BP</companynumb>
    <primarysource>
      <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>20101203</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139151-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60.54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>542 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>670 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>336 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139152-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2010SE56963</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>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY MASS</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>
        <drugindication>PARANOIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139153-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-ASTRAZENECA-2010SE56293</companynumb>
    <primarysource>
      <reportercountry>NORWAY</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>ATRIAL FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugauthorizationnumb>019962</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTAQ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FLUTTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100414</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139154-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ASTRAZENECA-2010SE56277</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>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100913</drugenddate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPO-MEDROL</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100624</drugenddate>
        <drugtreatmentduration>2766</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000728</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLEX</medicinalproduct>
        <drugdosagetext>THREE TIMES A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000802</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139155-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP81612</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR PROCEDURE COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TASIGNA</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100520</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139156-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US13089</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.819</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTINOMYCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE EROSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CENTRAL VENOUS CATHETERISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS NONINFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESSENTIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGIOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLANTAR FASCIITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEBORRHOEIC KERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLOARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEM CELL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPEUTICS NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEOCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139157-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2010US18414</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>81.633</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTERED AT INAPPROPRIATE SITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TESTICULAR PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugauthorizationnumb>022122</drugauthorizationnumb>
        <drugdosagetext>4 G, QID</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101129</drugenddate>
        <drugtreatmentduration>78</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139158-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010NL81809</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4MG/5ML</drugdosagetext>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139159-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2007US03686</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>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>500 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139160-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028633</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139161-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2010SE29318</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>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HETEROPHORIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIAS</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091101</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139162-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2010SE56298</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAL</medicinalproduct>
        <drugauthorizationnumb>019810</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139163-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2006US02673</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139164-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010SI81831</companynumb>
    <primarysource>
      <reportercountry>SLOVENIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONATE T29581+</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4MG/5ML/28DAYS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARIVARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZALDIAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139165-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US81712</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</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>20101124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101201</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139166-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010NL81992</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG/5 ML</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139167-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028658</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139168-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028507</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139169-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>21.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>480 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugdosagetext>5.2 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-L-ASPARAGINASE (PEASPARGASE, ONCOSPAR)</medicinalproduct>
        <drugdosagetext>4381 IU</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>140 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090921</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139170-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>72.5755</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
        <drugdosagetext>100/650 Q4-6HOURS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090417</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139171-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010KR81995</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139172-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHNY2007GB02695</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139173-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028827</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>PANCREATIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139174-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010IN81988</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>FEMARA</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139175-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-20785-10113076</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>ANIMAL BITE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>020785</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139176-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH029109</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>91</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101120</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139177-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJCH-2010027413</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>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugauthorizationnumb>020150</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>TEXT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>TEXT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139178-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA062168</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>DEVICE MALFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLOSTAR</medicinalproduct>
        <drugbatchnumb>0F283A</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>0F283A</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE:20 UNIT(S)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139179-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH029008</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139180-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10120264</companynumb>
    <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>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139181-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>124.7392</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HCL AND ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1-2 PILLS 4-6 HOURS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HCL AND ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1-2 PILLS 4-6 HOURS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139182-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.6996</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLUGGISHNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>2 MG NIGHTLY PO  ONCE A NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139183-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT LABEL ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugbatchnumb>210900</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139184-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10120288</companynumb>
    <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>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD TRANSFUSION</medicinalproduct>
        <drugdosagetext>2 PINTS A DAY FOR 3 DAYS</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRATION</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139185-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA066881</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEVICE MALFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLOSTAR</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS SOLOSTAR</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139186-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GILEAD-2010-0033980</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRENATAL SCREENING TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugauthorizationnumb>021752</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139187-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH029148</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139188-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10120224</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>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELOFIBROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugdosagetext>5MG ALTERNATING WITH 10MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELOFIBROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugdosagetext>60,000 UNITS</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091023</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS</medicinalproduct>
        <drugdosagetext>2 UNITS</drugdosagetext>
        <drugadministrationroute>051</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091023</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>060</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INTERFERON ALFA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WHOLE BLOOD</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139189-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.3075</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT SUBSTITUTION ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>POTASSIUM CITRATE</medicinalproduct>
        <drugdosagetext>10MEQ 2XDAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEPHROLITHIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139190-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10120249</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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139191-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-BAXTER-2010BH029247</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUTRINEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139192-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-BAXTER-2010BH029251</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139193-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH029151</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139194-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BAXTER-2010BH029152</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM WITH DEXTROSE 4.25% AND CALCIUM 2.5MEQ/L</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139195-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAXTER-2010BH029274</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</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139196-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTERED IN WRONG DEVICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN U-500</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN SYRINGE U-100 VARIOIUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139197-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010007283</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100629</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139198-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BAXTER-2010BH029317</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM WITH DEXTROSE 4.25% AND CALCIUM 2.5MEQ/L</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139199-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-BAXTER-2010BH029219</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101107</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139200-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ABBOTT-10P-013-0672334-00</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC STROKE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANIDIP</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>SERTRALINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</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>7139201-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-BAXTER-2010BH029223</companynumb>
    <primarysource>
      <reportercountry>INDIA</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>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>1009054</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139202-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PURDUE-USA-2010-0056293</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 DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</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>20101120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101121</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021745</drugauthorizationnumb>
        <drugdosagetext>200 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101122</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139203-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>27.2158</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MADAROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugdosagetext>1 TIME A DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139204-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>
      <patientweight>117.9352</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>VANCOMYCIN ONE TIME IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139205-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-SANOFI-AVENTIS-2010SA070716</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEVICE MALFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLOSTAR</medicinalproduct>
        <drugbatchnumb>0F258A</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS SOLOSTAR</medicinalproduct>
        <drugbatchnumb>0F258A</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139206-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100917</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJCH-2010015406</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DIET</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
        <drugauthorizationnumb>022155</drugauthorizationnumb>
        <drugdosagetext>TEXT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139207-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010007159</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>3 A?G/KG, UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101010</drugenddate>
        <drugtreatmentduration>94</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139208-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006807</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM</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>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139209-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.6996</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
        <drugdosagetext>DON'T REMEMBER CVS HAS INFO</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100919</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139210-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XIFAXAN</medicinalproduct>
        <drugdosagetext>DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC ENCEPHALOPATHY PROPHYLAXIS</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUESTRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMCINOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODIOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139211-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>105.2345</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugbatchnumb>GG957</drugbatchnumb>
        <drugdosagetext>4 MG 1-2 PER DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE SULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139212-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>91</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ODYNOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>001956</drugbatchnumb>
        <drugdosagetext>150 MG TWICE DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139213-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-SANOFI-AVENTIS-2010SA070805</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>170</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WRONG DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLOSTAR</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APIDRA SOLOSTAR</medicinalproduct>
        <drugauthorizationnumb>021629</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLOSTAR</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS SOLOSTAR</medicinalproduct>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETIC NEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19810101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139214-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-705278</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BETA-N-ACETYL-D-GLUCOSAMINIDASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HISTIOCYTOSIS HAEMATOPHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELLS URINE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugdosagetext>DISCONTINUED</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100823</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>DOSE FORM: PERORAL AGENT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100906</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>DOSE FORM: PERORAL AGENT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugdosagetext>DOSE FORM: PERORAL AGENT, DOSAGE IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMOCYSTIS JIROVECI PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAIXAN</medicinalproduct>
        <drugdosagetext>DOSE FORM: PERORAL AGENT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERRIC PYROPHOSPHATE</medicinalproduct>
        <drugdosagetext>DRUG: INCREMIN(FERRIC PYROPHOSPHATE,SOLUBLE)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139215-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-443598</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MAJOR DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIRECTAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIOLENCE-RELATED SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990825</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139216-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-635039</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 CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>15 MG/KG, UNK, LAST DOSE PRIOR TO SAE: 01 MAY 2009</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090427</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPOTECAN</medicinalproduct>
        <drugdosagetext>2.3 MG/M2, UNK, LAST DOSE PRIOR TO SAE: 01 MAY 2009</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUPIROCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139217-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101114</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA071030</companynumb>
    <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 MALFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>0F180A</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>0F180A</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139218-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201009006560</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A719441C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A719441C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139219-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201010004910</companynumb>
    <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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A713108C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLETAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NABUMETONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugdosagetext>7.5 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139220-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011005935</companynumb>
    <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>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139221-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201010005578</companynumb>
    <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>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOULDER ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A723779D</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100926</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugdosagetext>10 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugdosagetext>1000 MG, EACH EVENING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, QOD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>40 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>12 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>100 MG, 2/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D</medicinalproduct>
        <drugdosagetext>600 MG, 2/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM SILVER</medicinalproduct>
        <drugdosagetext>UNK, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STOOL SOFTENER</medicinalproduct>
        <drugdosagetext>UNK, DAILY (1/D)</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139222-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011006255</companynumb>
    <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>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139223-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011006455</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A736415C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139224-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201009003954</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.016</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>25 MG/ML 0.5 ML,UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUINOL</medicinalproduct>
        <drugdosagetext>200 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>1 MG 3 TAB, 4/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139225-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201010005998</companynumb>
    <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>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIZANIDINE</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>0.05 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139226-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201010005524</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139227-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011006959</companynumb>
    <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 DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139228-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201008002248</companynumb>
    <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>BLOOD TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A670122C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A723778C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>1 D/F, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>1 D/F, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugdosagetext>1 D/F, EACH EVENING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR HCT</medicinalproduct>
        <drugdosagetext>1 D/F, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugdosagetext>12.5 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
        <drugdosagetext>1 D/F, 2/D</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>5 MG, EACH EVENING</drugdosagetext>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>10 MG, EACH EVENING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>500 MG, AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM W/MAGNESIUM/ZINC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELATONIN</medicinalproduct>
        <drugdosagetext>5 MG, EACH EVENING</drugdosagetext>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139229-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201010003235</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 INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR HOLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139230-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011006606</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>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100219</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139231-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PK-ROCHE-644883</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2A</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090715</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090715</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELTROMBOPAG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOCYTOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090622</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELTROMBOPAG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090705</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELTROMBOPAG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090715</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED ELTROMBOPAG</medicinalproduct>
        <drugdosagetext>DOSE BLINDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOCYTOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090715</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139232-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-724616</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEILITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARAVIS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040422</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMNESTEEM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICYCLOMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030808</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020819</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139233-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13716BP</companynumb>
    <primarysource>
      <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>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139234-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13720BP</companynumb>
    <primarysource>
      <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>URINARY HESITATION</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>PLAVIX</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139235-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13717BP</companynumb>
    <primarysource>
      <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>SPIRIVA</medicinalproduct>
        <drugbatchnumb>003749A</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>EMPHYSEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>2.5 MG</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugdosagetext>2.5 MG</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139236-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.0396</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19880204</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139237-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>56.246</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HCL AND ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1 EVERY 6 HOURS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPINAL OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101201</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139238-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-ROCHE-733688</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRCERA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101031</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139239-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2010SE56835</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETA BLOCKER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139240-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-744712</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugdosagetext>600 MG IN MORNING AND 400 MG IN EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PF-00868554 (HCV POLYMERASE INHIBITOR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100820</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100820</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139241-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-KINGPHARMUSA00001-K201001367</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.116</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMBEDA</medicinalproduct>
        <drugauthorizationnumb>022321</drugauthorizationnumb>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101026</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugdosagetext>100/625 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139242-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA071057</companynumb>
    <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 BREAKAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE MALFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLOSTAR</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS SOLOSTAR</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139243-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-744944</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2A</medicinalproduct>
        <drugdosagetext>FREQUENCY: WEEKLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100218</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugdosagetext>DOSE: 3 PER MORNING AND EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED TMC435</medicinalproduct>
        <drugdosagetext>DOSE: BLINDED, FREQUENCY: QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100215</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139244-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-745015</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugbatchnumb>RJ0371</drugbatchnumb>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugdosagetext>EACH ON AN EMPTY STOMACH. OTHER INDICATION: ARTHROSIS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETSIM</medicinalproduct>
        <drugdosagetext>DOSE: 10+20 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTRODAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139245-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA072690</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEVICE MALFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>C783</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>C783</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139246-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-745171</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139247-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-745828</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>LAST DOSE PRIOR TO EVENT: 16 NOVEMBER 2010</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>LAST DOSE PRIOR TO EVENT: 16 NOVEMBER 2010</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>LAST DOSE PRIOR TO EVENT: 16 NOVEMBER 2010</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139248-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070817</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-746173</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139249-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-746186</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELPLAT</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFOLINATE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>5-FU</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>DRUG NAME; VOLTAREN(DICLOFENAC SODIUM).</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAL</medicinalproduct>
        <drugdosagetext>DOSE FORM: UNCERTAINTY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTAMIN</medicinalproduct>
        <drugdosagetext>DRUG NAME: MULTAMIN(MULTIPLE VITAMIN FOR TOTAL PARENTERAL NUTRITION)</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugdosagetext>DOSE FORM: UNCERTAINTY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100528</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugdosagetext>NOTE: DOSAGE DURING A DAY: 12MG/6MG/6MG/6MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100617</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139250-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA072691</companynumb>
    <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 MALFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>0F325A</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>0F325A</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139251-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-JPNCT2010007480</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DERMATITIS ACNEIFORM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBILIRUBINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMAGNESAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANITUMUMAB</medicinalproduct>
        <drugdosagetext>6 MG/KG, Q2WK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100907</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOCOID CREAM</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIRUDOID SOFT OINTMENT</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLONEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPEMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139252-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPIVACAINE HCL</medicinalproduct>
        <drugbatchnumb>90-335-DK</drugbatchnumb>
        <drugdosagetext>ONCE</drugdosagetext>
        <drugindication>NERVE BLOCK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPIVACAINE HCL</medicinalproduct>
        <drugbatchnumb>90-335-DK</drugbatchnumb>
        <drugdosagetext>ONCE</drugdosagetext>
        <drugindication>PREOPERATIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139253-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.9154</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBULA FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT CREPITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugdosagetext>1 TABLET WEEKLY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19931201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>1 TABLET WEEKLY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139254-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.1834</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugdosagetext>10MG ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SEXUAL DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101130</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139255-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PURDUE-USA-2010-0055943</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</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>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
        <drugtreatmentduration>61</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021745</drugauthorizationnumb>
        <drugdosagetext>200 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE</medicinalproduct>
        <drugdosagetext>50 MG, PRN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERSYL                           /00790702/</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <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>7139256-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>
      <patientweight>74.8435</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERMAL BURN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYREM</medicinalproduct>
        <drugdosagetext>3 GRAM 2 PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NARCOLEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139257-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>81.6475</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HCL AND ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1-2 TABLETS 4-6 HOURS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>KNEE ARTHROPLASTY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HCL AND ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1-2 TABLETS 4-6 HOURS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>KNEE ARTHROPLASTY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>.</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139258-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>68.0396</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HYDROCHLORIDE</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139259-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76.2043</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugdosagetext>1 TABLET ONCE AT BEDTIME PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101130</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139260-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>49.8957</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOX</medicinalproduct>
        <drugindication>SKIN WRINKLING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101109</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139261-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PURDUE-USA-2010-0054302</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>PROSTATE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URETHRAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021745</drugauthorizationnumb>
        <drugdosagetext>300 MG, QD PRN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GOUT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL LIQUI-GELS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139262-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ELI_LILLY_AND_COMPANY-BR201011002006</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENIA</medicinalproduct>
        <drugdosagetext>UNK, 2/D</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>LUNG DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugdosagetext>35 MG, WEEKLY (1/W)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139263-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011007234</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>EVISTA</medicinalproduct>
        <drugauthorizationnumb>020815</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139264-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011007158</companynumb>
    <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>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091020</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139265-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ELI_LILLY_AND_COMPANY-CA201011000875</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>BLOOD CALCIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOLOGICAL MALIGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100323</drugenddate>
        <drugtreatmentduration>554</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139266-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-10P-056-0687877-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL SOUNDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugdosagetext>2-500MG TABS DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRODUODENAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugindication>HELICOBACTER GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OROKEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>2-200MG TABS DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OROKEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>GASTRODUODENAL ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COLCHIMAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100710</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMAREL</medicinalproduct>
        <drugdosagetext>3 DOSAGE FORMS DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVONORM</medicinalproduct>
        <drugdosagetext>FORM STRENGTH: 2MG-2 IN 1 DAY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>FORM STRENGTH: 850MG-3 IN 1 DAY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRETERAX</medicinalproduct>
        <drugdosagetext>1 DOSAGE FORM DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAROXYL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROX</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>TRIMETAZIDINE</medicinalproduct>
        <drugdosagetext>FORM STRENGTH: 20MG 3 IN 1 DAY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugindication>GASTRODUODENAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100708</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugindication>HELICOBACTER GASTRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139267-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-10P-020-0687862-00</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MAMMOPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>DOSE DIMINISHED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</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>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>GASTRIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139268-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-10P-056-0688543-00</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>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIXED LIVER INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIATUS HERNIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLECAINIDE ACETATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXOMIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXOMIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>INSOMNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139269-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ABBOTT-10P-144-0686425-00</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEAL STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081021</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139270-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-10P-062-0688209-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>130</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOZID COMP</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </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>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139271-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-KINGPHARMUSA00001-K201001351</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIPEN</medicinalproduct>
        <drugbatchnumb>9CC792</drugbatchnumb>
        <drugauthorizationnumb>019430</drugauthorizationnumb>
        <drugdosagetext>0.3 MG, SINGLE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANAPHYLACTIC REACTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139272-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAXTER-2010BH028326</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC GANGRENE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101115</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139273-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-GENENTECH-283440</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACUTE LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-HODGKIN'S LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-HODGKIN'S LYMPHOMA RECURRENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>375 MG/M2, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HIV INFECTION CDC GROUP IV SUBGROUP D</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>187.5 MG/M2, Q4W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HIV INFECTION CDC GROUP IV SUBGROUP D</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugdosagetext>12.5 MG/M2, Q4W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HIV INFECTION CDC GROUP IV SUBGROUP D</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>60 MG/M2, Q4W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HIV INFECTION CDC GROUP IV SUBGROUP D</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIRETROVIRALS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139274-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-GENENTECH-292432</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>750 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>220 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MALIGNANT LYMPHOID NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>8800 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MALIGNANT LYMPHOID NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090828</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>6600 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MALIGNANT LYMPHOID NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMIPENEM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090914</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139275-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GENENTECH-310444</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>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULATION FACTOR DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULATION FACTOR V LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULATION FACTOR VII LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULATION FACTOR X LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOMATROPIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>0.035 MG/KG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100416</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139276-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-BAXTER-2010BH028011</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</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139277-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GENENTECH-310447</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIRARUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139278-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-BAXTER-2010BH028986</companynumb>
    <primarysource>
      <reportercountry>INDIA</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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>1002051</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139279-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-09P-028-0601656-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080326</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080226</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080304</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080317</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080323</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139280-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH029253</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>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139281-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0859184A</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>67.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>022251</drugauthorizationnumb>
        <drugdosagetext>100MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
        <drugtreatmentduration>58</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139282-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100809</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0876167A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>022251</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139283-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100809</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0876176A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugauthorizationnumb>022251</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139284-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100817</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0877568A</companynumb>
    <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>THERAPEUTIC RESPONSE UNEXPECTED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugauthorizationnumb>022251</drugauthorizationnumb>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139285-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0877668A</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>OROPHARYNGEAL BLISTERING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022251</drugauthorizationnumb>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139286-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100827</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0878113A</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 ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>022251</drugauthorizationnumb>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPIRONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONOPIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139287-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100827</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0878132A</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>LAMICTAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022251</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139288-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100903</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0879559A</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 INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>022251</drugauthorizationnumb>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139289-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100908</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0880676A</companynumb>
    <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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>022251</drugauthorizationnumb>
        <drugdosagetext>250MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139290-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100913</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0881467A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INITIAL INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>022251</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139291-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0882167A</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>57.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugbatchnumb>175575T</drugbatchnumb>
        <drugauthorizationnumb>022251</drugauthorizationnumb>
        <drugdosagetext>25MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100911</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139292-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0883768A</companynumb>
    <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>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>022251</drugauthorizationnumb>
        <drugdosagetext>275MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139293-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0883777A</companynumb>
    <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>LAMICTAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022251</drugauthorizationnumb>
        <drugdosagetext>300MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139294-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0884228A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>022251</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139295-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101006</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0885230A</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022251</drugauthorizationnumb>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139296-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0885757A</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>EXPIRED DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>022251</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139297-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0885981A</companynumb>
    <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>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>022251</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>500MG UNKNOWN</drugdosagetext>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139298-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0886026A</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>022251</drugauthorizationnumb>
        <drugdosagetext>100MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139299-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0887095A</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 EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>022251</drugauthorizationnumb>
        <drugdosagetext>100MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139300-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0887384A</companynumb>
    <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>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>022251</drugauthorizationnumb>
        <drugdosagetext>200MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139301-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0887388A</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>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>022251</drugauthorizationnumb>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139302-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0887752A</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>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>022251</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139303-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0888334A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugbatchnumb>179105</drugbatchnumb>
        <drugauthorizationnumb>022251</drugauthorizationnumb>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139304-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0888664A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>022251</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139305-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0889136A</companynumb>
    <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>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>022251</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139306-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0889612A</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>022251</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139307-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101029</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0889736A</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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>022251</drugauthorizationnumb>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100930</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139308-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0889988A</companynumb>
    <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 IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022251</drugauthorizationnumb>
        <drugdosagetext>200MGD PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR II DISORDER</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139309-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0890441A</companynumb>
    <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>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugbatchnumb>9ZP8500,161632</drugbatchnumb>
        <drugauthorizationnumb>022251</drugauthorizationnumb>
        <drugdosagetext>25MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139310-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0890560A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>022251</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139311-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101029</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0891027A</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugauthorizationnumb>022251</drugauthorizationnumb>
        <drugdosagetext>100MG TWICE PER DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139312-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-12929BP</companynumb>
    <primarysource>
      <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>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>20101112</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139313-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-12917BP</companynumb>
    <primarysource>
      <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>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139314-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-12928BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <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>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139315-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13718BP</companynumb>
    <primarysource>
      <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>SPIRIVA</medicinalproduct>
        <drugbatchnumb>003484B,0D1008</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139316-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GILEAD-2010-0033973</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139317-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MYLANLABS-2010S1021343</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>74</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARKINSONISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugauthorizationnumb>078443</drugauthorizationnumb>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</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>CETRABEN /01007601/</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-DYDRAMOL</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>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139318-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MYLANLABS-2010S1021343</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>74</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARKINSONISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugauthorizationnumb>077428</drugauthorizationnumb>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</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>CETRABEN /01007601/</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-DYDRAMOL</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>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139319-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-CELGENEUS-056-C5013-10090173</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CC-5013</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CC-5013</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CC-5013</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARDEGIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139320-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010TZ52048</companynumb>
    <primarysource>
      <reportercountry>TANZANIA, UNITED REPUBLIC OF</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COARTEM</medicinalproduct>
        <drugauthorizationnumb>022268</drugauthorizationnumb>
        <drugindication>MALARIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139321-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MYLANLABS-2010S1021418</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugauthorizationnumb>070213</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139322-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010TZ52317</companynumb>
    <primarysource>
      <reportercountry>TANZANIA, UNITED REPUBLIC OF</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COARTEM</medicinalproduct>
        <drugauthorizationnumb>022268</drugauthorizationnumb>
        <drugindication>MALARIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139323-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201007002445</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH LOSS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>020815</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100706</drugenddate>
        <drugtreatmentduration>1558</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139324-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ELI_LILLY_AND_COMPANY-ES201004005363</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A662740C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100407</drugenddate>
        <drugtreatmentduration>131</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBERCAL</medicinalproduct>
        <drugdosagetext>1 D/F, 24HRS</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPIREN</medicinalproduct>
        <drugdosagetext>1 D/F, 24HRS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UROTROL</medicinalproduct>
        <drugdosagetext>1 D/F, 24HRS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugdosagetext>1 D/F, 24HRS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL</medicinalproduct>
        <drugdosagetext>1 D/F, 24HRS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIDROSALURETIL</medicinalproduct>
        <drugdosagetext>1 D/F, 24HRS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139325-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ELI_LILLY_AND_COMPANY-ES201011006444</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101115</drugenddate>
        <drugtreatmentduration>215</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADIRO</medicinalproduct>
        <drugdosagetext>100 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>0.5 D/F, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139326-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE201011006479</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE COMPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIMAGON-D 3</medicinalproduct>
        <drugdosagetext>2 D/F, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139327-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ELI_LILLY_AND_COMPANY-IT201011006498</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139328-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE201011001071</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090817</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139329-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201011006639</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>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, OTHER</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROTIC FRACTURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101115</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONALON</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEVALOTIN /JPN/</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOIPAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANCREATITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPIVERINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONSTAN</medicinalproduct>
        <drugdosagetext>0.4 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAGAMET                            /00397401/</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139330-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010TZ52366</companynumb>
    <primarysource>
      <reportercountry>TANZANIA, UNITED REPUBLIC OF</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COARTEM</medicinalproduct>
        <drugauthorizationnumb>022268</drugauthorizationnumb>
        <drugindication>MALARIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139331-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010TZ52051</companynumb>
    <primarysource>
      <reportercountry>TANZANIA, UNITED REPUBLIC OF</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COARTEM</medicinalproduct>
        <drugauthorizationnumb>022268</drugauthorizationnumb>
        <drugindication>MALARIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139332-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KW-MYLANLABS-2010S1021570</companynumb>
    <primarysource>
      <reportercountry>KUWAIT</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BONE SARCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BONE SARCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>081235</drugauthorizationnumb>
        <drugdosagetext>HIGH-DOSE METHOTREXATE (TOTAL DOSE 144 G/M2)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BONE SARCOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139333-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033349</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.088</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139334-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ALLERGAN-1015497US</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLEPHARAL PIGMENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELASH THICKENING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRIS HYPERPIGMENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUMIGAN</medicinalproduct>
        <drugauthorizationnumb>021275</drugauthorizationnumb>
        <drugdosagetext>1 GTT, QD</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>OPEN ANGLE GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARTEOLOL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>1 GTT, QD</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>OPEN ANGLE GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090404</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYALURONATE SODIUM</medicinalproduct>
        <drugdosagetext>1 GTT, QID</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>KERATOCONJUNCTIVITIS SICCA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETAHISTINE MESILATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIZZINESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOXOPROFEN SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>NECK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITRAZEPAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMETRIDE ANHYDROUS CAFFEINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LACTOSE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139335-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MYLANLABS-2010S1021732</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>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugauthorizationnumb>077121</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTENTIONAL OVERDOSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTENTIONAL OVERDOSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139336-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MYLANLABS-2010S1021732</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUPIL FIXED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugauthorizationnumb>090334</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTENTIONAL OVERDOSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTENTIONAL OVERDOSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139337-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MYLANLABS-2010S1021735</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
        <drugauthorizationnumb>075491</drugauthorizationnumb>
        <drugdosagetext>10 X 300MG CONTROLLED-RELEASE TABLETS.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVERDOSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
        <drugauthorizationnumb>075491</drugauthorizationnumb>
        <drugdosagetext>CONTROLLED-RELEASE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139338-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101006</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US80737</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIACALCIN</medicinalproduct>
        <drugauthorizationnumb>020313</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139340-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-MYLANLABS-2010S1021566</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITROFURANTOIN</medicinalproduct>
        <drugauthorizationnumb>074967</drugauthorizationnumb>
        <drugdosagetext>4DD50MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugdosagetext>1DD150MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIVEC</medicinalproduct>
        <drugdosagetext>1DD400MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100803</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
        <drugdosagetext>1-2DD25MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
        <drugdosagetext>1DD20MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMCINOLONE ACETONIDE</medicinalproduct>
        <drugdosagetext>2DD</drugdosagetext>
        <drugadministrationroute>003</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETOMACROGOL EMULS</medicinalproduct>
        <drugdosagetext>2DD</drugdosagetext>
        <drugadministrationroute>003</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugdosagetext>1DD5MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100705</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNAPAUSE E3</medicinalproduct>
        <drugdosagetext>1DD0,5MG</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100727</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLECALCIFEROL</medicinalproduct>
        <drugdosagetext>1DD1ML</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100716</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139341-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-MYLANLABS-2010S1021566</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITROFURANTOIN</medicinalproduct>
        <drugdosagetext>4DD50MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugauthorizationnumb>076042</drugauthorizationnumb>
        <drugdosagetext>1DD150MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIVEC</medicinalproduct>
        <drugdosagetext>1DD400MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100803</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
        <drugdosagetext>1-2DD25MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
        <drugdosagetext>1DD20MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMCINOLONE ACETONIDE</medicinalproduct>
        <drugdosagetext>2DD</drugdosagetext>
        <drugadministrationroute>003</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETOMACROGOL EMULS</medicinalproduct>
        <drugdosagetext>2DD</drugdosagetext>
        <drugadministrationroute>003</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugdosagetext>1DD5MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100705</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNAPAUSE E3</medicinalproduct>
        <drugdosagetext>1DD0,5MG</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100727</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLECALCIFEROL</medicinalproduct>
        <drugdosagetext>1DD1ML</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100716</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139342-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CL69637</companynumb>
    <primarysource>
      <reportercountry>CHILE</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 PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXFORGE</medicinalproduct>
        <drugauthorizationnumb>021990</drugauthorizationnumb>
        <drugdosagetext>80/5 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILATREND</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139343-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-MYLANLABS-2010S1021587</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</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>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AKATHISIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF-INJURIOUS IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEXUAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
        <drugauthorizationnumb>075577</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080320</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAFERGOT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070817</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070115</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139344-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-MYLANLABS-2010S1021587</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</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>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AKATHISIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF-INJURIOUS IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEXUAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
        <drugauthorizationnumb>075207</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080320</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAFERGOT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070817</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070115</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139345-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-MYLANLABS-2010S1021593</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
        <drugauthorizationnumb>076677</drugauthorizationnumb>
        <drugindication>HOUSE DUST ALLERGY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139346-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100901</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA-2010-0056503</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>149.66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEODYSTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SKIN DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139347-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-AMGEN-NLDSP2010007300</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugbatchnumb>1022626</drugbatchnumb>
        <drugdosagetext>6 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139348-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010004773</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MANTLE CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO CENTRAL NERVOUS SYSTEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>250 A?G, UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100617</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>100 A?G, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100520</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>100 A?G, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>100 A?G, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100527</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>250 A?G, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100603</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>250 A?G, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>250 A?G, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100617</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139349-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MYLANLABS-2010S1021631</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugauthorizationnumb>078224</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEBIVOLOL HCL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040413</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE</medicinalproduct>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010727</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139350-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010RU17845</companynumb>
    <primarysource>
      <reportercountry>RUSSIAN FEDERATION</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ICL670A ICL+DISTAB</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1500 MG, DAILY</drugdosagetext>
        <drugindication>IRON OVERLOAD</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100416</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139351-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MYLANLABS-2010S1021631</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugauthorizationnumb>076418</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEBIVOLOL HCL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040413</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE</medicinalproduct>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010727</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139352-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MYLANLABS-2010S1021631</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugauthorizationnumb>091652</drugauthorizationnumb>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEBIVOLOL HCL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040413</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE</medicinalproduct>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010727</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139353-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-001034</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugbatchnumb>211590F</drugbatchnumb>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>220 MG, OM</drugdosagetext>
        <drugindication>MYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER OPHTHALMOLOGICALS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRANBERRY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139354-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MYLANLABS-2010S1021638</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>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA FACIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMAGNESAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>075876</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN</medicinalproduct>
        <drugdosagetext>REDUCED 5 MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
        <drugdosagetext>REDUCED TO 2.5 MG APPROX 5 WEEKS LATER</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139355-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA57417</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1375 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOMONOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139356-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-MYLANLABS-2010S1021817</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>GLOMERULONEPHRITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>090763</drugauthorizationnumb>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENPROCOUMON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISAPRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLECALCIFEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMILORIDE HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139357-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-MYLANLABS-2010S1021817</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULONEPHRITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOCLASTIC VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>075876</drugauthorizationnumb>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENPROCOUMON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISAPRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLECALCIFEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMILORIDE HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139358-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033990</companynumb>
    <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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080730</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139359-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010003673</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BONE MARROW RETICULIN FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091110</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139360-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-12931BP</companynumb>
    <primarysource>
      <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>FREQUENT BOWEL MOVEMENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</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>20101115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139361-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0688817-00</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>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139362-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-12943BP</companynumb>
    <primarysource>
      <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>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL DRYNESS</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>20101112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>MITRAL VALVE PROLAPSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139363-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-12939BP</companynumb>
    <primarysource>
      <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>NASOPHARYNGITIS</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>20101114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>UNEVALUABLE EVENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIZEM ER</medicinalproduct>
        <drugdosagetext>180 MG</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139364-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-10P-167-0688655-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC SPECIFIC ANTIGEN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROSTAP</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019732</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139365-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13121BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HUNGER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC 75</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020520</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139366-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-10P-087-0648876-00</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>
      <patientweight>52</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER STAGE IV</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPLIN SR FOR INJECTION 11.25 MG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020708</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090804</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER STAGE IV</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091023</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139367-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MYLANLABS-2010S1021832</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>KAPOSI'S SARCOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugauthorizationnumb>075568</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139368-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033977</companynumb>
    <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>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANEXA</medicinalproduct>
        <drugauthorizationnumb>021526</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139369-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0888657A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>022251</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139370-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EC-ALLERGAN-1015566US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLURINOL SYRUP</medicinalproduct>
        <drugauthorizationnumb>021565</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139371-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-JPNCT2010001917</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANITUMUMAB</medicinalproduct>
        <drugdosagetext>6 MG, Q2WK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100914</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANITUMUMAB</medicinalproduct>
        <drugdosagetext>6 MG, Q2WK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100721</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101011</drugenddate>
        <drugtreatmentduration>83</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100721</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100721</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101011</drugenddate>
        <drugtreatmentduration>83</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM LEVOFOLINATE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100721</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENIVACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERDIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139372-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-CCAZA-10112813</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD MAGNESIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFUSE LARGE B-CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZACITIDINE</medicinalproduct>
        <drugauthorizationnumb>050794</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101122</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORINOSTAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101122</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUMS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139373-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-GILEAD-2010-0034033</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANEXA</medicinalproduct>
        <drugauthorizationnumb>021526</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPONIT</medicinalproduct>
        <drugadministrationroute>003</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139374-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033634</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 ARTERIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101114</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139375-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-310597</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>96</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100830</drugenddate>
        <drugtreatmentduration>1279</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139376-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7024398</companynumb>
    <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>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</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>20091001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139377-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7024263</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090527</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139378-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7030177</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030905</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139379-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0689362-00</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>ZEMPLAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020819</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139380-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-10P-087-0688622-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SPINAL CORD INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020478</drugauthorizationnumb>
        <drugdosagetext>MAINTENANCE: 1.5%</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>MAINTENANCE OF ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091014</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139381-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-08P-020-0458047-00</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE EROSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GROIN PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE NODULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT RANGE OF MOTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>702699A02</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>702699A02</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>702699A02</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNCARIA TOMENTOSA/CUPHEA BALSAMONA/MAYTENUS ILICIFOLIA (HERBS)</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1 SOUP SPOON A DAY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>6 TABS IN SEVEN DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLOROQUINE/CODEINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TANDRILAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLEX</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIMESULIDE, RANITIDINE, PARACETAMOL (MAGISTRAL FORMULA)</medicinalproduct>
        <drugdosagetext>NIMESULIDE 100 MG, RANITIDINE 150 MG, AND PARACETAMOL 500MG IN 12 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090715</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL/CYCLOBENZAPRINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTROLIVE</medicinalproduct>
        <drugdosagetext>1.5 MG/ 1.2 MG</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTROLIVE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISADOR</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MANEVIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAL D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139382-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-10P-028-0683413-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50.848</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>160 MG AT WEEK 0</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>1 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>40 MG QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139383-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033998</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>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101122</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139384-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0029563</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>45.854</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugbatchnumb>FEN006</drugbatchnumb>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIGAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAVATAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAG CITRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139385-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-WATSON-2010-15333</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>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>072926</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SUICIDE ATTEMPT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BROMISOVAL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SUICIDE ATTEMPT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139386-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-WATSON-2010-15332</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS B</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNE RECONSTITUTION SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>080521</drugauthorizationnumb>
        <drugdosagetext>20 MG/KG, DAILY</drugdosagetext>
        <drugindication>TUBERCULOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS AGAINST HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFAMPICIN</medicinalproduct>
        <drugdosagetext>20 MG/KG, DAILY</drugdosagetext>
        <drugindication>TUBERCULOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PYRAZINAMIDE</medicinalproduct>
        <drugdosagetext>40 MG/KG, DAILY</drugdosagetext>
        <drugindication>TUBERCULOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHAMBUTOL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>20 MG/KG, DAILY</drugdosagetext>
        <drugindication>TUBERCULOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BCG                                /00002001/</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>IMMUNISATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOPINAVIR/RITONAVIR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139387-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-WATSON-2010-15339</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>ATRIOVENTRICULAR BLOCK COMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QRS COMPLEX PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE ABSENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>076928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139388-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-WATSON-2010-15675</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>074217</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ARRHYTHMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139389-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-WATSON-2010-15338</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>IMMUNE RECONSTITUTION SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>080521</drugauthorizationnumb>
        <drugdosagetext>250 MG, DAILY</drugdosagetext>
        <drugindication>DISSEMINATED TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFAMPIN</medicinalproduct>
        <drugdosagetext>600 MG, DAILY</drugdosagetext>
        <drugindication>DISSEMINATED TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PYRAZINAMIDE</medicinalproduct>
        <drugdosagetext>1500 MG, DAILY</drugdosagetext>
        <drugindication>DISSEMINATED TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHAMBUTOL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>750 MG, DAILY</drugdosagetext>
        <drugindication>DISSEMINATED TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugdosagetext>275 MG, SINGLE X 3 DOSES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139390-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-WATSON-2010-15685</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>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>018832</drugauthorizationnumb>
        <drugdosagetext>200 MG, DAILY</drugdosagetext>
        <drugindication>HYPERURICAEMIA</drugindication>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>018832</drugauthorizationnumb>
        <drugdosagetext>100 MG, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE (WATSON LABORATORIES)</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139391-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-WATSON-2010-15664</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>PORPHYRIA NON-ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>070929</drugauthorizationnumb>
        <drugdosagetext>20 MG, DAILY</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139392-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-WATSON-2010-15245</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL-50</medicinalproduct>
        <drugbatchnumb>285605A</drugbatchnumb>
        <drugauthorizationnumb>076709</drugauthorizationnumb>
        <drugdosagetext>1 PATCH, Q 72 HOURS</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101122</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL-50</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>076709</drugauthorizationnumb>
        <drugdosagetext>1 PATCH, Q 72 HOURS</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139393-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-WATSON-2010-15680</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIA XT (WATSON LABORATORIES)</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>074852</drugauthorizationnumb>
        <drugdosagetext>15 MG, Q1H</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugdosagetext>25 MCG/HOUR, TITRATED UP TO 350 MCG/HOUR OVER A 24-DAY PERIOD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugdosagetext>20 MG, Q1H</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPROMAZINE</medicinalproduct>
        <drugdosagetext>25 MG, Q4H</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>0.125 M [SIC] EVERY 48 HOURS</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE</medicinalproduct>
        <drugdosagetext>100 MG, EVERY 12 HOURS</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>60 MG, SINGLE</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugdosagetext>1600 UNITS, Q1H</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
        <drugdosagetext>0.5 MG, Q6H</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVALBUTEROL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>0.63 MG, Q6H</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>7.5 MG, Q6H</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIPERACILLIN W/TAZOBACTAM</medicinalproduct>
        <drugdosagetext>4.5 MG, EVERY 12 HOURS</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOBRAMYCIN</medicinalproduct>
        <drugdosagetext>300 MG, EVERY 12 HOURS</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139394-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2010SE46725</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGOHYDRAMNIOS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRE-ECLAMPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND HCT</medicinalproduct>
        <drugauthorizationnumb>021093</drugauthorizationnumb>
        <drugdosagetext>16/12.5 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORASEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090720</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139395-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2010SE46925</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CRYPTORCHISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKULL MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TALIPES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND HCT</medicinalproduct>
        <drugauthorizationnumb>021093</drugauthorizationnumb>
        <drugdosagetext>16/12.5 MG/ DAILY</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORASEMIDE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139396-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-GILEAD-E2B_00000924</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPSERA</medicinalproduct>
        <drugauthorizationnumb>021449</drugauthorizationnumb>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPSERA</medicinalproduct>
        <drugauthorizationnumb>021449</drugauthorizationnumb>
        <drugdosagetext>7.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139397-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7029799</companynumb>
    <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>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139398-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7029833</companynumb>
    <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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC MASS</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>20080528</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139399-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GENENTECH-297354</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>33</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VESTIBULAR NEURONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>300 MG, 1/MONTH</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>300 MG, 1/MONTH</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091022</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLO-PHYLLIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL/IPRATROPIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONTELUKAST</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139400-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GENENTECH-310336</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR LYSIS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>25 MG, 2/WEEK</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>BURKITT'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARA-C</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>50 MG, 3/WEEK</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>BURKITT'S LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139401-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GENENTECH-310359</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139402-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SK-GENENTECH-309795</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>OMALIZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101011</drugenddate>
        <drugtreatmentduration>1757</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139403-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2010154414</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOPRIL /BRA/</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURAN T4</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHONDROITIN/GLUCOSAMINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139404-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2010153034</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>POLYURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139405-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010155873</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>41.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELECOX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>100 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100903</drugenddate>
        <drugtreatmentduration>112</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYRADIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLETAL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEVALOTIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100831</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139406-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2010154444</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101026</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELOKEN</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139407-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2010154439</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139408-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2010147686</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>SKIN TEST NEGATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090406</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFERALGAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090406</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPLEXIL ^SPECIA^</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090406</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139409-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010153777</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>90.703</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COELIAC DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>1 UNK, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139410-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010126796</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>
      <patientweight>64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELECOX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>200 MG, UNKNOWN/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100908</drugenddate>
        <drugtreatmentduration>646</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUTASTERIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URIEF</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYRADIN S</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMETEC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100909</drugenddate>
        <drugtreatmentduration>827</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEZOLMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100904</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100908</drugenddate>
        <drugtreatmentduration>826</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESILATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESILATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100909</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NATRIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORASEMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100904</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139411-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010155596</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>56.689</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugbatchnumb>D38415</drugbatchnumb>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>Q2H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOOTHACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139412-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100520</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2010136095</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>80 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139413-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-GENENTECH-309749</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101018</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURAN T4</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>112 A?G, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139414-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-10P-028-0688257-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>6007033</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100219</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139415-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-10P-062-0687729-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BUNION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACEMETACIN</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139416-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ABBOTT-10P-114-0687795-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYE INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAPULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN PLAQUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139417-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100512</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-10P-028-0644854-00</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018874</drugauthorizationnumb>
        <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>PANCREALIPASE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139418-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-WATSON-2010-15353</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>080356</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MIXED CONNECTIVE TISSUE DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugauthorizationnumb>080356</drugauthorizationnumb>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139419-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-WATSON-2010-15364</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>2.665</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPAFENONE HCL</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>075203</drugauthorizationnumb>
        <drugdosagetext>10 MG/KG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPRAVENTRICULAR TACHYCARDIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139420-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SK-WATSON-2010-15357</companynumb>
    <primarysource>
      <reportercountry>SLOVAKIA (Slovak Republic)</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>POLYMYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRELSTAR UNKNOWN STRENGTH (WATSON LABORATORIES)</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>020715</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>INFERTILITY FEMALE</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139421-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-WATSON-2010-15349</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>GASTROENTERITIS EOSINOPHILIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL MUCOSAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>063181</drugauthorizationnumb>
        <drugdosagetext>200 MG, DAILY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRURITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070825</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139422-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-WATSON-2010-15362</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>2.94</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPAFENONE HCL</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>075203</drugauthorizationnumb>
        <drugdosagetext>10 MG/KG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPRAVENTRICULAR TACHYCARDIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139423-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-WATSON-2010-15360</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>HAEMODYNAMIC INSTABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAPAMIL HCL</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>070994</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>INTENTIONAL OVERDOSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139424-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-WATSON-2010-15365</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>2.15</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPAFENONE HCL</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>075203</drugauthorizationnumb>
        <drugdosagetext>10 MG/KG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPRAVENTRICULAR TACHYCARDIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139425-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-WATSON-2010-15352</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>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>080727</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POISONING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POISONING</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139426-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010128165</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>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVELOPMENTAL DELAY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA INFECTIOSUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART DISEASE CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG HYPERINFLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS MEDIA ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER DEVELOPMENTAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNDERWEIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugdosagetext>300 MG, EVERY DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANCEF</medicinalproduct>
        <drugdosagetext>275 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>10 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEFLEX</medicinalproduct>
        <drugdosagetext>550 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139427-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010074506</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
        <drugdosagetext>1 GTT, 1X/DAY</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139428-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007086207</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMMUNICATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING DRUNK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAIL GROWTH ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSAL DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 2X/DAY</drugdosagetext>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>POST HERPETIC NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYSINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIDOPHILUS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139429-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2009249348</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>004782</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139430-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010159842</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>100 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugdosagetext>0.1 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139431-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-PFIZER INC-2010164201</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugauthorizationnumb>018972</drugauthorizationnumb>
        <drugdosagetext>600 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA SUPRAVENTRICULAR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100129</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugauthorizationnumb>018972</drugauthorizationnumb>
        <drugdosagetext>400 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100130</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugauthorizationnumb>018972</drugauthorizationnumb>
        <drugdosagetext>200 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100131</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL SULFATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOVEGIN PRO INJECTIONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100126</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139432-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2010127626</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT SOLUBILITY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>40 MG, 1X/DAY, 1 TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIZIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>OSTEOPENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139433-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010032780</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>26</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SILDENAFIL CITRATE</medicinalproduct>
        <drugauthorizationnumb>021845</drugauthorizationnumb>
        <drugdosagetext>0.4 MG, EVERY 4 HRS</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100302</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SILDENAFIL CITRATE</medicinalproduct>
        <drugauthorizationnumb>021845</drugauthorizationnumb>
        <drugdosagetext>1 MG/KG/DAY, EVERY 4 HRS (INJECTION INTO STOMACH)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100305</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
        <drugdosagetext>6 MG/KG/MIN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100505</drugenddate>
        <drugtreatmentduration>65</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MILRILA</medicinalproduct>
        <drugdosagetext>1 MG/KG/DAY (0.25 UG/KG/MIN)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100311</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MILRILA</medicinalproduct>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOPAMINE HCL</medicinalproduct>
        <drugdosagetext>11 MG/KG/DAY (3 UG/KG/MIN)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100312</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOBUTREX</medicinalproduct>
        <drugdosagetext>11 MG/KG/DAY (3 UG/KG/MIN)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100312</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRIC OXIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139434-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160512</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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugdosagetext>80 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139435-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160646</companynumb>
    <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</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR INFECTION FUNGAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTIVERT</medicinalproduct>
        <drugauthorizationnumb>010721</drugauthorizationnumb>
        <drugindication>VERTIGO</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139436-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010114436</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>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</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>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>LIMB DISCOMFORT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERZONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONTELUKAST</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE</medicinalproduct>
        <drugdosagetext>50 UG, AS NEEDED</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139437-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2010157734</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>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, (2X75 MG IN THE MORNING/1X75 MG IN THE EVENING)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugdosagetext>16.8 MG, (100 UG/H ACTIVE SUBSTANCE RELEASE) EVERY 3 DAYS</drugdosagetext>
        <drugadministrationroute>003</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080818</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIC</medicinalproduct>
        <drugdosagetext>150 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugdosagetext>120 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOL</medicinalproduct>
        <drugdosagetext>1 DF, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139438-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010121164</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugauthorizationnumb>020280</drugauthorizationnumb>
        <drugdosagetext>2 MG, 1X/DAY</drugdosagetext>
        <drugindication>GROWTH RETARDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101019</drugenddate>
        <drugtreatmentduration>49</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugauthorizationnumb>020280</drugauthorizationnumb>
        <drugdosagetext>2 MG, DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101019</drugenddate>
        <drugtreatmentduration>49</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MERCAPTOPURINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFAXIMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139439-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007069785</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>79.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>88 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139440-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2010160136</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAHOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAHOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>80 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100814</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>200 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100814</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139441-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010157246</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>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugauthorizationnumb>012151</drugauthorizationnumb>
        <drugdosagetext>25 MG, 1X/DAY</drugdosagetext>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139442-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2010157722</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>LOW DOSE, MG UNITS, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100926</drugenddate>
        <drugtreatmentduration>279</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>LOW DOSE, MG UNITS, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100926</drugenddate>
        <drugtreatmentduration>279</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED *NO SUBJECT DRUG</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>LOW DOSE, MG UNITS, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100926</drugenddate>
        <drugtreatmentduration>279</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED *PLACEBO</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>LOW DOSE, MG UNITS, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100926</drugenddate>
        <drugtreatmentduration>279</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>LOW DOSE, MG UNITS, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100926</drugenddate>
        <drugtreatmentduration>279</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>LOW DOSE, MG UNITS, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100926</drugenddate>
        <drugtreatmentduration>279</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>LOW DOSE, MG UNITS, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100926</drugenddate>
        <drugtreatmentduration>279</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </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>BLINDED *NO SUBJECT DRUG</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED *PLACEBO</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <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>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>20 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100926</drugenddate>
        <drugtreatmentduration>279</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139443-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HU-PFIZER INC-2010151911</companynumb>
    <primarysource>
      <reportercountry>HUNGARY</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139444-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2009250360</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugauthorizationnumb>012151</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090520</drugenddate>
        <drugtreatmentduration>38</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugauthorizationnumb>012151</drugauthorizationnumb>
        <drugindication>MITRAL VALVE INCOMPETENCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090520</drugenddate>
        <drugtreatmentduration>38</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090703</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090520</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090703</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139445-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2010160924</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY, ONCE DAILY, 4 WEEKS ON, TWO WEEKS OFF</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUTHYROX</medicinalproduct>
        <drugdosagetext>1 PILL, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETROL</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
        <drugdosagetext>5 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>0.4 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARVEA</medicinalproduct>
        <drugdosagetext>300 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORASEMIDE</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139446-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2009270887</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.678</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY CHANGE</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>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</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>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE</medicinalproduct>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORDIAZEPOXIDE</medicinalproduct>
        <drugdosagetext>25 MG, 1X/DAY</drugdosagetext>
        <drugindication>MENTAL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugdosagetext>145 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARMODAFINIL</medicinalproduct>
        <drugdosagetext>250 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SOMNOLENCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>0.4 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATOMEGALY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139447-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010164189</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>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLENE BLUE</medicinalproduct>
        <drugdosagetext>THERAPY DURATION-ONCE 7 MG/KG</drugdosagetext>
        <drugindication>PARATHYROIDECTOMY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139448-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010095096</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>
      <patientweight>57.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUNITINIB MALATE</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091002</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMAC /JPN/</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091002</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139449-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010094973</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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULAR FILTRATION RATE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIKOSYN</medicinalproduct>
        <drugauthorizationnumb>020931</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIKOSYN</medicinalproduct>
        <drugauthorizationnumb>020931</drugauthorizationnumb>
        <drugdosagetext>0.5MG IN THE MORNING; 0.25MG IN EENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139450-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-PFIZER INC-2010102910</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>74</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOBULINS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>80 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOVASCULAR EVENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139451-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160841</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>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RELISTOR</medicinalproduct>
        <drugauthorizationnumb>021964</drugauthorizationnumb>
        <drugdosagetext>8 MG, ALTERNATE DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
        <drugdosagetext>8 MG, UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAFFEINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugdosagetext>750 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARAFATE</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139452-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010092573</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>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLEFT LIP AND PALATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENURESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EUSTACHIAN TUBE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS MEDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN PAPILLOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VELOPHARYNGEAL INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139453-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010157305</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>150 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101124</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139454-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010128154</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CLEFT PALATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EUSTACHIAN TUBE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FINE MOTOR DELAY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEARING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS MEDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKULL MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER DEVELOPMENTAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEFLEX</medicinalproduct>
        <drugdosagetext>500 MG, TWO CAPSULE</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060817</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN LOWER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060602</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139455-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PFIZER INC-2010157931</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RELPAX</medicinalproduct>
        <drugauthorizationnumb>021016</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139456-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2010121992</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>
      <patientweight>110</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOMATROPIN RDNA</medicinalproduct>
        <drugauthorizationnumb>020280</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, 1X/DAY</drugdosagetext>
        <drugindication>HYPOPITUITARISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080402</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>50 UG,DAILY</drugdosagetext>
        <drugindication>BLOOD THYROID STIMULATING HORMONE DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRIMARY HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugdosagetext>30 MG, 2X/DAY</drugdosagetext>
        <drugindication>BLOOD CORTICOTROPHIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030403</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugdosagetext>200 MG, 2X/DAY</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVREDOL</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIZOTIFEN</medicinalproduct>
        <drugdosagetext>0.5 MG, 3X/DAY</drugdosagetext>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE PHOSPHATE</medicinalproduct>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030203</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139457-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010153818</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSCILLOPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>25 MG, A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139458-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010140929</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL BLISTERING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugbatchnumb>167542</drugbatchnumb>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101026</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>1 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MUSCLE SPASMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugindication>INTERVERTEBRAL DISC DEGENERATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139459-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010133603</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>
      <patientweight>51</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SILDENAFIL CITRATE</medicinalproduct>
        <drugauthorizationnumb>021845</drugauthorizationnumb>
        <drugdosagetext>20 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080828</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SILDENAFIL CITRATE</medicinalproduct>
        <drugauthorizationnumb>021845</drugauthorizationnumb>
        <drugdosagetext>20 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100121</drugenddate>
        <drugtreatmentduration>507</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139460-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-PFIZER INC-2010157787</companynumb>
    <primarysource>
      <reportercountry>IRELAND</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>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 2X/DAY</drugdosagetext>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139461-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010092584</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.199</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART DISEASE CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATENT DUCTUS ARTERIOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVALVULAR AORTIC STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UMBILICAL CORD ABNORMALITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>25 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061219</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>100 MG, HALF TABLET DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081017</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
        <drugdosagetext>180 UG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139462-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2010162376</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPULSIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VARENICLINE TARTRATE</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139463-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2010137485</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>252</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR ICTERUS</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>20090801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugindication>LEFT VENTRICULAR FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>2.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL</medicinalproduct>
        <drugdosagetext>2.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090815</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139464-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2010121999</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>105</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOMATROPIN RDNA</medicinalproduct>
        <drugauthorizationnumb>020280</drugauthorizationnumb>
        <drugdosagetext>WEEKLY, (7 INJECTIONS PER WEEK)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HYPOPITUITARISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>5 G, 3X/DAY</drugdosagetext>
        <drugindication>ANTIINFLAMMATORY THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAVISCON</medicinalproduct>
        <drugdosagetext>10 ML, UNK</drugdosagetext>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060725</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETODOLAC</medicinalproduct>
        <drugdosagetext>600 MG, DAILY</drugdosagetext>
        <drugindication>ANTIINFLAMMATORY THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060725</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL</medicinalproduct>
        <drugdosagetext>100 MG, AS NEEDED</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060721</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN</medicinalproduct>
        <drugdosagetext>400 UG, DAILY</drugdosagetext>
        <drugindication>URINARY RETENTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEZAFIBRATE</medicinalproduct>
        <drugdosagetext>200 MG, DAILY</drugdosagetext>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060725</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139465-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2010161152</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>WRONG DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FRONTAL XR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101127</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugdosagetext>0.25MG  AM AND 0.5MG PM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139466-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010144042</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>58.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugauthorizationnumb>050784</drugauthorizationnumb>
        <drugdosagetext>500 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101010</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLORIC ^GLAXO WELLCOME^</medicinalproduct>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD URIC ACID</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139467-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010159868</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139468-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-PFIZER INC-2010163866</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>ANTICHOLINERGIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugauthorizationnumb>011459</drugauthorizationnumb>
        <drugdosagetext>25 MG, 2X/DAY (20 TABLETS)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EATING DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FARGANESSE</medicinalproduct>
        <drugdosagetext>25 MG, 1X/DAY (20 TABLETS)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EATING DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELISON</medicinalproduct>
        <drugdosagetext>30 MG, 1X/DAY (30 CAPSULES)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EATING DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139469-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010085207</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>
      <reaction>
        <reactionmeddrapt>HOSTILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080128</drugenddate>
        <drugtreatmentduration>53</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139470-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-PFIZER INC-2010103771</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QRS COMPLEX PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>019787</drugauthorizationnumb>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>1200 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACENOCOUMAROL</medicinalproduct>
        <drugdosagetext>98 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
        <drugdosagetext>7.125 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COVERSYL</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOTALOL HCL</medicinalproduct>
        <drugdosagetext>7200 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROMOCARD</medicinalproduct>
        <drugdosagetext>6000 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>800 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139471-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010157315</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>30.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOMATROPIN RDNA</medicinalproduct>
        <drugauthorizationnumb>020280</drugauthorizationnumb>
        <drugdosagetext>1.2 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>BODY HEIGHT BELOW NORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101120</drugenddate>
        <drugtreatmentduration>387</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugdosagetext>18 MG, 1X/DAY, SCHOOL DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101120</drugenddate>
        <drugtreatmentduration>467</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>50 MCG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061102</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139472-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-JP-WYE-H18104510</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>53.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS OBLITERANS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOREA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED SELF-CARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>004782</drugauthorizationnumb>
        <drugdosagetext>0.625 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19750101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMODIAN-DEPOT</medicinalproduct>
        <drugdosagetext>1 MG, 2X/WEEK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19630101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMODIAN-DEPOT</medicinalproduct>
        <drugdosagetext>1 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugdosagetext>5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUP-4</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTERIOSCLEROSIS OBLITERANS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139473-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010152776</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>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTMENOPAUSAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>1 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139474-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PFIZER INC-2010158389</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139475-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160807</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>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HANGOVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugdosagetext>UP TO 1MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>UP TO 1MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139476-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007086650</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>084349</drugauthorizationnumb>
        <drugdosagetext>400 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139477-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2009280122</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.492</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA SUPRAVENTRICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIKOSYN</medicinalproduct>
        <drugauthorizationnumb>020931</drugauthorizationnumb>
        <drugdosagetext>250 UG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL TACHYCARDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080728</drugenddate>
        <drugtreatmentduration>1041</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIKOSYN</medicinalproduct>
        <drugauthorizationnumb>020931</drugauthorizationnumb>
        <drugdosagetext>125 UG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TACHYCARDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080729</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIKOSYN</medicinalproduct>
        <drugauthorizationnumb>020931</drugauthorizationnumb>
        <drugdosagetext>250 UG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugdosagetext>1 MG, 1X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MURO 128</medicinalproduct>
        <drugindication>CORNEAL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALKALOL</medicinalproduct>
        <drugdosagetext>FREQUENCY: 2X/DAY,</drugdosagetext>
        <drugindication>SINUS DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHINOCORT</medicinalproduct>
        <drugdosagetext>FREQUENCY: 2X/DAY,</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugtreatmentduration>3650</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM/VITAMIN D/VITAMIN K</medicinalproduct>
        <drugdosagetext>500 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>81 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>81 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORHEXIDINE GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYNACIRC</medicinalproduct>
        <drugdosagetext>5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugdosagetext>2.5 MG, 1X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>80 MG, 1X/DAY</drugdosagetext>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>80 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>5 MG, 2X/DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>25 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACIDOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISPAGHULA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139478-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-PFIZER INC-2010159310</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>150 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND HYDROCODONE BITARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139479-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010149873</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>150 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101115</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLELOCK</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139480-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010124492</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>BLEPHAROSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>150 MG / DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139481-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-PFIZER INC-2010162106</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</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>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>20 MG, ALTERNATE DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139482-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-US-WYE-H18436610</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>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTISOCIAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MAJOR DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>.25 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101006</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, 1X/DAY</drugdosagetext>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugdosagetext>2 PUFF 2X/DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>.075 MG, 1X/DAY</drugdosagetext>
        <drugindication>BLOOD IRON DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>1200 MG, 1X/DAY</drugdosagetext>
        <drugindication>BLOOD CALCIUM DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>2.5 MG, 1X/DAY</drugdosagetext>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBANDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>150 MG, MONTHLY</drugdosagetext>
        <drugindication>BONE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESYREL</medicinalproduct>
        <drugdosagetext>50 UNK, UNK</drugdosagetext>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugindication>ANTIDEPRESSANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugindication>ANTIDEPRESSANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 3</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139483-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160790</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>ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugdosagetext>0.25 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139484-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010049748</companynumb>
    <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>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugbatchnumb>00069098038</drugbatchnumb>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY, FOR 28 DAYS EVERY 42 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139485-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2010157767</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>1100</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE CONGENITAL ABNORMALITIES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139486-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-PFIZER INC-2010150126</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugdosagetext>15 MG, TOTAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100910</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugdosagetext>20 ML, TOTAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100910</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORMETAZEPAM</medicinalproduct>
        <drugdosagetext>40 ML TOTAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100910</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugdosagetext>50 UNIT DOSE TOTAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100910</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENAPREN</medicinalproduct>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MODURETIC 5-50</medicinalproduct>
        <drugdosagetext>1 UNIT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139487-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010132698</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>2 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100928</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139488-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033908</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugauthorizationnumb>021752</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARUNAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139489-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ASTRAZENECA-2010SE54705</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18891</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS NEUROSENSORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101115</drugenddate>
        <drugtreatmentduration>543</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139490-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2010SE55566</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR ICTERUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</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>1</drugcharacterization>
        <medicinalproduct>STAGID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAMICRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139491-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2010SE53661</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>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081129</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081220</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
        <drugtreatmentduration>650</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLETAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100930</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139492-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2010SE57345</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>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139493-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0031157</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>COR PULMONALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugbatchnumb>CDC</drugbatchnumb>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090417</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139495-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201041985NA</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE INJURIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASYLOL</medicinalproduct>
        <drugauthorizationnumb>020304</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061025</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139496-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0032943</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>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091112</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139497-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033975</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 OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101128</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139498-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-10P-087-0689546-00</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>PLACENTA ACCRETA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020478</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>GENERAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCURONIUM BROMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GENERAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTIVA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GENERAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GENERAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101012</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139499-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-10P-028-0688342-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAVIK</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020528</drugauthorizationnumb>
        <drugdosagetext>2MG DAILY</drugdosagetext>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100625</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>B BLOCKER</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139500-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0687286-00</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPRON DEPOT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020011</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139501-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-10P-087-0686792-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.35</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020478</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCURONIUM BROMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPHEDRINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>BLOOD ANTIDIURETIC HORMONE DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYLEPHRINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>BLOOD ANTIDIURETIC HORMONE DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101012</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139502-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0688141-00</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>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPRON DEPOT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020011</drugauthorizationnumb>
        <drugindication>ENDOMETRIOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPRON DEPOT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020011</drugauthorizationnumb>
        <drugindication>CYST RUPTURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORMONE REPLACEMENT</medicinalproduct>
        <drugindication>HYSTERECTOMY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139503-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-WATSON-2010-15430</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUBIS FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>076984</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugtreatmentduration>2920</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139504-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-WATSON-2010-15439</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OBSESSIVE THOUGHTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>077034</drugauthorizationnumb>
        <drugdosagetext>40 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101104</drugenddate>
        <drugtreatmentduration>58</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZAPAIN</medicinalproduct>
        <drugdosagetext>1 DF, QID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101005</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139505-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-WATSON-2010-15251</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>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL (ALTACE)</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>076549</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugdosagetext>20 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NORMAL PRESSURE HYDROCEPHALUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>1 DF, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELPERONE</medicinalproduct>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NORMAL PRESSURE HYDROCEPHALUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139506-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-WATSON-2010-15335</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>PURULENT DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
        <drugbatchnumb>27170</drugbatchnumb>
        <drugauthorizationnumb>076709</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139507-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-WATSON-2010-15369</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY LOSS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>076794</drugauthorizationnumb>
        <drugdosagetext>500 MG, BID FOR 10 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100725</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugdosagetext>25 MG, Q8H PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100721</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE AND ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1 TABLET, Q6H PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100721</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139508-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-WATSON-2010-13615</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugbatchnumb>07077A</drugbatchnumb>
        <drugauthorizationnumb>076685</drugauthorizationnumb>
        <drugdosagetext>20-40 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080117</drugenddate>
        <drugtreatmentduration>855</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139509-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-WATSON-2010-14483</companynumb>
    <primarysource>
      <reportercountry>POLAND</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>DRUG ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDO-BARTTER SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE (WATSON LABORATORIES)</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>070449</drugauthorizationnumb>
        <drugdosagetext>2-30 TABLETS DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG ABUSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL                            /00002101/</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SOCIAL ALCOHOL DRINKER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139510-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BF-WATSON-2010-14859</companynumb>
    <primarysource>
      <reportercountry>BURKINA FASO</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>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN TABLETS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139511-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-WATSON-2010-00969</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAFLO</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>022206</drugauthorizationnumb>
        <drugdosagetext>4 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091230</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPLIN</medicinalproduct>
        <drugdosagetext>3.75 MG, DAILY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091201</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
        <drugdosagetext>80 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091230</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMOX</medicinalproduct>
        <drugdosagetext>300 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091228</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALONAL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091228</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DASEN</medicinalproduct>
        <drugdosagetext>30 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091228</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSOLVAN                         /00546001/</medicinalproduct>
        <drugdosagetext>45 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091228</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE PHOSPHATE</medicinalproduct>
        <drugdosagetext>3 G, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091228</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HOKUNALIN  TAPE</medicinalproduct>
        <drugdosagetext>2 MG, DAILY</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091228</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMEDIN                          /00274301/</medicinalproduct>
        <drugdosagetext>INTRAVENOUS DRIP</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100103</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER                             /00706001/</medicinalproduct>
        <drugdosagetext>20 MG, INTRAVENOUS DRIP</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100104</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AFTACH</medicinalproduct>
        <drugdosagetext>TAKEN AS NEEDED 1 OR 2 TAB/DAY</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100107</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139512-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-GENENTECH-310339</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>750 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>750 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1650 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1575 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1575 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>110 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>105 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>105 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>G-CSF</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>6 MG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>G-CSF</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>6 MG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101117</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139513-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GENENTECH-310327</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1 G, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101104</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139514-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GENENTECH-310297</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>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUTROPIN AQ</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020522</drugauthorizationnumb>
        <drugdosagetext>1.2 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GROWTH RETARDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100902</drugenddate>
        <drugtreatmentduration>94</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUTROPIN AQ</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020522</drugauthorizationnumb>
        <drugdosagetext>1.3 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100902</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139515-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-QUU443736</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ADVERSE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>300 A?G, QOD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>NEUTROPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOXYMETHYLPENICILLIN</medicinalproduct>
        <drugdosagetext>250 MG, BID</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139516-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-JPNCT2010007291</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>
      <patientweight>40</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS ACNEIFORM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARONYCHIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANITUMUMAB</medicinalproduct>
        <drugdosagetext>6 MG/KG, Q2WK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101013</drugenddate>
        <drugtreatmentduration>84</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101003</drugenddate>
        <drugtreatmentduration>74</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHISTAMINES</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASPORT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYSLEE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMITT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GOSHAJINKIGAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOFERMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAXOBERON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139517-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN INC.-QUU443746</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSFUSION REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>.5 A?G/KG, UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100702</drugenddate>
        <drugtreatmentduration>85</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROID NOS</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100317</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139518-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USACT2010006178</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>DENOSUMAB</medicinalproduct>
        <drugdosagetext>60 MG, Q6MO</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OS-CAL + D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139519-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN GMBH-QUU418411</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>5Q MINUS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILE DUCT CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugbatchnumb>1014755</drugbatchnumb>
        <drugdosagetext>7 A?G, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091209</drugenddate>
        <drugtreatmentduration>834</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugbatchnumb>1013900</drugbatchnumb>
        <drugdosagetext>7 A?G, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100412</drugenddate>
        <drugtreatmentduration>71</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugbatchnumb>1017868</drugbatchnumb>
        <drugdosagetext>8 A?G, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100419</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugbatchnumb>1013900</drugbatchnumb>
        <drugdosagetext>9 A?G, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101230</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE AND ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>UNK UNK, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENALIDOMIDE</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100121</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139520-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-AMGEN-UK366217</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANAEMIA OF CHRONIC DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PARATHYROID HORMONE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>100 UNK, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050714</drugenddate>
        <drugtreatmentduration>58</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugdosagetext>150 UNK, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061019</drugenddate>
        <drugtreatmentduration>524</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugdosagetext>200 UNK, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070502</drugenddate>
        <drugtreatmentduration>206</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugdosagetext>150 UNK, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070919</drugenddate>
        <drugtreatmentduration>141</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugdosagetext>200 UNK, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIMPARA</medicinalproduct>
        <drugdosagetext>180 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTHANUM CARBONATE</medicinalproduct>
        <drugdosagetext>1 G, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVELAMER</medicinalproduct>
        <drugdosagetext>800 MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFACALCIDOL</medicinalproduct>
        <drugdosagetext>1 A?G, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOXIDIL</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugdosagetext>40 MG, BID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN</medicinalproduct>
        <drugdosagetext>8 MG, BID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORLISTAT</medicinalproduct>
        <drugdosagetext>120 MG, TID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS FUMARATE</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEMINAL WITH C FORTIS</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139521-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CH78087</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, DAILY</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FASLODEX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139522-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2009US01058</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE MARROW TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>2000 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNOSUPPRESSANTS</medicinalproduct>
        <drugindication>BONE MARROW TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139523-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US74154</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>2000 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SICKLE CELL ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139524-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US31289</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>39</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1000 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SICKLE CELL ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugdosagetext>45 MCG: 21MCG, 2 PUFFS BID</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>1 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYUREA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULFATE</medicinalproduct>
        <drugdosagetext>90 MCG, 2 PUFFS/ 4-6 HOURS</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139525-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US80047</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MOTOR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LYMPHOPROLIFERATIVE DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139526-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033974</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>ISCHAEMIC STROKE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101108</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139527-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101121</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-018888-10</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBUTEX</medicinalproduct>
        <drugauthorizationnumb>020732</drugauthorizationnumb>
        <drugdosagetext>DOSING DETAILS UNKNOWN.</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139528-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-013052-10</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>020733</drugauthorizationnumb>
        <drugdosagetext>DOSING INFORMATION UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>020733</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN DSOING DETAILS</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139529-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-018736-10</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>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>020733</drugauthorizationnumb>
        <drugdosagetext>DOSING INFORMATION UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139530-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-018788-10</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 EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>020732</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG DEPENDENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100805</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBUTEX</medicinalproduct>
        <drugauthorizationnumb>020732</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG DEPENDENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100806</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139531-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-014454-10</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 EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE LABOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE RUPTURE OF MEMBRANES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>020732</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG DEPENDENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100805</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBUTEX</medicinalproduct>
        <drugauthorizationnumb>020732</drugauthorizationnumb>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>DRUG DEPENDENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100806</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139532-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-017079-10</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>ANTICOAGULATION DRUG LEVEL ABOVE THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTICOAGULATION DRUG LEVEL BELOW THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>022410</drugauthorizationnumb>
        <drugdosagetext>DOSING INFORMATION UNKNOWN / SUBLINGUAL FILM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugauthorizationnumb>022410</drugauthorizationnumb>
        <drugdosagetext>DOSAGE UNKNOWN AT THIS TIME.</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139533-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-015598-10</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>020733</drugauthorizationnumb>
        <drugdosagetext>DOSAGE INFORMATION UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139534-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-016729-10</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>020733</drugauthorizationnumb>
        <drugdosagetext>DOSING INFORMATION UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139535-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-018737-10</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>EUPHORIC MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>022410</drugauthorizationnumb>
        <drugdosagetext>DOSING INFORMATION UNKNOWN / SUBLINGUAL FILM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139536-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-014102-10</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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>020733</drugauthorizationnumb>
        <drugdosagetext>DOSAGE UNKNOWN AT THIS TIME.</drugdosagetext>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139537-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-017424-10</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST-TRAUMATIC STRESS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>022410</drugauthorizationnumb>
        <drugdosagetext>DSOING INFORMATION UNKNOWN; SUBLINGUAL FILM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139538-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-011681-10</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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SPRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBSTANCE ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>020733</drugauthorizationnumb>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>DRUG DEPENDENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139539-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-017561-10</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>020733</drugauthorizationnumb>
        <drugdosagetext>DOSING INFORMATION UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139540-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-018739-10</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY SLEEP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>022410</drugauthorizationnumb>
        <drugdosagetext>DOSAGE INFORMATION UNKNOWN / SUBLINGUAL FILM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139541-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0034001</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>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100116</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139542-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100810</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0656800-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL DRUGS AFFECTING FOETUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STILLBIRTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRISOMY 21</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020945</drugauthorizationnumb>
        <drugdosagetext>200MG DAILY</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021906</drugauthorizationnumb>
        <drugdosagetext>4 TABLETS DAILY</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100513</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARUNAVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1200MG DAILY</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARUNAVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1200MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMTRICITABINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>200MG DAILY</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100323</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RALTEGRAVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>800MG DAILY</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100323</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>300MG DAILY</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100513</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE + ZIDOVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>2 DOSAGE FORMS DAILY</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100514</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139543-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-WATSON-2010-12224</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>7.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>077663</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIPIPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIHYDROCODEINE BITARTRATE INJ</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORETHISTERONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPRANOLOL HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139544-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033613</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>COR PULMONALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081230</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139545-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0034045</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100119</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139546-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-1010USA02869</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>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090708</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139547-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-1012DEU00016</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>39</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020830</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100915</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORMOTEROL FUMARATE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100429</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139548-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-1007USA04045</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>021445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100416</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081117</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139549-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-1012GBR00019</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVANZ</medicinalproduct>
        <drugauthorizationnumb>021337</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101111</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMIPENEM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139550-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-1004USA03755</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>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100219</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139551-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-1011FRA00128</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
        <drugauthorizationnumb>050587</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA ASPIRATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100925</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
        <drugauthorizationnumb>050587</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100929</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100926</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100929</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100926</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFOTAXIME SODIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100922</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFOTAXIME SODIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKACIN SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PNEUMONIA ASPIRATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100925</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKACIN SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100919</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100919</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139552-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0812USA01748</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>93</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTOCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA AT REST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EDENTULOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMBOLISM ARTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILIAC ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED UPPER AIRWAY SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICTURITION URGENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOCTURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC DISORDER WITH AGORAPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULPITIS DENTAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TARSAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139553-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-MERCK-1008USA01425</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 SODIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugauthorizationnumb>020387</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139554-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-1012GBR00014</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF LIBIDO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPECIA</medicinalproduct>
        <drugauthorizationnumb>020788</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ALOPECIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101030</drugenddate>
        <drugtreatmentduration>146</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139555-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-1007FRA00036</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>
      <patientweight>63</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPODYSTROPHY ACQUIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISENTRESS</medicinalproduct>
        <drugauthorizationnumb>022145</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090429</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATAZANAVIR SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100804</drugenddate>
        <drugtreatmentduration>1846</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139556-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1012USA00178</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>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139557-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-1012FRA00006</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACARODERMATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATAZANAVIR SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE AND EMTRICITABINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENTAL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139558-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1008USA00397</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>ABDOMINAL WALL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EDENTULOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KYPHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA CHLAMYDIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOFT TISSUE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THORACIC VERTEBRAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000328</drugenddate>
        <drugtreatmentduration>1006</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000901</drugenddate>
        <drugtreatmentduration>164</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
        <drugtreatmentduration>422</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139559-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-1012GBR00017</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 DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC PH DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139560-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-MERCK-1007DNK00012</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>151</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE ABDOMEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIRAGLUTIDE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100707</drugenddate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN HUMAN, ISOPHANE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100714</drugenddate>
        <drugtreatmentduration>1527</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TELMISARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100707</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139561-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1005USA01517</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>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICOBRACHIAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSITIVITY OF TEETH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVIAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030919</drugenddate>
        <drugtreatmentduration>464</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080301</drugenddate>
        <drugtreatmentduration>1598</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>20020613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030919</drugenddate>
        <drugtreatmentduration>464</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080301</drugenddate>
        <drugtreatmentduration>1598</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080301</drugenddate>
        <drugtreatmentduration>1887</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139562-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-1012GBR00015</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>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139563-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-1008GBR00092</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139564-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1010USA03560</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020830</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139565-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-1012GBR00016</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>135</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN ASPART, BIPHASIC ISOPHANE [INJECTION]</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091010</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCYCLIDINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139566-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-1011GBR00101</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRIDAMOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139567-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-10P-028-0688538-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPRON DEPOT</medicinalproduct>
        <drugbatchnumb>LNC00787</drugbatchnumb>
        <drugauthorizationnumb>020517</drugauthorizationnumb>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100622</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139568-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-10P-087-0685252-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020478</drugauthorizationnumb>
        <drugdosagetext>INDUCTION: 1%, MAINTENANCE: 1.2-1%</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>SEDATIVE THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTIVA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1749.21MCG DAILY/ 0.2-0.6 MCG/MG/MIN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100330</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTIVA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>0.1 MICROGRAM/KILOGRAM/MINUTE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100329</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROHYPNOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100329</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LINTON</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100329</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100329</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TASMOLIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100329</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GENERAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCURONIUM BROMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPOTONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCURONIUM BROMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SHOCK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTONE</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROPIVACAINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>2 MILLILITER/HOUR</drugdosagetext>
        <drugadministrationroute>008</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS</medicinalproduct>
        <drugindication>OPERATIVE HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRESH FROZEN PLASMA</medicinalproduct>
        <drugindication>OPERATIVE HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>20MG DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>1-3-3.5/MCG/KG/MIN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139569-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0688605-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYSTERECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY SLEEP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALPINGO-OOPHORECTOMY BILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPRON</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020011</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLIMARA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139570-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZW-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2007-BP-19493BP</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC INFLAMMATORY RESPONSE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugauthorizationnumb>020933</drugauthorizationnumb>
        <drugdosagetext>360 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE (EPIVIR HBV)</medicinalproduct>
        <drugdosagetext>120 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070516</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>D4T</medicinalproduct>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTRIMOXAZOLE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070820</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPICILLIN</medicinalproduct>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLATE</medicinalproduct>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAFESON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139571-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GENENTECH-304931</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANIBIZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANIBIZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANIBIZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139572-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041004</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-GENENTECH-310568</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139573-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GENENTECH-310625</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>IMMUNE SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139574-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GENENTECH-308272</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ENDOPHTHALMITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITRECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>0.05 ML, 1/MONTH</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>CHOROIDAL NEOVASCULARISATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>0.05 ML, 1/MONTH</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>0.05 ML, 1/MONTH</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139575-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100810</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0689564-00</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>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UROSEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020945</drugauthorizationnumb>
        <drugdosagetext>TAKING AT CONCEPTION</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIRETROVIRAL THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021906</drugauthorizationnumb>
        <drugdosagetext>NOT TAKING AT CONCEPTION, 4TAB/CAP DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIRETROVIRAL THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100513</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARUNAVIR ETHANOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>TAKING AT CONCEPTION</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIRETROVIRAL THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARUNAVIR ETHANOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>TAKING AT CONCEPTION</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMTRICITABINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>TAKING AT CONCEPTION</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIRETROVIRAL THERAPY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100323</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RALTEGRAVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>TAKING AT CONCEPTION</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIRETROVIRAL THERAPY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100323</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>NOT TAKING AT CONCEPTION</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIRETROVIRAL THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100513</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>NOT TAKING AT CONCEPTION, 2TAB/CAP DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIRETROVIRAL THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100514</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139576-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GENENTECH-309589</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100825</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100825</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139577-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006315</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SPLENECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139578-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033857</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 MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070831</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139579-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033771</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</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100415</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139580-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0032590</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</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139581-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7029828</companynumb>
    <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>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139582-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7029830</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>118</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100709</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROPINIROLE</medicinalproduct>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139583-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7029958</companynumb>
    <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>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139584-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ELI_LILLY_AND_COMPANY-CA201009007594</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>APHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100203</drugenddate>
        <drugtreatmentduration>120</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100824</drugenddate>
        <drugtreatmentduration>175</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>5 MG, 2/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>5 MG, 2/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITALUX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIPLEX D</medicinalproduct>
        <drugdosagetext>1500 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>2000 IU, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>1 MG, AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIDURAL</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139585-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201012000841</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>124.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRASUGREL HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugdosagetext>60 MG, ONCE</drugdosagetext>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100625</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRASUGREL HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100626</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100626</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugdosagetext>30 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>25 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugdosagetext>100 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139586-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201010002094</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.12</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRASUGREL HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100708</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139587-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2008-BP-04636BP</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNE RECONSTITUTION SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugauthorizationnumb>020933</drugauthorizationnumb>
        <drugdosagetext>120 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080319</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE (EPIVIR HBV)</medicinalproduct>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080319</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugdosagetext>140 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080319</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTRIMOXAZOLE</medicinalproduct>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAKTARIN ORAL GEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139588-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE201011006317</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>500 MG/M2, DAY 1 EVERY 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>75 MG/M2, DAY 1 EVERY 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>7.5 MG/KG, DAY 1 EVERY 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100909</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139589-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE201011006899</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>500 MG/M2, DAY 1 EVERY 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>75 MG/M2, DAY 1B EVERY 2 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIATION</medicinalproduct>
        <drugdosagetext>2 GY ON DAY 1, THEN DAILY FOR 5 DAYS PER WEEK</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101126</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100909</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
        <drugtreatmentduration>71</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
        <drugtreatmentduration>67</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139590-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-BRISTOL-MYERS SQUIBB COMPANY-15423932</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BARACLUDE</medicinalproduct>
        <drugauthorizationnumb>021797</drugauthorizationnumb>
        <drugindication>HEPATITIS B</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139591-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-15415649</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYSODREN</medicinalproduct>
        <drugauthorizationnumb>016885</drugauthorizationnumb>
        <drugdosagetext>3 TABLETS/DAY THEN 6 TABLETS/DAY AND THEN 9 TABLETS/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ADRENOCORTICAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101105</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ADRENAL INSUFFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100624</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORACILLINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101104</drugenddate>
        <drugtreatmentduration>133</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CACIT D3</medicinalproduct>
        <drugdosagetext>CACIT VITAMINE D3</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100624</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139592-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-15417140</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALVEOLAR PROTEINOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPRYCEL</medicinalproduct>
        <drugauthorizationnumb>021986</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139593-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-10P-062-0688221-00</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>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLACID TABLETS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugdosagetext>10 X 250 MG ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101126</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139594-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-ABBOTT-10P-151-0689281-00</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>COLON ADENOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLIOBLASTOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOCAL CORD ATROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMIFLU</medicinalproduct>
        <drugdosagetext>PATIENT REC'D 1 PACK. UNSURE IF TOOK MED.</drugdosagetext>
        <drugindication>INFLUENZA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139595-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010DE76954</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRANIOTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugindication>CHROMOSOME ANALYSIS ABNORMAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139596-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AMGEN-DEUSP2010004608</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, WEEKLY</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>POLYARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MTX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139597-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AMGEN-FRASP2010005227</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FINGER DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, WEEKLY</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139598-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201012000274</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>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRASUGREL HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325 MG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100413</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>0.075 UNK, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugdosagetext>1 U, AS NEEDED</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>150 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139599-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100929</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-JPNSP2010005436</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ADRENAL INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION STAPHYLOCOCCAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2X/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090511</drugenddate>
        <drugtreatmentduration>186</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2X/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100108</drugenddate>
        <drugtreatmentduration>120</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIMATIL</medicinalproduct>
        <drugdosagetext>100 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>37.5 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugdosagetext>5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081114</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139600-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AMGEN-DEUSP2010005389</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGIOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>50 MG,  PER DAY</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>20 MG, PER DAY</drugdosagetext>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>2400 MG, UNK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139601-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-AMGEN-NLDSP2010005541</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, WEEKLY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100902</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139602-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AMGEN-QUU424898</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER OPHTHALMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</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>20090601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139603-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-JPNSP2010004512</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID FUNCTION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID PTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS TUBERCULOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITH NERVE PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2X/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060330</drugenddate>
        <drugtreatmentduration>74</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2X/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061130</drugenddate>
        <drugtreatmentduration>214</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG 1 TIME PER WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG 1 TIME PER 1 WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100420</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060120</drugenddate>
        <drugtreatmentduration>737</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090216</drugenddate>
        <drugtreatmentduration>343</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100505</drugenddate>
        <drugtreatmentduration>443</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>3 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100505</drugenddate>
        <drugtreatmentduration>2093</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>VARIABLE DOSE 4MG-15 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100520</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100527</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN SODIUM</medicinalproduct>
        <drugdosagetext>180 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100505</drugenddate>
        <drugtreatmentduration>2191</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOBAN</medicinalproduct>
        <drugdosagetext>7.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100505</drugenddate>
        <drugtreatmentduration>286</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIZATIDINE</medicinalproduct>
        <drugdosagetext>300 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100505</drugenddate>
        <drugtreatmentduration>233</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100505</drugenddate>
        <drugtreatmentduration>870</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOSENN</medicinalproduct>
        <drugdosagetext>300 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100505</drugenddate>
        <drugtreatmentduration>1421</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugdosagetext>35 MG 1 TIMES PER 1 WK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100505</drugenddate>
        <drugtreatmentduration>786</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139604-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-AMGEN-NLDSP2010005384</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED UPPER AIRWAY SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2X/WEEK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORMETAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139605-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AMGEN-FRASP2010005543</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE RECALL REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</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>20081101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139606-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2006UW07774</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19330</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>74.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COELIAC DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE HEART DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYNEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>25-100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010719</drugenddate>
        <drugtreatmentduration>701</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>25-200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070814</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
        <drugdosagetext>150-450MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PERSONALITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
        <drugdosagetext>300-450 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070814</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>10 MG AT MORNING AND 20 MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020814</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>10 MG TO 30 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040526</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>0.25-0.5 MG, TWO TIMES A DAY</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020814</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050720</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>STRENGTH-20 MG/20 ML</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugdosagetext>7.5/500 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL XL</medicinalproduct>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030409</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSONISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugdosagetext>0.5-7.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050811</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PEPTIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050811</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PEPTIC ULCER HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050811</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>25-50MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020814</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050707</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080103</drugenddate>
        <drugtreatmentduration>2900</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031106</drugenddate>
        <drugtreatmentduration>450</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESKALITH</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020814</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBIDOPA AND LEVODOPA</medicinalproduct>
        <drugdosagetext>25/100MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugdosagetext>20-40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBYAX</medicinalproduct>
        <drugdosagetext>10 MG TO 30 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040526</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRO-BID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugindication>BLOOD GLUCOSE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
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        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>7139698-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2009-32006</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>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139699-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2009-31270</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>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090625</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139700-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-31513</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE REPLACEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC PACEMAKER INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 62.5 MG US</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 62.5 MG US</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 62.5 MG US</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091022</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139701-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2009-31596</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>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139702-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2009-31597</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>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139703-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100406</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2009-31598</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>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139704-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100601</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-31690</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>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugbatchnumb>BP080P0101/DP022P0102</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100302</drugenddate>
        <drugtreatmentduration>993</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CHANNEL BLOCKERS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139705-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-31616</companynumb>
    <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>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090818</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139706-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2009-31123</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>
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      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7139707-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-30465</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>
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      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>7139708-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2007-30433</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>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
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  <safetyreport>
    <safetyreportid>7139709-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
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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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        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
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    <safetyreportid>7139710-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <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>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
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    <safetyreportid>7139711-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
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      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
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  <safetyreport>
    <safetyreportid>7139712-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
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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>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
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  <safetyreport>
    <safetyreportid>7139713-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2007-30759</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>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>7139714-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
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    <safetyreportid>7140303-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2006-30772</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>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140304-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
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    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2006-31681</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>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140305-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2006-30866</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140306-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2006-30322</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>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140307-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2009BI025227</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>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COOMBS POSITIVE HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IDIOPATHIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090518</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESSALON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUSSIONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140308-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-BIOGENIDEC-2010BI010228</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>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100126</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugindication>MUSCLE SPASMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140309-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BIOGENIDEC-2010BI013482</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETROPLACENTAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100113</drugenddate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140310-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI020534</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>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <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>20081219</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140311-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI026413</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>JOINT DISLOCATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090414</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140312-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BIOGENIDEC-2010BI031019</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>
      <reaction>
        <reactionmeddrapt>CSF TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JC VIRUS TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION VIRAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091022</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>7140313-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI034040</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>AGRAPHIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080521</drugstartdate>
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        <drugenddate>20100420</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUTATHIONE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140314-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
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    <receiptdate>20101124</receiptdate>
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    <companynumb>US-BIOGENIDEC-2010BI038545</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140315-X</safetyreportid>
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    <seriousnesshospitalization>1</seriousnesshospitalization>
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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>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT DISLOCATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090728</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140316-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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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>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
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      <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>20080725</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140317-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI038781</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LACERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100122</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140318-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI039371</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>DIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</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>20091130</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140319-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI040472</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>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140320-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BIOGENIDEC-2010BI040828</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080623</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140321-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041089</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>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETIT MAL EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140322-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BIOGENIDEC-2010BI041402</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALLERGY TO ARTHROPOD STING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090423</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140323-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BIOGENIDEC-2010BI041435</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>JC VIRUS TEST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140324-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041477</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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080828</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140325-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041490</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>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060921</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140326-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-BIOGENIDEC-2010BI041550</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATIC CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101108</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140327-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BIOGENIDEC-2010BI041565</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>APPENDICITIS PERFORATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080102</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140328-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BIOGENIDEC-2010BI041566</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>
      <patientweight>95</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080423</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTINE</medicinalproduct>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFUZOSINE</medicinalproduct>
        <drugindication>BLADDER DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugindication>SCIATICA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100930</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140329-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041650</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>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101004</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140330-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041659</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURED COCCYX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100430</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140331-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-BIOGENIDEC-2010BI041689</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</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>HEMIANOPIA HOMONYMOUS</reactionmeddrapt>
      </reaction>
      <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>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140332-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041731</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>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</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>20100802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100930</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140333-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041734</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>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101017</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140334-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-BIOGENIDEC-2010BI041835</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugbatchnumb>P68096</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101022</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140335-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041895</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNS THIRD DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL ABSCESS</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>20101105</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140336-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041903</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE STRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</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>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIZANIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENAZPRINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOCON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIRTH CONTROL (NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugindication>MUSCLE STRAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140337-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042108</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</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>20080326</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140338-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BIOGENIDEC-2010BI042304</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140339-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005BI009671</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>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE PROLAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32122</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010803</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140340-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BIOGENIDEC-2010BI026337</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>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100521</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-CODAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140341-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI028918</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>CARDIAC ENZYMES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION VENTRICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASTICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL HERPES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32126</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081221</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140342-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI036184</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>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL HERPES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32124</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SUPPLEMENT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOVASCULAR EVENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140343-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042204</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140344-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042238</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>CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140345-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050225</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2005-30345</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>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140346-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI038070</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140347-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2007BI019371</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>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RAYNAUD'S PHENOMENON</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</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>20070810</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140348-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090120</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2009BI002100</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>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100326</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101118</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140349-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI010121</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080313</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140350-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI012131</companynumb>
    <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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA FACIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091023</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140351-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101027</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI019860</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUNBURN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPYRA</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100409</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140352-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI021765</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>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091014</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140353-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI022179</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</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>20100621</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140354-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI024902</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080723</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140355-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI025138</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140356-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI026537</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS POSTURAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION RATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</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>20091105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140357-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI029731</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>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</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>20090916</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140358-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI029854</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>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR VENOUS ACCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100623</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140359-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI030700</companynumb>
    <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>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091231</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140360-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI033540</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>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100824</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140361-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI036187</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG SPECIFIC ANTIBODY PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDERNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100809</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140362-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI036922</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080611</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140363-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI037564</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>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071229</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140364-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI037661</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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080611</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140365-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI039556</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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NARCOLEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080402</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140366-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI040066</companynumb>
    <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>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</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>20080304</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140367-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI040297</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>
      <reaction>
        <reactionmeddrapt>SECONDARY PROGRESSIVE MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091106</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140368-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041191</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 SPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</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>20100420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100923</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS (NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS (NOS)</medicinalproduct>
        <drugindication>CYSTITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140369-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041721</companynumb>
    <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>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090107</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140370-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041904</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>ASTHENIA</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>20070307</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140371-9</safetyreportid>
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    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042003</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>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140372-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042011</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</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>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140373-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042041</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>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100512</drugstartdate>
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    </patient>
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  <safetyreport>
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    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042044</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>
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      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
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      <drug>
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        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
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    </patient>
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  <safetyreport>
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    <transmissiondateformat>102</transmissiondateformat>
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    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042045</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VESSEL PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
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    </patient>
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    <safetyreportid>7140376-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042047</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
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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>20101110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030515</drugstartdate>
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    </patient>
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  <safetyreport>
    <safetyreportid>7140377-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
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    <receiptdate>20101129</receiptdate>
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    <companynumb>US-BIOGENIDEC-2010BI042050</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080709</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140378-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042071</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>COUGH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140379-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042081</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080523</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140380-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042083</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>BONE PAIN</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT BEARING DIFFICULTY</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091112</drugstartdate>
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        <drugenddate>20100701</drugenddate>
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    </patient>
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  <safetyreport>
    <safetyreportid>7140381-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>2</serious>
    <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>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
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      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100927</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100729</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140382-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
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      <reportercountry>UNITED STATES</reportercountry>
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    </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>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
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    <safetyreportid>7140383-5</safetyreportid>
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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>NASOPHARYNGITIS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
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      <drug>
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        <drugindication>MULTIPLE SCLEROSIS</drugindication>
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        <drugstartdate>20080905</drugstartdate>
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    </patient>
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    <sender>
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    <receiver></receiver>
    <patient>
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      <drug>
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        <drugindication>MULTIPLE SCLEROSIS</drugindication>
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        <drugstartdate>20100125</drugstartdate>
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    <receiver></receiver>
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      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</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>20061114</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140387-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042110</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>EYE INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081006</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140388-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042113</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>ANGER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041212</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140389-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042120</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>BODY TEMPERATURE</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>20100107</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140390-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042130</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>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100122</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140391-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042174</companynumb>
    <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>FACIAL SPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140392-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042182</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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL SYMPTOM</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>7140393-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042189</companynumb>
    <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>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050222</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140394-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042194</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070705</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140395-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042198</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>BLOOD TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100510</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140396-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042200</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>ABASIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071031</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031117</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140397-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042205</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED INTEREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140398-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042207</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>INFLUENZA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091116</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140399-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042208</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>INFLUENZA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091012</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140400-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042212</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>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140401-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042214</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101026</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140402-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042215</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>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101026</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140403-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042222</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090824</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140404-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042227</companynumb>
    <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>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081020</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140405-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042234</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED INTEREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140406-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042255</companynumb>
    <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>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101007</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140407-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042260</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140408-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042263</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>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140409-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042266</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090427</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140410-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042269</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>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091123</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140411-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042278</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080709</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140412-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042285</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>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081220</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140413-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042289</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>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080319</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140414-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042316</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090828</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140415-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042337</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</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>20101025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140416-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042342</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101119</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140417-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042351</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>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140418-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042364</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>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070410</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140419-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042366</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>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101122</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140420-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042373</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>FATIGUE</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>20100708</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090316</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140421-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042375</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>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</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>20061108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100811</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140422-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042378</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>DIZZINESS</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>20100527</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140423-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042385</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>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080227</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140424-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042392</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>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>20100128</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140425-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2006-30301</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>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140426-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2005-30656</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>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140427-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2006-31225</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>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140428-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2005-30473</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>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140429-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2006-31026</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>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140430-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2006-30453</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>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140431-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2006-31015</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>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140432-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2006-30346</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>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140433-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <patient>
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        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140926-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2006-29323</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>BOSENTAN TABLET UNKNOWN US MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140927-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>
      <patientweight>110</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugdosagetext>300 MG AM PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020320</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140928-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEPTIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>2.5 MG HS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101108</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140929-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>
      <patientweight>95.2554</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HCL AND ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1 TO 2 TABLETS EVERY 4 HOURS</drugdosagetext>
        <drugindication>TOOTHACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101129</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140930-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM DOUBLE STRENGTH 800/160 SULFAMETHOXAZOLE/TRIMETHOPRIM</medicinalproduct>
        <drugdosagetext>2 DOUBLE STRENGTH TABLETS TWICE DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL SKIN INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101125</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140931-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugbatchnumb>9L49862A</drugbatchnumb>
        <drugdosagetext>TITRATE MOST DAYS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugbatchnumb>9K52684A</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140932-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100823</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-ELI_LILLY_AND_COMPANY-KR201012000843</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</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>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugdosagetext>1250 MG/M2, ON DAY 1 AND 8, EVERY 3 WEEKS</drugdosagetext>
        <drugindication>ADENOCARCINOMA PANCREAS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugdosagetext>950 MG/M2, ON DAY 1 AND 14, EVERY 3 WEEKS</drugdosagetext>
        <drugindication>ADENOCARCINOMA PANCREAS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140933-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100823</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-ELI_LILLY_AND_COMPANY-KR201012000842</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</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>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugdosagetext>1250 MG/M2, ON DAY 1 AND 8, EVERY 3 WEEKS</drugdosagetext>
        <drugindication>ADENOCARCINOMA PANCREAS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugdosagetext>950 MG/M2, ON DAY 1 AND 14, EVERY 3 WEEKS</drugdosagetext>
        <drugindication>ADENOCARCINOMA PANCREAS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140934-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100823</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-ELI_LILLY_AND_COMPANY-KR201012000840</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</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>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugdosagetext>1250 MG/M2, ON DAY 1 AND 8, EVERY 3 WEEKS</drugdosagetext>
        <drugindication>ADENOCARCINOMA PANCREAS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugdosagetext>950 MG/M2, ON DAY 1 AND 14, EVERY 3 WEEKS</drugdosagetext>
        <drugindication>ADENOCARCINOMA PANCREAS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140935-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100823</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-ELI_LILLY_AND_COMPANY-KR201012000632</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugdosagetext>1250 MG/M2, ON DAY 1 AND 8, EVERY 3 WEEKS</drugdosagetext>
        <drugindication>ADENOCARCINOMA PANCREAS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugdosagetext>950 MG/M2, ON DAY 1 AND 14, EVERY 3 WEEKS</drugdosagetext>
        <drugindication>ADENOCARCINOMA PANCREAS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140936-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100823</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-ELI_LILLY_AND_COMPANY-KR201012000844</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</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>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugdosagetext>1250 MG/M2, ON DAY 1 AND 8, EVERY 3 WEEKS</drugdosagetext>
        <drugindication>ADENOCARCINOMA PANCREAS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugdosagetext>950 MG/M2, ON DAY 1 AND 14, EVERY 3 WEEKS</drugdosagetext>
        <drugindication>ADENOCARCINOMA PANCREAS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140937-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100823</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-ELI_LILLY_AND_COMPANY-KR201012000852</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugdosagetext>1250 MG/M2, ON DAY 1 AND 8, EVERY 3 WEEKS</drugdosagetext>
        <drugindication>ADENOCARCINOMA PANCREAS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugdosagetext>950 MG/M2, ON DAY 1 AND 14, EVERY 3 WEEKS</drugdosagetext>
        <drugindication>ADENOCARCINOMA PANCREAS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140938-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>99.7913</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugdosagetext>45MG 1 PER DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140939-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>
      <patientweight>79.3795</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HCL AND ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1 TABLET EVERY 4 HRS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABSCESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101114</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HCL AND ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1 TABLET EVERY 4 HRS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101114</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140940-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.6996</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXERCISE LACK OF</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN WRINKLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090415</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091122</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140941-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.5036</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HCL AND ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140942-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>58.0604</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUNNEL VISION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE + ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>500MG AS NEEDED FOR PAIN DENTAL</drugdosagetext>
        <drugadministrationroute>004</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101124</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140943-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT LABEL ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
        <drugbatchnumb>CONTROL #1000867</drugbatchnumb>
        <drugdosagetext>100 MILLIGRAMS ONCE A YEAR APPLIED TO SKIN YEARS</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140944-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>
      <patientweight>66.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABRAXANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOLOL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINERAL PHACTOR IMMUNE SYSTEM SUPPORT -PROPRIETARY BLEND CONTAINING CH</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNOLIA BARK EXTRACT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140945-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.8435</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>ONE 20 MG TABLET EVERY 12 HOURS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>ONE 20 MG TABLET EVERY 12 HOURS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ROAD TRAFFIC ACCIDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTC ADVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140948-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57.1532</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT SUBSTITUTION ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT TASTE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugbatchnumb>C100980</drugbatchnumb>
        <drugdosagetext>1MG 3 TIMES ADAY</drugdosagetext>
        <drugindication>ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugbatchnumb>C100980</drugbatchnumb>
        <drugdosagetext>1MG 3 TIMES ADAY</drugdosagetext>
        <drugindication>PANIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugbatchnumb>C100981</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140950-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.5036</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT SUBSTITUTION ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAMIPEXOLE DIHYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>ONE Q HS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101130</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140953-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>83.9154</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEFAECATION URGENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT FORMULATION ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT SOLUBILITY ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>TOOK ONLY 2 PER DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>TOOK ONLY 2 PER DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROCEDURAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>TOOK ONLY 2 PER DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPINAL COLUMN STENOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101127</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140956-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>66.6788</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FURUNCLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZARAH 3/0.03 WATSON</medicinalproduct>
        <drugbatchnumb>327131AA</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140958-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT MEASURED POTENCY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT SUBSTITUTION ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugbatchnumb>T176H10B</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugbatchnumb>10H054C</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140959-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT SOLUBILITY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT SUBSTITUTION ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugdosagetext>5 MILLIGRAMS ONCE A DAY MONTHS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140963-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT ODOUR ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROBITUSSIN DM</medicinalproduct>
        <drugbatchnumb>E56508</drugbatchnumb>
        <drugdosagetext>COUGH MEDICINE, 4 OUNCE LIQUID</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140966-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT LABEL ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugbatchnumb>E66890</drugbatchnumb>
        <drugdosagetext>IBUPROFEN TABLETS (200 MG) 200 MILLIGRAMS BOTTLE</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140969-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN CR</medicinalproduct>
        <drugdosagetext>12.5 MILLIGRAMS BOTTLE</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140971-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORAJEL FLOURIDE FREE SAFE TO SWALLOW TOOTHPASTE</medicinalproduct>
        <drugbatchnumb>B0JTU - 32482 - 017000626</drugbatchnumb>
        <drugdosagetext>2 OUNCES OTHER</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140972-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF INJURIOUS BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugbatchnumb>C27101</drugbatchnumb>
        <drugdosagetext>20 TABLETS BOTTLE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101115</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140975-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugdosagetext>500 MILLIGRAMS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101029</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140978-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-TEVA-256675ISR</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugauthorizationnumb>076052</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140979-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-TEVA-257709ISR</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 DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC PH DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALENDRONIC ACID</medicinalproduct>
        <drugauthorizationnumb>075710</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140980-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-TEVA-257719ISR</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>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugauthorizationnumb>074803</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140981-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-TEVA-258165ISR</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugauthorizationnumb>076052</drugauthorizationnumb>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140984-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYRINGE ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugbatchnumb>994BS8</drugbatchnumb>
        <drugdosagetext>42.5 GRAMS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7140987-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-TEVA-258169ISR</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>074656</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OESOPHAGEAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100829</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>074656</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OESOPHAGEAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100829</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100928</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
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    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE INJURIES</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>YASMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141008-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201038302NA</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>MULTIPLE INJURIES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141009-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201038262NA</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>MULTIPLE INJURIES</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>YASMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141010-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201038155NA</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>MULTIPLE INJURIES</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>YASMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141011-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201038140NA</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>MULTIPLE INJURIES</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>YASMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141012-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201041331NA</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>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141017-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE MALFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASMANEX TWISTHALER</medicinalproduct>
        <drugbatchnumb>0JS317</drugbatchnumb>
        <drugdosagetext>USE 1 INHALTION TWICE DAILY</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100905</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141018-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-TEVA-258175ISR</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</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>FLUOROURACIL</medicinalproduct>
        <drugauthorizationnumb>040333</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141019-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-TEVA-258183ISR</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>117</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugauthorizationnumb>075972</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100929</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141020-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-TEVA-258189ISR</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>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugauthorizationnumb>076052</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141021-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-TEVA-258191ISR</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugauthorizationnumb>075719</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>INDOMETACIN</medicinalproduct>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141022-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-TEVA-258233ISR</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>BENIGN INTRACRANIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MESALAZINE</medicinalproduct>
        <drugauthorizationnumb>076841</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFLAMMATORY BOWEL DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141024-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60.54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>542 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>670 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>336 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141025-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBILIRUBINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>1430 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100415</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>70 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100224</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAUNORUBICIN</medicinalproduct>
        <drugdosagetext>150 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100224</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>14 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugdosagetext>34.25 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100923</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100324</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-L-ASPARAGINASE (K-H)</medicinalproduct>
        <drugdosagetext>3750 IU</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>2520 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100323</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THIOGUANINE</medicinalproduct>
        <drugdosagetext>80 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugdosagetext>8 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100317</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141028-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB (RHUMAB VEGF)</medicinalproduct>
        <drugdosagetext>1475 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>243000 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>3490 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugdosagetext>745 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101104</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141030-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20091204206</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOPULMONARY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAMORPH SR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MST</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141031-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20101103899</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>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PALEXIA RETARD</medicinalproduct>
        <drugauthorizationnumb>022304</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141032-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20101201825</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IXPRIM</medicinalproduct>
        <drugauthorizationnumb>021123</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PYOSTACINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANIDIP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141033-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-001674</companynumb>
    <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 INJURY</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>7141034-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-001658</companynumb>
    <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 INJURY</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>7141035-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-001712</companynumb>
    <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 INJURY</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>7141036-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201041420NA</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>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141037-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-001659</companynumb>
    <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 INJURY</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>7141038-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-001432</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141039-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201041480NA</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>DROSPIRENONE + ETHINYLESTRADIOL 20A?G (24+4)</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugindication>ACNE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141040-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-001718</companynumb>
    <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>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080919</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141041-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-001651</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141042-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>HU-BAYER-2010-001441</companynumb>
    <primarysource>
      <reportercountry>HUNGARY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENITAL HAEMORRHAGE</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>20100517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100928</drugenddate>
        <drugtreatmentduration>135</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141043-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-001362</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>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE + ETHINYLESTRADIOL 20A?G (24+4)</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081120</drugenddate>
        <drugtreatmentduration>51</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141044-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-001676</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>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141048-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BICARBONATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID OVERLOAD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHOSPHATAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>701 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>4096 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugdosagetext>15 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>15 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141051-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>630 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>126 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>126 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141053-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-001452</companynumb>
    <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>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141054-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-001535</companynumb>
    <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>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141055-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-001675</companynumb>
    <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>PULMONARY EMBOLISM</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>7141056-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-001654</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141057-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-JNJFOC-20101108763</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAKTHROUGH PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT ADHESION ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>ADB55OO</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141058-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-JNJFOC-20101107898</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>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141059-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-JNJFOC-20100507553</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>43</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEARFULNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>DOSE: 2 MG IN THE AFTERNOON</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>0.5 MG MORNING AND NIGHT</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>1 MG MORNING AND NIGHT</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>1 MG IN THE AFTERNOON</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>DOSE: 1.5 MG MORNING AND NIGHT</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>1 MG MORNING ANG NIGHT</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugdosagetext>DOSE: 0.5 MG OR 1 MG AS AN AD HOC DOSE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020588</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>021444</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMINYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EBIXA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141061-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>2725 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>2231 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100820</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>440 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141063-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>760 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>390 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101122</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141067-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCORMYCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIC SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>60 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MERCAPTOPURINE</medicinalproduct>
        <drugdosagetext>2200 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>55 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugdosagetext>2 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141069-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugdosagetext>40 MG TID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOXIFLOXACIN</medicinalproduct>
        <drugdosagetext>400 MG EVERYDAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141071-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugdosagetext>20 MG EVERYDAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101112</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141072-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>
      <patientweight>66.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101122</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141080-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSIVE THRESHOLD LOWERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTICTAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>50 MG ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141082-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>CZ-JNJFOC-20100905734</companynumb>
    <primarysource>
      <reportercountry>CZECH REPUBLIC</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAPENTADOL</medicinalproduct>
        <drugauthorizationnumb>061345</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100911</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAPENTADOL</medicinalproduct>
        <drugauthorizationnumb>022304</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100911</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVREDOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANISAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALGIFEN</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN SODIUM</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERFALGAN</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVALGIN</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUPHYLLINE</medicinalproduct>
        <drugindication>CHRONIC RESPIRATORY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GUTALAX</medicinalproduct>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141083-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20101200822</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMAL</medicinalproduct>
        <drugauthorizationnumb>020281</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASTICITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPIPERON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTELEPSIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOREM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEZAFIBRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN LYSINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMIZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141084-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101201468</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>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUCYNTA</medicinalproduct>
        <drugauthorizationnumb>022304</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POSTOPERATIVE ANALGESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141085-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>
      <patientweight>55.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>10 MG EVERYDAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101129</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141086-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>40 MG EVERYDAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROTEINURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141087-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>
      <patientweight>81</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugdosagetext>100 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101128</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141090-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-JNJFOC-20101108728</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COELIAC DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MIGRAINE PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141091-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20101200121</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG DISPENSING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMINYL LP</medicinalproduct>
        <drugauthorizationnumb>021615</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMINYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMINYL</medicinalproduct>
        <drugauthorizationnumb>021169</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141092-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-JNJFOC-20101108688</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>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugdosagetext>HALF PATCH</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141093-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>BR-JNJFOC-20101106857</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SYNOVIAL RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GOLIMUMAB</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141094-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101200383</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>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GOLIMUMAB</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GOLIMUMAB</medicinalproduct>
        <drugauthorizationnumb>012729</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTOCORT EC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASACORT</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141095-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>
      <patientweight>119</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXENATIDE</medicinalproduct>
        <drugdosagetext>5 MCG BID SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101129</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141096-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-JNJFOC-20101108690</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</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>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugdosagetext>HALF A PATCH</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141097-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20100900827</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTOID REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CYSTITIS</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141098-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-JNJFOC-20101201267</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EXPIRED DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141099-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-JNJFOC-20101107645</companynumb>
    <primarysource>
      <reportercountry>ITALY</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 HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAELYX</medicinalproduct>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141100-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101128</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20101108349</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101128</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141102-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>72.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141104-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN WARM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDERNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugdosagetext>AZATHIOPRINE 50MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101120</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141106-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE BLISTERING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>ONCE WEEKLY SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100723</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>400 MG ONCE DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100723</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141109-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20MG EVERYDAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20MG EVERYDAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROTEINURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141110-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10060830</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>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141111-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-JNJFOC-20101108722</companynumb>
    <primarysource>
      <reportercountry>NORWAY</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>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141112-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN MIDLINE SHIFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>2 MG EVERYDAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101124</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141113-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
        <drugdosagetext>25 MG TID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101125</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141114-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-22393-10112819</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>ISTODAX</medicinalproduct>
        <drugauthorizationnumb>022393</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141115-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-RANBAXY-2010RR-39799</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIPOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugauthorizationnumb>075944</drugauthorizationnumb>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141116-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2010RR-33093</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOGLOBINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugauthorizationnumb>076285</drugauthorizationnumb>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugtreatmentduration>730</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
        <drugdosagetext>250 MG, QID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSOAS ABSCESS</drugindication>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
        <drugindication>LOWER RESPIRATORY TRACT INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCLOXACILLIN</medicinalproduct>
        <drugdosagetext>500 MG, QID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSOAS ABSCESS</drugindication>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCLOXACILLIN</medicinalproduct>
        <drugdosagetext>500 MG, QID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCLOXACILLIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSOAS ABSCESS</drugindication>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFUROXIME</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSOAS ABSCESS</drugindication>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081209</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141117-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>63.5036</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO REACTION ON PREVIOUS EXPOSURE TO DRUG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STANDARD MITES (I DON'T KNOW THE STRENGTH AND MANUFACTURER.</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101007</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141118-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD</medicinalproduct>
        <drugbatchnumb>LE121470AB</drugbatchnumb>
        <drugdosagetext>GAMMAGARD 20 GRAM IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MYASTHENIA GRAVIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD</medicinalproduct>
        <drugbatchnumb>LE121470AB</drugbatchnumb>
        <drugdosagetext>GAMMAGARD 20 GRAM IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESTINON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141119-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.4514</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIVALO</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141120-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>90.7194</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>A719224C</drugbatchnumb>
        <drugdosagetext>10 MCG TWICE DAILY INJECTION</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141121-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.5234</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTAQ</medicinalproduct>
        <drugdosagetext>1 TABLET EVERY 12 HR. BY MOUTH</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141122-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-RANBAXY-2010RR-39960</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>65.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
        <drugauthorizationnumb>075556</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLEXANE</medicinalproduct>
        <drugdosagetext>0.6 ML, BID</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XIPAMIDE</medicinalproduct>
        <drugdosagetext>10 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080722</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOREM</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBSTRUCTIVE AIRWAYS DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URBASON</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBSTRUCTIVE AIRWAYS DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>22.5 UG, QD</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>OBSTRUCTIVE AIRWAYS DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIANI</medicinalproduct>
        <drugdosagetext>1 DF, BID</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>OBSTRUCTIVE AIRWAYS DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141123-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-RANBAXY-2009RR-20452</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>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugauthorizationnumb>076285</drugauthorizationnumb>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CAROTID ARTERY STENOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081014</drugenddate>
        <drugtreatmentduration>149</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSIDON CIBA-GEIGY</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GENERALISED ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JOHANNISKRAUT-KAPSELN CT</medicinalproduct>
        <drugdosagetext>300 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GENERALISED ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081014</drugenddate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASS 100</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CAROTID ARTERY STENOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081010</drugenddate>
        <drugtreatmentduration>145</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141124-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-RANBAXY-2009RR-22349</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>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISOPROLOL</medicinalproduct>
        <drugdosagetext>5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugauthorizationnumb>078849</drugauthorizationnumb>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FURORESE</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL IMPAIRMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEROTEC</medicinalproduct>
        <drugdosagetext>100 UG, UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FALITHROM ^HEXAL^</medicinalproduct>
        <drugdosagetext>3 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>600 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYNEUROPATHY ALCOHOLIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREGABALIN</medicinalproduct>
        <drugdosagetext>50 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYNEUROPATHY ALCOHOLIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIFROL</medicinalproduct>
        <drugdosagetext>0.18 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYNEUROPATHY ALCOHOLIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>18 UG, QD</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141125-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-RANBAXY-2009RR-20563</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>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugauthorizationnumb>077974</drugauthorizationnumb>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENABETA COMP 10MG/ 25MG</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141126-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RANBAXY-2010US-39935</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>PSEUDOEPHEDRINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>077442</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141127-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RANBAXY-2010US-39138</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>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOTRETINOIN</medicinalproduct>
        <drugbatchnumb>NDC#10631058531</drugbatchnumb>
        <drugauthorizationnumb>076041</drugauthorizationnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141128-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TYCO HEALTHCARE/MALLINCKRODT-T201002363</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 TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXALGO</medicinalproduct>
        <drugauthorizationnumb>021217</drugauthorizationnumb>
        <drugdosagetext>15 MG SR X 1</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
        <drugdosagetext>10/325 X 2</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
        <drugdosagetext>ONE PILL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141129-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>77.1115</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR DEMENTIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141130-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5036</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE BURN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DESONIDE</medicinalproduct>
        <drugbatchnumb>KT0074</drugbatchnumb>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugindication>DERMATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141131-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>68.0396</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugdosagetext>2 TABLETS 2 TIMES A DAY</drugdosagetext>
        <drugindication>HEART RATE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100222</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141132-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10112815</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53.572</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAILURE TO THRIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141133-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090903</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-CELGENEUS-056-21880-10081769</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL CONDITION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081231</drugenddate>
        <drugtreatmentduration>342</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALACYCLOVIR HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEDERFOLINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RULID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141134-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SHIRE-SPV1-2010-02110</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTHANUM CARBONATE</medicinalproduct>
        <drugdosagetext>750 MG, OTHER, TOTAL DAILY DOSE 9IMMEDIATELY AFTER MEALS)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091219</drugenddate>
        <drugtreatmentduration>227</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugdosagetext>12 DF, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugdosagetext>9 DF, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090909</drugenddate>
        <drugtreatmentduration>84</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugdosagetext>3 DF, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091021</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugdosagetext>6 DF, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091219</drugenddate>
        <drugtreatmentduration>59</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DORNER</medicinalproduct>
        <drugdosagetext>60 ?G, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPALMON</medicinalproduct>
        <drugdosagetext>15 ?G, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>1.25 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
        <drugdosagetext>15 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugdosagetext>300 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPS</medicinalproduct>
        <drugdosagetext>200 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugdosagetext>50 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUVELA N</medicinalproduct>
        <drugdosagetext>600 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141135-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2010R1-39406</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>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugauthorizationnumb>076327</drugauthorizationnumb>
        <drugdosagetext>50 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugbatchnumb>35538A</drugbatchnumb>
        <drugdosagetext>100 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugbatchnumb>35528</drugbatchnumb>
        <drugdosagetext>50 MG, BID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100812</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INFLUENZA VIRUS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOFRADEX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHOLESTEATOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GENERALISED NON-CONVULSIVE EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100707</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141137-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1115</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE DRYNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugbatchnumb>060969A</drugbatchnumb>
        <drugdosagetext>SPRAY NOSTRI L TWICE A DAY</drugdosagetext>
        <drugindication>NASAL CONGESTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101026</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugbatchnumb>060969A</drugbatchnumb>
        <drugdosagetext>SPRAY NOSTRI L TWICE A DAY</drugdosagetext>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101026</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141139-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87.5442</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugdosagetext>156 MG 4 IN ONE MONTH INJECTION</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugbatchnumb>BF530001</drugbatchnumb>
        <drugdosagetext>2 TABLETS DAILY MOUTH (SEVERAL YEARS)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141142-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SHIRE-SPV1-2010-02111</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>ABDOMINAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULAR PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSRENOL</medicinalproduct>
        <drugauthorizationnumb>021468</drugauthorizationnumb>
        <drugdosagetext>500 MG, OTHER, TOTAL DAILY DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100930</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141143-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-RANBAXY-2010R1-39929</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNE RECONSTITUTION SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRA-UTERINE DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXOPLASMOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugauthorizationnumb>077327</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOPINAVIR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141144-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TYCO HEALTHCARE/MALLINCKRODT-T201002175</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>VOMITING PROJECTILE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXALGO</medicinalproduct>
        <drugauthorizationnumb>021217</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141145-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TYCO HEALTHCARE/MALLINCKRODT-T201002254</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXALGO</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021217</drugauthorizationnumb>
        <drugdosagetext>8 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141146-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TYCO HEALTHCARE/MALLINCKRODT-T201002264</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXALGO</medicinalproduct>
        <drugauthorizationnumb>021217</drugauthorizationnumb>
        <drugdosagetext>8 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141147-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200941142NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugbatchnumb>61271A</drugbatchnumb>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061125</drugenddate>
        <drugtreatmentduration>578</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141148-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200941142NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugbatchnumb>61271A</drugbatchnumb>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061125</drugenddate>
        <drugtreatmentduration>578</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141150-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.1324</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>2 PER DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141153-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>1/2 OF 50 2 X DAY</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101024</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141155-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10113059</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HODGKIN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141156-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>64.8644</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERBINAFINE HCL</medicinalproduct>
        <drugdosagetext>1 TAB - 30 DAYS</drugdosagetext>
        <drugindication>RASH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101106</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141158-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>101.6057</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOVENOUS MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENIGN INTRACRANIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY REOCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCRATCH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG 1 TABLET DAILY ORALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100412</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG 1 TABLET DAILY ORALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STENT PLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100412</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIAZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMORIN VAGINAL CREAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZERTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRSLAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141161-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>14.0615</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>001900</drugbatchnumb>
        <drugdosagetext>150MG 2-MORN/EVE</drugdosagetext>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141164-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.7716</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugdosagetext>120MG DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101022</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141169-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-CELGENEUS-087-21880-10101247</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROGENIC BLADDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA STAPHYLOCOCCAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101007</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101002</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101007</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAI-KENCHU-TO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTON PUMP INHIBITOR</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141170-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC.-2010-RO-01537RO</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>077900</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141172-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>50.8029</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INADEQUATE ANALGESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>40MG BID P.0</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPINA BIFIDA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>40MG BID P.0</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101105</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141174-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.1834</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>40 MG 4 X DAILY (PO)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FRACTURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141176-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>58.9676</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugdosagetext>INTERVENOUS YEARLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE DENSITY DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141178-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.0187</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INADEQUATE ANALGESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT FORMULATION ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>80 MG OP TWICE A DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>80 MG OP TWICE A DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101120</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141180-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>69.8539</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN AND CLAVULANATE POTASSIUM</medicinalproduct>
        <drugdosagetext>1 TABLET TWICE A DAY</drugdosagetext>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN AND CLAVULANATE POTASSIUM</medicinalproduct>
        <drugdosagetext>1 TABLET TWICE A DAY</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN AND CLAVULANATE POTASSIUM</medicinalproduct>
        <drugdosagetext>1 TABLET TWICE A DAY</drugdosagetext>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091213</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141182-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-JPNCT2010006317</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARONYCHIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANITUMUMAB</medicinalproduct>
        <drugdosagetext>6 MG/KG, Q2WK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINOMYCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>040</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM LEVOFOLINATE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM LEVOFOLINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHISTAMINES</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTAMIN KOWA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXART</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141183-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-000333</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>71062B</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141184-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-000003</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>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLUGGISHNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101026</drugenddate>
        <drugtreatmentduration>164</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugindication>VERTIGO</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141186-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>99.7913</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugdosagetext>100MG ONCE A DAY (LAST FIVE YEARS)</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141188-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>65.7716</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugdosagetext>4 WEEKS 100MG 4 WEEKS</drugdosagetext>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENZTROPINE 0.5MG</medicinalproduct>
        <drugbatchnumb>019890414901</drugbatchnumb>
        <drugdosagetext>1 TABLET TWICE A DAY 2XADAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001013</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141189-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>88.4514</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
        <drugdosagetext>180 3 TIMES PER DAY</drugdosagetext>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101129</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141190-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>
      <patientweight>99.7913</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HCL AND ACETAMINOPHEN</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141191-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20101201887</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTERED AT INAPPROPRIATE SITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUROTEP MT</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141192-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20101201775</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>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOTOMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZALIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TASMOLIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSONISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODIOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC FUNCTION ABNORMAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141193-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20100704843</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>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SURGERY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020635</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ABDOMINAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BACTERIAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERTAPENEM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OCTREOTIDE ACETATE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN R</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLORTHIAZID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141194-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20101104845</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>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugdosagetext>TWO 1 MG TABLETS, TWICE A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALOMONTH</medicinalproduct>
        <drugauthorizationnumb>018701</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIPERIDEN HYDROCHLORIDE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIPERIDEN HYDROCHLORIDE TAB</medicinalproduct>
        <drugdosagetext>TWO 1 MG TABLETS, TWICE A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>YOKUKAN-SAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141195-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>88.4514</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ CODEINE</medicinalproduct>
        <drugdosagetext>1 PILL TOOK ONLY ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOOTH EXTRACTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141196-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>
      <patientweight>122.9248</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYVANSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141197-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>204.1187</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC ISCHAEMIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>1 DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101129</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141198-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>81.6475</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HCL AND ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>40 1 OR 2 EVERY 4-6 H</drugdosagetext>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HCL AND ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>40 1 OR 2 EVERY 4-6 H</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101129</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141200-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>65.7716</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugbatchnumb>1090401</drugbatchnumb>
        <drugdosagetext>1 PILL ONCE A DAY</drugdosagetext>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141201-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101200336</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>112.04</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugauthorizationnumb>021121</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugauthorizationnumb>021999</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141202-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-JNJFOC-20101106120</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF INJURIOUS BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SELF INJURIOUS BEHAVIOUR</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141203-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101200675</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>47.63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INADEQUATE ANALGESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION DURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BONE PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
        <drugbatchnumb>0920044</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugdosagetext>NDC: 0781-7242-55</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BONE PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAKTHROUGH PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION NOS</medicinalproduct>
        <drugdosagetext>ONCE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141204-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101200654</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>120.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTERED AT INAPPROPRIATE SITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
        <drugbatchnumb>0920044</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugdosagetext>NDC: 0781-7242-55</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141205-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20100805162</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>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SKIN INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141206-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20100806486</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>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STEROIDS NOS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141207-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101004631</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>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULNAR TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC SINUSITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141208-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-JNJFOC-20101200132</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141209-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20100903181</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>DRUG ADMINISTERED AT INAPPROPRIATE SITE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
        <drugbatchnumb>0903060</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAKTHROUGH PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141210-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101200801</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>DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT ADHESION ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPOROMANDIBULAR JOINT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHIPLASH INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
        <drugbatchnumb>1000862</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugdosagetext>NDC: 0781-7244-55</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugbatchnumb>30877</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFLAMMATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRATEST</medicinalproduct>
        <drugdosagetext>1/2 STRENGTH DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
        <drugdosagetext>4 TIMES DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE RELAXANT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141211-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101200805</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0919337</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0919337</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>5X DAY/30MG/TAB/ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAKTHROUGH PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141212-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20090100574</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL FUNCTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIFE EXPECTANCY SHORTENED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST-TRAUMATIC STRESS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL CORD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOZINAN</medicinalproduct>
        <drugindication>RELAXATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMIPRAMINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141213-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20101201213</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugauthorizationnumb>021121</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141215-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>60.3284</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPRON DEPOT</medicinalproduct>
        <drugdosagetext>MONTHLY IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPRON DEPOT</medicinalproduct>
        <drugdosagetext>MONTHLY IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>OESTROGEN RECEPTOR ASSAY POSITIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STRATTERRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLBIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141217-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>136.0791</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
        <drugdosagetext>1 TO 2 UP TO EVERY 4HOURS (AT LEAST 2 YEARS)</drugdosagetext>
        <drugindication>GOUT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141219-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORADIL</medicinalproduct>
        <drugbatchnumb>S0257A</drugbatchnumb>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141221-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>14.7</patientweight>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-ASPARAGINASE UNKNOWN UNKNOWN</medicinalproduct>
        <drugdosagetext>1600 UNITS ONCE IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141223-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>72.5755</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CORTICOTROPHIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CORTISOL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CUSHINGOID</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD CRAVING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENALOG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141224-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101200756</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92.99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTERED AT INAPPROPRIATE SITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT ADHESION ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>1004025P1</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>1004025P1</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141225-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101200684</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientweight>81.65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HELICOBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugdosagetext>100 UG/HR+25 UG/HR</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141226-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101200788</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141227-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20100500719</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>MENISCUS LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENOSYNOVITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141228-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101201345</companynumb>
    <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>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141230-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20100804155</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>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CYSTITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141231-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101201194</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.33</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
        <drugbatchnumb>0919336</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>COMPLEX REGIONAL PAIN SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
        <drugbatchnumb>0919336</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>INTERVERTEBRAL DISC DEGENERATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141232-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101202170</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>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXIL</medicinalproduct>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugdosagetext>7 TO 8 CYCLES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141233-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20101201228</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>4</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>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141234-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101104009</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
        <drugbatchnumb>0920407</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>NECK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
        <drugbatchnumb>0920407</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141235-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20100500644</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>CD4 LYMPHOCYTES DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHALAMO-PITUITARY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SECONDARY ADRENOCORTICAL INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARUNAVIR</medicinalproduct>
        <drugauthorizationnumb>021976</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETRAVIRINE</medicinalproduct>
        <drugauthorizationnumb>022187</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETIMIBE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS NOS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-TRIMOXAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141236-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20081204695</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>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRIZOLE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BRONCHOPULMONARY ASPERGILLOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRIZOLE</medicinalproduct>
        <drugauthorizationnumb>020966</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRIZOLE</medicinalproduct>
        <drugauthorizationnumb>020083</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141237-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20101003951</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 HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FINIBAX</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PNEUMONIA ASPIRATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FINIBAX</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FINIBAX</medicinalproduct>
        <drugauthorizationnumb>022106</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOL-MELCORT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACUTE RESPIRATORY DISTRESS SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOSTAGINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RYTHMODAN P</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VEEN-D</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>FLUID REPLACEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TPN ELECTROLYTES IN PLASTIC CONTAINER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>FLUID REPLACEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTHENOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MECHANICAL ILEUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MECHANICAL ILEUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141239-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>
      <patientweight>59</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIROXICAM</medicinalproduct>
        <drugdosagetext>20 MG EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100130</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141240-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>
      <patientweight>135</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOKING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>40 MG EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141242-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.1834</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugdosagetext>1 TABLET DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLADDER CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090515</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141243-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0688227-00</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>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>82418LJ40</drugbatchnumb>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141244-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-15407703</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>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA ACIDOTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugauthorizationnumb>020757</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOPLUS MET</medicinalproduct>
        <drugdosagetext>1DF=15MG/850MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANDEMRIX</medicinalproduct>
        <drugbatchnumb>A81CA103A</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>H1N1 INFLUENZA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BI-PROFENID</medicinalproduct>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVIGARD PAC (COPACKAGED)</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLIAN</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XATRAL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091122</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141245-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-15415573</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADRENAL INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELANODERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAPULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYSODREN</medicinalproduct>
        <drugauthorizationnumb>016885</drugauthorizationnumb>
        <drugdosagetext>3 TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ADRENOCORTICAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101105</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ADRENAL INSUFFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100624</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORACILLINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101104</drugenddate>
        <drugtreatmentduration>133</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CACIT D3</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100624</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141247-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20100505185</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY BYPASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>Q 7</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141248-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101200484</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>ORMKA82902</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>ORMKA82902</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141250-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20100510083</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>ORMKA80706</drugbatchnumb>
        <drugdosagetext>THERAPY DURATION ^TO PRESENT^ AND ALSO AS ^UNKNOWN^ IF RE-INTRODUCED</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVO ALENDRONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>DOSE REPORTED AS: ^50 MG 1.5 MG BID^</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESALAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141251-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20100206967</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENITAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM + D3</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugindication>ANAL FISTULA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141252-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20100303006</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>REMICADE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM W/VITAMIN D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141253-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-JNJFOC-20101007036</companynumb>
    <primarysource>
      <reportercountry>DENMARK</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>BREAST PROSTHESIS IMPLANTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141254-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010163912</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELECOX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>200MG, UNKNOWN/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101120</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
        <drugdosagetext>500 MG, UNKNOWNLD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ENTEROCOLITIS INFECTIOUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101120</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141255-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010121819</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIC PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SALAZOPYRIN</medicinalproduct>
        <drugauthorizationnumb>007073</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MESALAZINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141256-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2010156010</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL DRUG INTAKE BY CHILD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHINADVIL</medicinalproduct>
        <drugauthorizationnumb>019771</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ACCIDENTAL EXPOSURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141257-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-PFIZER INC-2010163779</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</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>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugdosagetext>2.5 MG, 25 MGW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081203</drugenddate>
        <drugtreatmentduration>296</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SALAZOPYRIN</medicinalproduct>
        <drugauthorizationnumb>007073</drugauthorizationnumb>
        <drugdosagetext>500 MG, 3 GMD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081203</drugenddate>
        <drugtreatmentduration>296</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRONAXEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141258-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-PFIZER INC-2010155576</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141259-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7194</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HCL AND ACETAMINOPHEN</medicinalproduct>
        <drugbatchnumb>58CL</drugbatchnumb>
        <drugdosagetext>100-650- 1 TABLET 3 TIMES DAYLY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101015</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141260-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-PFIZER INC-2010155560</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141261-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2010156012</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL DRUG INTAKE BY CHILD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHINADVIL</medicinalproduct>
        <drugauthorizationnumb>019771</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACCIDENTAL EXPOSURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141262-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010132850</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>
      <patientweight>56</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FACIAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101014</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANALDINE</medicinalproduct>
        <drugdosagetext>UNK 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPROMEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIVADIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRANDOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141263-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-15416365</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>OESOPHAGEAL ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141264-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15418270</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>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TORTICOLLIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>15MG DOSE INCREASED TO 20MG DURATION:1.5- 2 MONTHS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141265-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KW-BRISTOL-MYERS SQUIBB COMPANY-15426117</companynumb>
    <primarysource>
      <reportercountry>KUWAIT</reportercountry>
      <qualification>3</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>IFOSFAMIDE</medicinalproduct>
        <drugauthorizationnumb>019763</drugauthorizationnumb>
        <drugindication>BONE SARCOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141266-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BRISTOL-MYERS SQUIBB COMPANY-15418130</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugauthorizationnumb>009218</drugauthorizationnumb>
        <drugdosagetext>1DF:2 POSOLOGIC UNIT INTERRUPTED ON 01FEB2010</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugdosagetext>1DF: 1 POSOLOGIC UNIT INTERRUPTED ON 01FEB2010</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVISACOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIBOMET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141267-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-CELGENEUS-129-C5013-10113167</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>103</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PERIPHERAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CC-5013\PLACEBO</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CC-5013\PLACEBO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101130</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141268-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15285737</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>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>DISCONTINUED ON 27AUG10</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100804</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>1DF= 6 AUC; TAKEN OFF THE PROTOCOL ON 27AUG10</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>TAKEN OFF THE PROTOCOL ON 27AUG10</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100722</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100708</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100722</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141269-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-15321409</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>
      <patientweight>52</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>RECENT:15SEP10 ON DAY 1 OF CYCLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100817</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>RECENT:29SEP10 2ND TREATMENT CYCLE IN TOTAL ON DAY 1-15</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100817</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141270-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-BRISTOL-MYERS SQUIBB COMPANY-15361512</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</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101006</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED DISODIUM</medicinalproduct>
        <drugdosagetext>VIAL;</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101006</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101006</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYNORM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPAVAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXOFEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOLLIPECT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXASCAND</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELOKEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TROMBYL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIMOX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTROPROPOXYPHENE NAPSILATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETHANOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLYSORBATE 20</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPHEDRINE HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141271-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-000306</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>DEVICE DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>82225B</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 A?G, CONTINUOUS</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101117</drugenddate>
        <drugtreatmentduration>783</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141274-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-BAYER-2010-001877</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100714</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141275-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-CELGENEUS-161-21880-10120009</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101129</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101129</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141277-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-CELGENEUS-129-21880-10113193</companynumb>
    <primarysource>
      <reportercountry>POLAND</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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141278-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC.-2010-RO-01451RO</companynumb>
    <primarysource>
      <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>NARATRIPTAN</medicinalproduct>
        <drugbatchnumb>060203A</drugbatchnumb>
        <drugauthorizationnumb>090381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXCEDRIN (MIGRAINE)</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141279-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>110.6777</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT CONTAMINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141282-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>
      <patientweight>8.3915</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL DRYNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYLAND'S TEETHING TABLETS HYLAND'S</medicinalproduct>
        <drugdosagetext>2-3 TABLETS 4 TIMES A DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TEETHING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101129</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141285-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10120269</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>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070912</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141286-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10112044</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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141287-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10120373</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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141291-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.0396</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO TRI-CYCLEN LO</medicinalproduct>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100729</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141293-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>85.7298</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>2.5 1 TIME DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101126</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141296-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>53.0709</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HCL AND ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1 TABLET TWICE A DAY DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101130</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141297-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010007284</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MALIGNANT MELANOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>320 UNK, UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141298-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KW-BRISTOL-MYERS SQUIBB COMPANY-15411044</companynumb>
    <primarysource>
      <reportercountry>KUWAIT</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>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>018057</drugauthorizationnumb>
        <drugdosagetext>1DF=720MG/M SUP(2)</drugdosagetext>
        <drugindication>BONE SARCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugdosagetext>1 DF = 450MG/M SUP(2)</drugdosagetext>
        <drugindication>BONE SARCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>086358</drugauthorizationnumb>
        <drugdosagetext>1 DF = 144MG/M SUP(2)</drugdosagetext>
        <drugindication>BONE SARCOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141299-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-50794-10111691</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>VIDAZA</medicinalproduct>
        <drugauthorizationnumb>050794</drugauthorizationnumb>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANSFUSION SDP</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141301-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>
      <patientweight>76.87</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugdosagetext>75MG TWICE DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101130</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141303-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>
      <patientweight>97.5234</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMYOTROPHIC LATERAL SCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40MG 1 PILL EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100205</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141305-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87.9978</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugdosagetext>IV CONTINUOUS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101003</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141306-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10120252</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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141307-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10120278</companynumb>
    <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>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141308-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>114 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>205 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141313-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0688550-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERAMMONAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERNATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugdosagetext>UP TO 10 GM</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141314-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>31.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 1 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONCASPAR</medicinalproduct>
        <drugdosagetext>2700 IU</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>143 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>70 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>15 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugdosagetext>6.4 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141315-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-CELGENEUS-151-50794-09091831</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDAZA</medicinalproduct>
        <drugauthorizationnumb>050794</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090904</drugenddate>
        <drugtreatmentduration>60</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPAMIDE</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090820</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIPERACILLINE</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090918</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090918</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TREONAM</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090918</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090820</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090910</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141320-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.6996</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>1 DAILY EVERY DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141321-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLOSTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMALE GENITAL TRACT FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URETHRAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>282 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>81 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101004</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141322-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101201612</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141323-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10113090</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>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141324-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10120149</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>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141327-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>123.18</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugdosagetext>1000 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141331-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>1500MG BID IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOMYELITIS</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TORADOL</medicinalproduct>
        <drugdosagetext>30GM Q6H IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141333-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-232723J09USA</companynumb>
    <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 MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020626</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141334-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC.-2010-RO-01406RO</companynumb>
    <primarysource>
      <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>IMMUNE SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL MUCOSAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugbatchnumb>059416A</drugbatchnumb>
        <drugauthorizationnumb>076504</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>MULTIPLE ALLERGIES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141335-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100927</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-CELGENEUS-107-20785-10092675</companynumb>
    <primarysource>
      <reportercountry>MEXICO</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>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugauthorizationnumb>020785</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141336-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RANBAXY-2010US-39964</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PSEUDOEPHEDRINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>077442</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141337-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RANBAXY-2010US-39449</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HAEMODYNAMIC INSTABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugauthorizationnumb>019152</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHANOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL AND ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141338-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA76109</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>ALISKIREN ALI+</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETA BLOCKING AGENTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANGIOTENSIN II ANTAGONISTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141339-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US75908</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM T WAVE INVERSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TASIGNA</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>150 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101106</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHERATUSSIN</medicinalproduct>
        <drugdosagetext>10 ML, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND HYDROCODONE BITARTRATE</medicinalproduct>
        <drugdosagetext>1 DF, BID</drugdosagetext>
        <drugindication>TENDONITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>1 DF, BID</drugdosagetext>
        <drugindication>NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEKTURNA</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYUREA</medicinalproduct>
        <drugdosagetext>2 DF, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141340-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US14616</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>112.29</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TASIGNA</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>200 MG, 2 TAB Q12H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM CD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORUVAIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141341-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP38630</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOCYTE COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SERUM FERRITIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ICL670A ICL+DISTAB</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>875 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081119</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ICL670A ICL+DISTAB</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1000MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081126</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ICL670A ICL+DISTAB</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>750MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081203</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ICL670A ICL+DISTAB</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>875MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090107</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ICL670A ICL+DISTAB</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1000MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090114</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ICL670A ICL+DISTAB</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>750MG  DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090128</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ICL670A ICL+DISTAB</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>875MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090624</drugenddate>
        <drugtreatmentduration>147</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>15MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090806</drugenddate>
        <drugtreatmentduration>310</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYNASE</medicinalproduct>
        <drugdosagetext>40MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090724</drugenddate>
        <drugtreatmentduration>297</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugdosagetext>200MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090709</drugenddate>
        <drugtreatmentduration>282</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLAKAY</medicinalproduct>
        <drugdosagetext>15MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081126</drugenddate>
        <drugtreatmentduration>57</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
        <drugdosagetext>300MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090622</drugenddate>
        <drugtreatmentduration>83</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIRSTCIN</medicinalproduct>
        <drugdosagetext>2G</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090726</drugenddate>
        <drugtreatmentduration>39</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>0.5G</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090729</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugdosagetext>600MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090731</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HCL</medicinalproduct>
        <drugdosagetext>300MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090728</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugdosagetext>160MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090805</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS, CONCENTRATED</medicinalproduct>
        <drugdosagetext>2 UNITS EVERY 3-4 DAYS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS, CONCENTRATED</medicinalproduct>
        <drugdosagetext>2 UNITS EVERY 2 WEEKS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090610</drugenddate>
        <drugtreatmentduration>71</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS, CONCENTRATED</medicinalproduct>
        <drugdosagetext>2 UNITS EVERY 2-5 DAYS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090804</drugenddate>
        <drugtreatmentduration>48</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141342-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010DE17886</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMYOTROPHIC LATERAL SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE ATROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STI571/CGP57148B T35717+CAPS</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON ALFA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080311</drugenddate>
        <drugtreatmentduration>1090</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASS ^CT-ARZNEIMITTEL^</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141343-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010IN82345</companynumb>
    <primarysource>
      <reportercountry>INDIA</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>FEMARA</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugdosagetext>ONE TABLET PER DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141344-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007US21744</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE MARROW TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141345-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR82072</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>ACLASTA</medicinalproduct>
        <drugbatchnumb>UNK.</drugbatchnumb>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141346-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010IT17806</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL TUBE INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>10 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALIGNANT HEPATOBILIARY NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091025</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>NO TREATMENT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091030</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>10 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091031</drugenddate>
        <drugtreatmentduration>1</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>20091101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091102</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>NO TREATMENT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091105</drugenddate>
        <drugtreatmentduration>3</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>20091106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091108</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141347-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA82268</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091005</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141348-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010KR04164</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>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KLEBSIELLA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMULECT</medicinalproduct>
        <drugdosagetext>20 MG, DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMULECT</medicinalproduct>
        <drugdosagetext>20 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091218</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ASCITES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100114</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ASCITES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091230</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100103</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141349-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-GENZYME-THYM-1001918</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS ASSOCIATED LYMPHOPROLIFERATIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA VIRAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>12.5 MG/KG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE</medicinalproduct>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORFLOXACIN</medicinalproduct>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR SODIUM</medicinalproduct>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GANCICLOVIR</medicinalproduct>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIFUNGALS</medicinalproduct>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141352-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HELICOBACTER GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>QDAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY EMBOLISM</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141355-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugdosagetext>50MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE PROPHYLAXIS</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141357-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57.1532</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugdosagetext>INJECTION EVERY 3 WEEKS SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>UTERINE LEIOMYOSARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101123</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141359-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL</medicinalproduct>
        <drugdosagetext>QDAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141360-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RO-ABBOTT-10P-135-0623849-00</companynumb>
    <primarysource>
      <reportercountry>ROMANIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS B</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>300 MG DAILY</drugdosagetext>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1 GRAM DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091218</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>2 GRAM DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAGOSA</medicinalproduct>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141361-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52.3905</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141362-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80.2867</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMRUBICIN 40MG/M2</medicinalproduct>
        <drugbatchnumb>10F0071</drugbatchnumb>
        <drugdosagetext>70 MG, DAYS 1-3, IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PALONOSETRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORMAL SALINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141363-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CENTRUM MULTIVITAMIN/MULTI  MINERAL SUPPLEMENT LIQUID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141364-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>95.2554</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARTILAGE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOPID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141365-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugbatchnumb>CK10028</drugbatchnumb>
        <drugdosagetext>500MG</drugdosagetext>
        <drugindication>TOOTH INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101105</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141366-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</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>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORAL CLOFARABINE, 1 MG, GENZYME CORP.</medicinalproduct>
        <drugdosagetext>1MG X7D, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM W/ VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMOVATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEFLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141367-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US69664</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1250 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100924</drugenddate>
        <drugtreatmentduration>400</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141368-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US81856</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>35.374</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERYTHROLEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141369-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP64016</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>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FUNCTION TEST DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RALES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURFACTANT PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>80 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
        <drugtreatmentduration>4334</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLETAL</medicinalproduct>
        <drugdosagetext>50 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
        <drugtreatmentduration>2066</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
        <drugtreatmentduration>2066</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugdosagetext>0.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUP-4</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141370-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US77929</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1000 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141371-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010NL82366</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOBI</medicinalproduct>
        <drugauthorizationnumb>050753</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141372-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US82474</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>2000 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1000 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIDAZA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141373-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US82473</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>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>3000 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141374-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR201012000936</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFERALGAN CODEINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141375-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011007250</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.84</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PEMPHIGOID</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugdosagetext>1 D/F, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141376-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-ELI_LILLY_AND_COMPANY-PL201011007704</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>48</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NECITUMUMAB (11F8) (LY3012211)</medicinalproduct>
        <drugdosagetext>800 MG, OTHER</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugdosagetext>1912 MG, OTHER</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>114 MG, UNK</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141377-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201010005475</companynumb>
    <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 INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC FOOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugdosagetext>75 U, 2/D</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141378-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011007297</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>UNK, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141379-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011002197</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.84</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>A677501A</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100707</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>500 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugdosagetext>30 MG/KG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BURNING SENSATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugdosagetext>5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugdosagetext>37.5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>25 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>2000 U, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN D DECREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141380-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE201011004209</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HCL</medicinalproduct>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugdosagetext>2787 MG, UNK</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101026</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HCL</medicinalproduct>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>167 MG, UNK</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101019</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMIZOL /06276702/</medicinalproduct>
        <drugdosagetext>160 D/F, UNK</drugdosagetext>
        <drugindication>TUMOUR PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMETEROL</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLDIGOXIN</medicinalproduct>
        <drugindication>TACHYARRHYTHMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugdosagetext>47.5 MG, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
        <drugindication>TUMOUR PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLCYSTEINE</medicinalproduct>
        <drugdosagetext>600 MG, UNK</drugdosagetext>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRAT</medicinalproduct>
        <drugdosagetext>145 MG, UNK</drugdosagetext>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TINZAPARIN SODIUM</medicinalproduct>
        <drugdosagetext>3500 D/F, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMID</medicinalproduct>
        <drugdosagetext>80 MG, UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100721</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSE</medicinalproduct>
        <drugdosagetext>1000 ML, UNK</drugdosagetext>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101108</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FLUID RETENTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101109</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIHYDROCODEINE</medicinalproduct>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101109</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141381-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PRIAPISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugdosagetext>2 TIMES MO</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141382-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-AVENTIS-2010SA073102</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141383-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOFARABINE 1MG/ML - GENZYME</medicinalproduct>
        <drugbatchnumb>10-000423</drugbatchnumb>
        <drugdosagetext>55MG QD IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>..</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141384-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>45.6319</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPEN WOUND</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>2 NIGHT QD@HS MOUTH</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101014</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141385-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>90.7194</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORRECTIVE LENS USER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT CREPITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugdosagetext>500 MG ONE A DAY</drugdosagetext>
        <drugindication>CHEST DISCOMFORT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>.</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141386-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>41.368</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOLFOX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141387-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.1115</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100607</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141388-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>
      <patientweight>92.5338</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LENALIDOMIDE</medicinalproduct>
        <drugdosagetext>25MG PO DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HODGKIN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141389-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-AVENTIS-2010SA073374</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL MUCOSAL NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>HEAD AND NECK CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>5-FU</medicinalproduct>
        <drugindication>HEAD AND NECK CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugindication>HEAD AND NECK CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141390-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GENZYME-THYM-1002140</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>KAPOSI'S SARCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSANT DRUG THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugindication>IMMUNOSUPPRESSANT DRUG THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugindication>IMMUNOSUPPRESSANT DRUG THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>IMMUNOSUPPRESSANT DRUG THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141391-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA068822</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>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTAQ</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022425</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100421</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141392-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIORBITAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROMIDEPSIN 10MG/M^2 (CELGENE)</medicinalproduct>
        <drugdosagetext>16.1 MG IV DAYS 1,8, 15</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB 150 MG (GENZYME)</medicinalproduct>
        <drugdosagetext>150 MG PO DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE (COMPAZINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE (FLOVENT HFA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM (COLACE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA-DOCUSATE (SENOKOT-S)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM HYDROXIDE (PHILLIPS MILK OF MAGNESIA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WHEAT DEXTRIN-CALCIUM COMB #15 (BENEFIBER PLUS CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMCINOLONE ACETONIDE (NASCORT AQ)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141393-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>74.8435</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
        <drugdosagetext>25 MG 1DAILY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141394-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE/LISINOPRIL</medicinalproduct>
        <drugdosagetext>20/12.5 MG EVERYDAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101104</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141395-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>66.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG EVERYDAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100925</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141396-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugdosagetext>25 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141397-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIC HYPEROSMOLAR NONKETOTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>1 GM BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101129</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141398-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
        <drugdosagetext>7.5 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
        <drugdosagetext>2550 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141399-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PHOSPHORUS DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101112</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141400-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101200475</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141401-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101200448</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>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>0RMKA84101</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>0RMKA84101</drugbatchnumb>
        <drugdosagetext>0-2-6, THEN EVERY 8 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141402-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20101202059</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IXPRIM</medicinalproduct>
        <drugauthorizationnumb>021123</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141403-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20101104066</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PALEXIA RETARD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCIATICA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PALEXIA RETARD</medicinalproduct>
        <drugauthorizationnumb>022304</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugdosagetext>PERMANENT TREATMENT WITH 0.5-0-1 DOSAGE UNITS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>1-0-0 DOSAGE UNITS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOLPERISONE</medicinalproduct>
        <drugdosagetext>3X1 TO 3X2 DOSAGE UNITS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141404-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BAYER-2010-000881</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>021400</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141405-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-BAYER-2010-000749</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>021400</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141406-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13659BP</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141407-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-12923BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>EMPHYSEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>25 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTOQ</medicinalproduct>
        <drugdosagetext>80 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BARRETT'S OESOPHAGUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>50 MCG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTASIS</medicinalproduct>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>DRY EYE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141408-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACILLUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STREPTOCOCCUS TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL DISCHARGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141409-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</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>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugdosagetext>40 MG Q2W SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141410-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB (MOAB C2B8 ANTI CD20, CHIMERIC)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMOZOLOMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141411-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141413-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>91</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141415-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-SANOFI-AVENTIS-2010SA071552</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</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>20101008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101109</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>SINTROM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141416-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201002002085</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, UNK</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060910</drugenddate>
        <drugtreatmentduration>265</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060910</drugenddate>
        <drugtreatmentduration>740</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>FLUID RETENTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060910</drugenddate>
        <drugtreatmentduration>1215</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060910</drugenddate>
        <drugtreatmentduration>675</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141417-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.9572</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HCL AND ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1 PILL PRN PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSMENORRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101121</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141418-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011002467</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>BRONCHIOLOALVEOLAR CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG ADENOCARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A738557C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141419-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200909004113</companynumb>
    <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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A551148C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141420-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201010006048</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>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141421-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201003005829</companynumb>
    <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>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF PRESSURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A629977C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A670122C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141422-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200912001840</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141423-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011007266</companynumb>
    <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>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141424-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200902001068</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.506</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID ADENOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>0.112 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugdosagetext>UNK, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081105</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141425-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011007694</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>112.47</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141426-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011002187</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>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141427-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-TEVA-252943ISR</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugauthorizationnumb>070152</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIPIPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100729</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141428-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2010SE57444</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>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>160/4.5 UG BID</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141430-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2010SE54628</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS FULMINANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101108</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROLMON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101108</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141431-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2010SE09775</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>112</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS FORTE PLUS</medicinalproduct>
        <drugauthorizationnumb>021093</drugauthorizationnumb>
        <drugdosagetext>CANDESARTAN CILEXETIL/HYDROCHLOROTHIAZIDE 32/25 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090728</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RASILEZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARMEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLATELETS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080403</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141432-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80.2867</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE ROLLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULORIC</medicinalproduct>
        <drugbatchnumb>1B1047 RL</drugbatchnumb>
        <drugdosagetext>1 TABLET DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141434-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>136.0791</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>2 TABLETS ONCE DAILY</drugdosagetext>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141437-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>68.0396</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HCL AND ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1 TO 2 EVERY FOUR HOURS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101202</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141441-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PERRIGO-10US015144</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>ELECTROCARDIOGRAM ST SEGMENT ELEVATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>072096</drugauthorizationnumb>
        <drugdosagetext>40000 MG, SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTENTIONAL OVERDOSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141442-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PERRIGO-10US013704</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>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>POLYETHYLENE GLYCOL 3350</medicinalproduct>
        <drugbatchnumb>0GR0293</drugbatchnumb>
        <drugauthorizationnumb>090685</drugauthorizationnumb>
        <drugdosagetext>17 G DAILY PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100920</drugenddate>
        <drugtreatmentduration>53</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>15 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NATEGLINIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>120 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100930</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141443-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PERRIGO-10US015112</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PYRUVIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTRANSAMINASAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTATE PYRUVATE RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUPIL FIXED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN SLOW RELEASE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>075077</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTENTIONAL OVERDOSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141445-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-SANOFI-AVENTIS-2010SA071789</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</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>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTAQ</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022425</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101011</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141446-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20101004742</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>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>RECEIVED 7 INFUSIONS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141447-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-JNJFOC-20101200506</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA TOTALIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141448-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20100203623</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>91</patientweight>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>560 (UNITS UNSPECIFIED)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTHROTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141449-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-SOLVAY-00209004996</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAROSMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 75 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071031</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COVERSYL TABLETS NOS</medicinalproduct>
        <drugauthorizationnumb>020184</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOVASCULAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141450-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-SOLVAY-00210007159</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SERUM FERRITIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISOCARD</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>POLFENON</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 150 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRESTARIUM NOS</medicinalproduct>
        <drugauthorizationnumb>020184</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:  UNKNOWN, FREQUENCY: AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 800 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORMOTEROL FUMARATE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN, FREQUENCY: TWICE A DAY (1-0-1)</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETRALEX</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINPOCETINE</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 10 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN ANTIBIOTICS</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141451-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010007002</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141452-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006811</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>ENBREL</medicinalproduct>
        <drugbatchnumb>1020933</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100928</drugenddate>
        <drugtreatmentduration>605</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141453-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010007136</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141454-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-AVENTIS-2010SA072303</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTAQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>022425</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141455-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-SOLVAY-00310007180</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CREON</medicinalproduct>
        <drugauthorizationnumb>020725</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:  20000 UNITS; 10,000 UNITS OF LIPASE TWICE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COELIAC DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CREON</medicinalproduct>
        <drugauthorizationnumb>020725</drugauthorizationnumb>
        <drugdosagetext>MEAN DAILY DOSE OF PANCREATIN WAS 45,000 UNITS OF LIPASE. TITRATED ACCORDING TO CLINICAL RESPONSE.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141461-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BAXTER-2010BH028180</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD LIQUID</medicinalproduct>
        <drugbatchnumb>LE12K147AB</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD LIQUID</medicinalproduct>
        <drugbatchnumb>LE12K147AB</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OFF LABEL USE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141462-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA072723</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>HEPATOCELLULAR INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTAQ</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022425</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141465-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH029084</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARALAST NP</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141466-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-SOLVAY-00209005002</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COVERSYL TABLETS NOS</medicinalproduct>
        <drugauthorizationnumb>020184</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141467-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-SOLVAY-00210005317</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>564</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADALAT CC</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COVERSYL NOS</medicinalproduct>
        <drugauthorizationnumb>020184</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141468-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA073310</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>TORSADE DE POINTES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTAQ</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022425</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141469-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GENZYME-THYM-1002143</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS ASSOCIATED LYMPHOPROLIFERATIVE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugbatchnumb>UNNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090220</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141470-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010AR11431</companynumb>
    <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>MECHANICAL VENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UROSEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100703</drugenddate>
        <drugtreatmentduration>1425</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100703</drugenddate>
        <drugtreatmentduration>1425</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060809</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141471-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US80666</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141472-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010TH81305</companynumb>
    <primarysource>
      <reportercountry>THAILAND</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>GLIVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400MG/DAILY</drugdosagetext>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141473-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2009US10080</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1500 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>APLASTIC ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON OVERLOAD</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141474-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US82368</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100827</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141475-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP65047</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>21</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGAMMAGLOBULINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNODEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>300 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141476-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2010GB01417</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT 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>20100727</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>25 MG TWICE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141477-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CR80735</companynumb>
    <primarysource>
      <reportercountry>COSTA RICA</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>H1N1 INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORADIL</medicinalproduct>
        <drugauthorizationnumb>020831</drugauthorizationnumb>
        <drugdosagetext>12 MCG</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFLONIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AERIUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORMOTEROL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVE DRUGS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141478-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010159477</companynumb>
    <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 DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugdosagetext>600 MG, 4X/DAY</drugdosagetext>
        <drugindication>PERIPHERAL NERVE INJURY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141479-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010146244</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>97</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST HERPETIC NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101111</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOZYM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMETEC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIART</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRANDOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141480-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2010160096</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DETRUSITOL LA</medicinalproduct>
        <drugauthorizationnumb>021228</drugauthorizationnumb>
        <drugdosagetext>4 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY INCONTINENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101126</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>850 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIABINESE</medicinalproduct>
        <drugdosagetext>250 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>150 MG, 1X/DAY, IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141481-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-PFIZER INC-2010156848</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</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>20091001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugauthorizationnumb>018972</drugauthorizationnumb>
        <drugdosagetext>1000 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
        <drugtreatmentduration>3</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>20091001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
        <drugtreatmentduration>385</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLOSA</medicinalproduct>
        <drugdosagetext>2MG DAILY</drugdosagetext>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>5MG, DAILY</drugdosagetext>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>5MG, DAILY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFENOPRIL CALCIUM</medicinalproduct>
        <drugdosagetext>42.5MG DAILY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101020</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141482-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010134824</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>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 1X/DAY IN EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST HERPETIC NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100715</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100924</drugenddate>
        <drugtreatmentduration>71</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYSLEE</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOFRANIL</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091225</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>200 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100716</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE PHOSPHATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090821</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIMATIL</medicinalproduct>
        <drugdosagetext>100 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugdosagetext>330 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080404</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugdosagetext>5 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080404</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAL</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080404</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugdosagetext>80 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATELEC</medicinalproduct>
        <drugdosagetext>10 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141483-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010IE82054</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNOSUPPRESSANT DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACARDIAC THROMBUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS NECROTISING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050574</drugauthorizationnumb>
        <drugdosagetext>25 MG</drugdosagetext>
        <drugindication>HEART TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STEROIDS NOS</medicinalproduct>
        <drugindication>HEART TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75 MG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugdosagetext>20 MG/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141484-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA76940</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>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100103</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141485-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA48126</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IRON DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL CONDITION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSFERRIN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA/ZOLEDRONATE T29581+A+</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVA D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141486-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010FR81551</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG/100 ML</drugdosagetext>
        <drugindication>OSTEOPOROTIC FRACTURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HCL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPANOR</medicinalproduct>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141487-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010ZA82191</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>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG/100 ML</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141488-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA70584</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091125</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141489-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2010GB05070</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>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT CANCER</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>20050227</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141496-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TYCO HEALTHCARE/MALLINCKRODT-T201002352</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>LEUKOENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADOSE</medicinalproduct>
        <drugauthorizationnumb>017116</drugauthorizationnumb>
        <drugdosagetext>TENFOLD NORMAL DOSE</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141497-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-TYCO HEALTHCARE/MALLINCKRODT-T201002328</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>43.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADONE</medicinalproduct>
        <drugauthorizationnumb>040517</drugauthorizationnumb>
        <drugdosagetext>30 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101105</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADONE</medicinalproduct>
        <drugauthorizationnumb>040517</drugauthorizationnumb>
        <drugdosagetext>45 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101109</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADONE</medicinalproduct>
        <drugauthorizationnumb>040517</drugauthorizationnumb>
        <drugdosagetext>60 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXINORM</medicinalproduct>
        <drugdosagetext>2.5 - 60 MG SEVERAL TIMES AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100722</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOX</medicinalproduct>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUROTEP</medicinalproduct>
        <drugdosagetext>16.8 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101122</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141498-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-TYCO HEALTHCARE/MALLINCKRODT-T201002353</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIRAY 350</medicinalproduct>
        <drugbatchnumb>V235E</drugbatchnumb>
        <drugauthorizationnumb>019710</drugauthorizationnumb>
        <drugdosagetext>15 ML, SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COMPUTERISED TOMOGRAM HEAD</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101026</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugindication>ANTIDEPRESSANT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141499-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010007182</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090715</drugenddate>
        <drugtreatmentduration>38</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141500-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ELI_LILLY_AND_COMPANY-CA201010004957</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADCIRCA</medicinalproduct>
        <drugauthorizationnumb>021368</drugauthorizationnumb>
        <drugdosagetext>40 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141501-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201012000081</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>HOSPICE CARE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141502-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201012000064</companynumb>
    <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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADCIRCA</medicinalproduct>
        <drugbatchnumb>A754322A</drugbatchnumb>
        <drugauthorizationnumb>021368</drugauthorizationnumb>
        <drugdosagetext>40 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141503-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR201011002136</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>82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>500 MG/M2, 3 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101022</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPECIAFOLDINE</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141504-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201012000076</companynumb>
    <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>40 MG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100129</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141505-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011007682</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>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141506-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-ELI_LILLY_AND_COMPANY-AT201011005794</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugdosagetext>UNK, LOADING DOSE</drugdosagetext>
        <drugindication>PERCUTANEOUS CORONARY INTERVENTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAGMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141507-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GENZYME-THYM-1002144</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>IDIOPATHIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090513</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141508-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-10P-087-0688228-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTESTINAL FISTULA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>WITHIN A CLINICAL TRIAL STUDY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141512-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2010159287</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>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>020402</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYLPROPANOLAMINE HCL</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>CYCLOBENZAPRINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORPHENIRAMINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141517-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>58.9676</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugdosagetext>3 VIALS 1/MONTH DELIVERED TO DR'S OFFICE</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141521-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING GUILTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELINGS OF WORTHLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPROPRION 150 MG</medicinalproduct>
        <drugdosagetext>3 QD PO</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141522-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2007-BP-21692BP</companynumb>
    <primarysource>
      <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>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugbatchnumb>665142A,NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020291</drugauthorizationnumb>
        <drugdosagetext>2 PUF</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugbatchnumb>665142A,NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020291</drugauthorizationnumb>
        <drugindication>EMPHYSEMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141523-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13351BP</companynumb>
    <primarysource>
      <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>ANXIETY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugbatchnumb>A55157</drugbatchnumb>
        <drugauthorizationnumb>021698</drugauthorizationnumb>
        <drugdosagetext>150 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141524-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC.-2010-RO-01394RO</companynumb>
    <primarysource>
      <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>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUTORPHANOL TARTRATE</medicinalproduct>
        <drugbatchnumb>059293A</drugbatchnumb>
        <drugauthorizationnumb>075824</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090603</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIORICET</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141525-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010007071</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>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101129</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141526-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2010SE57333</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>ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAL</medicinalproduct>
        <drugauthorizationnumb>019810</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE</medicinalproduct>
        <drugadministrationroute>003</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141527-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ASTRAZENECA-2010SE56573</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTACOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141528-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ASTRAZENECA-2010SE56357</companynumb>
    <primarysource>
      <reportercountry>CHINA</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>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>021399</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>021399</drugauthorizationnumb>
        <drugdosagetext>ONE DAY USED FOUR TABLETS, I.E. 1000 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141533-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>68.9467</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugdosagetext>10MG DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141535-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010152436</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>70.295</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL PM</medicinalproduct>
        <drugbatchnumb>E72123</drugbatchnumb>
        <drugauthorizationnumb>021394</drugauthorizationnumb>
        <drugdosagetext>2 DF, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101109</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141536-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-015982-10</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HANGOVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVIGILANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DELSYM</medicinalproduct>
        <drugbatchnumb>53615</drugbatchnumb>
        <drugdosagetext>PATIENT TOOK ANOTHER DOSE AFTER 8-8.5 HOURS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141537-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENZYME-CAMP-1001169</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>201</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEMTUZUMAB</medicinalproduct>
        <drugdosagetext>12 MG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100430</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, TIW</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100405</drugenddate>
        <drugtreatmentduration>729</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
        <drugdosagetext>1 TAB, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC</medicinalproduct>
        <drugdosagetext>1 TAB, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
        <drugdosagetext>1 TAB, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN B12 DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugdosagetext>1 TAB, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>225 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>1 MG, ONCE MONTHLY</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>VITAMIN B12 DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugdosagetext>20 U/G, QD</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOTIN</medicinalproduct>
        <drugdosagetext>1000 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090526</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>800 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090526</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CITRATE</medicinalproduct>
        <drugdosagetext>500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXALT</medicinalproduct>
        <drugdosagetext>10 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>1200 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>750 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090916</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141538-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-ASTRAZENECA-2010SE56654</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</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>ESCHERICHIA SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT CONTAMINATION MICROBIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugauthorizationnumb>019627</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEDATIVE THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141539-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHIRE-SPV1-2010-02094</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>AFFECT LABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADDERALL XR 10</medicinalproduct>
        <drugauthorizationnumb>021303</drugauthorizationnumb>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADDERALL XR 10</medicinalproduct>
        <drugauthorizationnumb>021303</drugauthorizationnumb>
        <drugdosagetext>5 MG, 1X/DAY:QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugdosagetext>UNK MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141540-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GENZYME-CAMP-1001141</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>39</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAMPATH</medicinalproduct>
        <drugbatchnumb>904983</drugbatchnumb>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGFILGRASTIM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NEUTROPENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141541-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US80966</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090309</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141542-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2010GB05360</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>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECALOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</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>20040805</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141543-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2010GB04570</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 SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYDIPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WATER INTOXICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>250 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>500 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugdosagetext>1000MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AFFECTIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIXOL                           /00876701/</medicinalproduct>
        <drugdosagetext>20MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100809</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141544-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010ES81646</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>NEPHRITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugauthorizationnumb>019201</drugauthorizationnumb>
        <drugdosagetext>50 MG, Q8H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOOTHACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100829</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141545-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP80608</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugauthorizationnumb>017963</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141547-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010DE80702</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</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>20100915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>UNK, INTERMITTENT</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141548-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR80462</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 INADEQUATELY CONTROLLED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN AMLO FIX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021990</drugauthorizationnumb>
        <drugdosagetext>160/5 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141549-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2010GB05093</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>37.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141550-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010DE79695</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</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>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOXONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141551-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-ABBOTT-10P-082-0689068-00</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</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>COMPLICATION OF PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REDUCTIL 15MG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020632</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBESITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141561-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US79549</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>ALKAPTONURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTINUCLEAR ANTIBODY INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC SPACE NARROWING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT ANKYLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PIGMENTATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCLERAL DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugauthorizationnumb>019201</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISENDRONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIOTROPIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE /SALMETEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETIMIBE/SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141562-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2010GB04213</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>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>25 MG MANE AND 50 MG NOCTE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>10MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOLTERODINE TARTRATE</medicinalproduct>
        <drugdosagetext>1 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>1 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE ^ALLEN + HANBURYS LTD^</medicinalproduct>
        <drugdosagetext>2 UNK, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141563-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2010GB04613</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIFFERENTIAL WHITE BLOOD CELL COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</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>20100920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101009</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101009</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugdosagetext>7 MG, UNK</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141564-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010PL76877</companynumb>
    <primarysource>
      <reportercountry>POLAND</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>ALBUMIN URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREATININE RENAL CLEARANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOCAL SEGMENTAL GLOMERULOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNOSUPPRESSANT DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RALES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOTAL CHOLESTEROL/HDL RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050574</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>NEPHROTIC SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>MACROLIDES</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RESPIRATORY TRACT INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>NEPHROTIC SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugindication>NEPHROTIC SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUMIN (HUMAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEHYDRATION TREATMENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141566-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2010GB04306</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>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</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>19990318</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE</medicinalproduct>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISACODYL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYOSCINE HBR HYT</medicinalproduct>
        <drugdosagetext>300 UG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYOSCINE HBR HYT</medicinalproduct>
        <drugdosagetext>600 UG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA</medicinalproduct>
        <drugdosagetext>15 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101022</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141568-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP81943</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>PULMONARY ALVEOLAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>020539</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>020539</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141569-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US79110</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>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>80 MG, BID</drugdosagetext>
        <drugindication>OEDEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>50 MG, BID</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141570-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2009US02564</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>ABSCESS DRAINAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTINOMYCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS KLEBSIELLA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED INTEREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURED SACRUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBARIC OXYGEN THERAPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR SPINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENISCUS LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO SPINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPEN REDUCTION OF FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATELLA FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOLOGICAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIOSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUBIS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIUS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVIAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URETHRAL CARUNCLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DEHISCENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LETROZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXEMESTANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141571-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2008CA16658</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>200 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080707</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080423</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080505</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugdosagetext>8 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080505</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIPRASIDONE HCL</medicinalproduct>
        <drugdosagetext>80 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080710</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEMADRIN</medicinalproduct>
        <drugdosagetext>7.5 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080902</drugenddate>
        <drugtreatmentduration>121</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUTEIN</medicinalproduct>
        <drugdosagetext>2 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080902</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141572-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010EG80375</companynumb>
    <primarysource>
      <reportercountry>EGYPT</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugindication>IRON OVERLOAD</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILYMARIN</medicinalproduct>
        <drugdosagetext>140 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOURIC</medicinalproduct>
        <drugdosagetext>300 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSOCHOL</medicinalproduct>
        <drugdosagetext>250 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101109</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141573-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010IE82059</companynumb>
    <primarysource>
      <reportercountry>IRELAND</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>ANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS NECROTISING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050574</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HEART TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050574</drugauthorizationnumb>
        <drugdosagetext>12.5 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugindication>HEART TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STEROIDS NOS</medicinalproduct>
        <drugindication>HEART TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STEROIDS NOS</medicinalproduct>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75 MG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141574-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2008US11042</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80.726</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BARRETT'S OESOPHAGUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PHOSPHORUS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE SARCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA NODOSUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOITRE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODULE ON EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL HYPOMOTILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEM CELL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROIDECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugdosagetext>3 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugdosagetext>4 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>500 MG, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>40 MG, QW</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>0.75 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELCHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYTOCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISACODYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPEUTICS NOS</medicinalproduct>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GARLIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUTRA-PHOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141576-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP80394</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>CHRONIC GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC TUBE RECONSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL SQUAMOUS CELL CARCINOMA STAGE IV</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050574</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ALLOGENIC BONE MARROW TRANSPLANTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050574</drugauthorizationnumb>
        <drugindication>GRAFT VERSUS HOST DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>ALLOGENIC BONE MARROW TRANSPLANTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>ALLOGENIC BONE MARROW TRANSPLANTATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141577-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CN82018</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141578-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ELI_LILLY_AND_COMPANY-GB201011006481</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugbatchnumb>A693292</drugbatchnumb>
        <drugauthorizationnumb>021411</drugauthorizationnumb>
        <drugdosagetext>18 MG, UNK</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101107</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPHENIDATE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141579-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201011002057</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100730</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>40 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100924</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101117</drugenddate>
        <drugtreatmentduration>54</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>15 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
        <drugtreatmentduration>119</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>30 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHYTHMY</medicinalproduct>
        <drugdosagetext>1 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100721</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugdosagetext>3 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141580-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201010000391</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>45.578</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>30 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>A725823A</drugbatchnumb>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100121</drugstartdate>
        <drugtreatmentduration>244</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN SR</medicinalproduct>
        <drugdosagetext>150 D/F, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>1 MG, EACH EVENING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141581-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011007244</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>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FUSION SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>30 MG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141582-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011007183</companynumb>
    <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>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCOHERENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>A688270A</drugbatchnumb>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100813</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>1 D/F, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100923</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100928</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZEBETA</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEKTURNA</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTAQ</medicinalproduct>
        <drugdosagetext>400 MG, 2/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN /USA/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPIRONE HCL</medicinalproduct>
        <drugdosagetext>15 MG, 2/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>30 MG, DAILY (1/D)</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141583-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201011002530</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>32.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HISTIOCYTOSIS HAEMATOPHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100929</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101006</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>15 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101026</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>15 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPITAN</medicinalproduct>
        <drugdosagetext>300 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
        <drugdosagetext>2 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100826</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugdosagetext>0.25 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DORAL</medicinalproduct>
        <drugdosagetext>15 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141584-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011006605</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugbatchnumb>A510787A</drugbatchnumb>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141585-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ELI_LILLY_AND_COMPANY-BR201011002163</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>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR SPINE FLATTENING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE IMPLANTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CONTRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BONE PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRONTAL</medicinalproduct>
        <drugdosagetext>UNK, EACH EVENING</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK, EACH EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugdosagetext>50 MG, 2/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>10 MG, EACH EVENING</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLEX</medicinalproduct>
        <drugdosagetext>30 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIOSAN</medicinalproduct>
        <drugdosagetext>5 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>70 MG, WEEKLY (1/W)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141587-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>78.4723</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISSOCIATIVE FUGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>10 MG ONCE PER DAY ORAL, PILL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101015</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141591-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20100201085</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPILIM CHRONO</medicinalproduct>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADIZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>DIURETIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADCAL -D3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>DOSE OF 100 MCG</drugdosagetext>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141592-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP80236</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugauthorizationnumb>017963</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141593-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP80604</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>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugauthorizationnumb>017963</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141594-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010155933</companynumb>
    <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>ADVIL</medicinalproduct>
        <drugauthorizationnumb>020402</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141595-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2010152814</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugindication>OROPHARYNGEAL PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugindication>PYREXIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141596-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-PFIZER INC-SE-WYE-G06831210</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</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>ARTHRITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugauthorizationnumb>009987</drugauthorizationnumb>
        <drugdosagetext>5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugdosagetext>7.5 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141597-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010007222</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>250 A?G, UNK</drugdosagetext>
        <drugindication>THROMBOCYTOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090702</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141598-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010004714</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>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100407</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</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>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>PRANDIN                            /00882701/</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>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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141599-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010AR14215</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>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FTY 720 FTY+</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100318</drugenddate>
        <drugtreatmentduration>640</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FTY 720 FTY+</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100916</drugenddate>
        <drugtreatmentduration>182</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIANE - 35</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100915</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141600-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010AR18309</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FTY 720 FTY+</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>MATERNAL DOSE 0.5MG</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141601-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US82338</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>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141602-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP80606</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>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugauthorizationnumb>017963</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141606-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>61.2356</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOVIPREP</medicinalproduct>
        <drugindication>COLONOSCOPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141609-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67.586</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL 100MG TAB</medicinalproduct>
        <drugdosagetext>100MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUTY ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101011</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141610-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20100509212</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>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141611-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101200455</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141614-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57.6068</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INNER EAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERBINAFINE HCL</medicinalproduct>
        <drugdosagetext>250 MG ONCE DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ONYCHOMYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100907</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141618-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>56.6996</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>100 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141620-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>72.5755</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXILANT</medicinalproduct>
        <drugdosagetext>2 X 2 @ DAY</drugdosagetext>
        <drugindication>DRUG THERAPY CHANGED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101106</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141621-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0688073-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</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>7141622-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-10P-087-0648777-00</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER STAGE IV</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPLIN SR FOR INJECTION 11.25 MG</medicinalproduct>
        <drugbatchnumb>UNKN0WN</drugbatchnumb>
        <drugauthorizationnumb>020708</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100302</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BICALUTAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER STAGE IV</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090413</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090609</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>HEPATIC FUNCTION ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090609</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100318</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORMADINONE ACETATE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090707</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141623-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ALEXION-A201001531</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIRIS</medicinalproduct>
        <drugdosagetext>600 MG, QW</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAROXYSMAL NOCTURNAL HAEMOGLOBINURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071204</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIRIS</medicinalproduct>
        <drugdosagetext>900 MG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN                          /00261401/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPALGIC                           /00599202/</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141624-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ALEXION-A201001506</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIRIS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAROXYSMAL NOCTURNAL HAEMOGLOBINURIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141625-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20101003014</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugdosagetext>AVERAGE INITIAL DOSE OF 3 TO 5 MG/KG AT WEEK 0, WEEK 2, WEEK 6 AND THEN EVERY SIX TO EIGHT WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SARCOIDOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141626-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20101003046</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION PSEUDOMONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugdosagetext>INITIAL DOSE OF 3 TO 5 MG/KG AT WEEK 0, WEEK 2, WEEK 6 AND THEN EVERY SIX TO EIGHT WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SARCOIDOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141627-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2009DE14346</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPIGASTRIC DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR RETARDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLOW RESPONSE TO STIMULI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>400-0-500 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARTIAL SEIZURES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090214</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090221</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>750 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARTIAL SEIZURES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
        <drugdosagetext>5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>12.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOL</medicinalproduct>
        <drugdosagetext>1 MEQ, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TICLOPIDINE HCL</medicinalproduct>
        <drugdosagetext>250 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBELLAR INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141628-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2009CA19062</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>METASTATIC CARCINOID TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090413</drugstartdate>
      </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>7141629-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA64039</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</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>EAR INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>60 MG, EVERY 3 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CARCINOID TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040320</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>30 MG, TIW</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141630-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA60427</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>20 MG, QW4</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>NEUROENDOCRINE TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100812</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141631-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2009JP44898</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>42</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081208</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>100 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOCYTOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHROMOSOME ANALYSIS ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PLATELET COUNT ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091113</drugenddate>
        <drugtreatmentduration>393</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PLATELET COUNT INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091208</drugenddate>
        <drugtreatmentduration>418</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIENAM</medicinalproduct>
        <drugdosagetext>1 G</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081218</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUNGUARD</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091215</drugenddate>
        <drugtreatmentduration>372</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRODIF</medicinalproduct>
        <drugdosagetext>200 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081218</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081225</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081225</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141632-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BE58641</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>20 MG, QMO</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ILEAL FISTULA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141633-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2010GB05609</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>MYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOPHLEBITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141634-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010DE81006</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>UNK, FOR 3 MONTHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141635-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA39459</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLIATIVE CARE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>40 MG, EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SMALL INTESTINE CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101125</drugenddate>
        <drugtreatmentduration>666</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>40 MG, QMO</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141636-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA059681</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>98.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STUDY MEDICATION NOT GIVEN</medicinalproduct>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STUDY MEDICATION NOT GIVEN</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100725</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>2 PUFFS EVERY 4 HR AS NEEDED</drugdosagetext>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
        <drugdosagetext>15 MG AT HOURSLEEP PRN</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141637-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.0396</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>NERVOUSNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141638-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MPIJNJ-2010-03131</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021602</drugauthorizationnumb>
        <drugdosagetext>1.8 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070709</drugenddate>
        <drugtreatmentduration>67</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROMIDEPSIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>14 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080731</drugenddate>
        <drugtreatmentduration>455</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070710</drugenddate>
        <drugtreatmentduration>68</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONEFOS</medicinalproduct>
        <drugdosagetext>1.6 G, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070727</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRAZEPAM</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SEDATIVE THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080828</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>900 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALACICLOVIR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRACTIN                          /00006201/</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIURETIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIEMETIC SUPPORTIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SEDATIVE THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070906</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070727</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIDOXINE HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLOW-K</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070906</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOTRIMAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIFUNGAL TREATMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080306</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141641-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-12226BP</companynumb>
    <primarysource>
      <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>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141642-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101204</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13723BP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SUBARACHNOID HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141643-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20101003050</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugdosagetext>INITIAL DOSE OF 3 TO 5 MG/KG AT WEEK 0, WEEK 2, WEEK 6 AND THEN EVERY SIX TO EIGHT WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SARCOIDOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141644-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20101003048</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LEUKOENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugdosagetext>INITIAL DOSE OF 3 TO 5 MG/KG AT WEEK 0, WEEK 2, WEEK 6 AND THEN EVERY SIX TO EIGHT WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SARCOIDOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141645-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-254921USA</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>SKIN NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugbatchnumb>P53361</drugbatchnumb>
        <drugauthorizationnumb>020622</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INTERFERON BETA-1A</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141646-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-257926USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugauthorizationnumb>020622</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141647-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-AVENTIS-2010SA067505</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT CC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141648-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-BAXTER-2010BH028676</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD LIQUID</medicinalproduct>
        <drugbatchnumb>LE12J074BX</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>THROMBOCYTOPENIA NEONATAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD LIQUID</medicinalproduct>
        <drugbatchnumb>LE12J074BX</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OFF LABEL USE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD LIQUID</medicinalproduct>
        <drugbatchnumb>LE12J074BX</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD LIQUID</medicinalproduct>
        <drugbatchnumb>LE12J074BX</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INTRAVENOUS CATHETER MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101106</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141649-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BAXTER-2010BH029310</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD LIQUID</medicinalproduct>
        <drugbatchnumb>LE12K051AC</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPOGAMMAGLOBULINAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTHYROIDISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141650-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP66280</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugauthorizationnumb>019201</drugauthorizationnumb>
        <drugdosagetext>3 TO 4 TIMES A WEEK</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugauthorizationnumb>019201</drugauthorizationnumb>
        <drugdosagetext>25 MG ONCE EVERY TWO DAYS</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NU-LOTAN</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>15 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLDANA</medicinalproduct>
        <drugdosagetext>12 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
        <drugdosagetext>0.25 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugdosagetext>0.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141652-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.6996</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYDIPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>20 MG ONCE DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugdosagetext>100 MG ONCE DIALY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DECREASED APPETITE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101020</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141655-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA80205</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091128</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141656-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA79944</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141657-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR80707</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugbatchnumb>UNK.</drugbatchnumb>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5MG/100ML</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141658-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR80524</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>CATARACT OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugbatchnumb>UNK.</drugbatchnumb>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5MG/100ML</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141659-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US80907</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141660-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US80982</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugbatchnumb>F0126</drugbatchnumb>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100929</drugenddate>
        <drugtreatmentduration>99</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141662-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76.2043</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT BEARING DIFFICULTY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN 250 MG WOLTERS KLUWER HEALTH, INC</medicinalproduct>
        <drugbatchnumb>10</drugbatchnumb>
        <drugdosagetext>TWICE DAILY 250 MG TWICE DAILY #10</drugdosagetext>
        <drugindication>DIVERTICULITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101030</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN 250 MG WOLTERS KLUWER HEALTH, INC</medicinalproduct>
        <drugbatchnumb>10</drugbatchnumb>
        <drugdosagetext>250 MG TWICE DAILY #10</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101104</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141663-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US80003</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLONIC FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100222</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141664-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010AU75974</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNDERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100913</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>25 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>2.5 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141665-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-BAXTER-2010BH021373</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMICEPHALALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD LIQUID</medicinalproduct>
        <drugbatchnumb>LE12J396AG</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100806</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD LIQUID</medicinalproduct>
        <drugbatchnumb>LE12J396AG</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OFF LABEL USE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100806</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD LIQUID</medicinalproduct>
        <drugbatchnumb>LE12K065AH</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100806</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD LIQUID</medicinalproduct>
        <drugbatchnumb>LE12K065AH</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100806</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD LIQUID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100319</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD LIQUID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100319</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD LIQUID</medicinalproduct>
        <drugbatchnumb>LE12KA64AG</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD LIQUID</medicinalproduct>
        <drugbatchnumb>LE12KA64AG</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD LIQUID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100903</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD LIQUID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100903</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD LIQUID</medicinalproduct>
        <drugbatchnumb>LE12K098AB</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD LIQUID</medicinalproduct>
        <drugbatchnumb>LE12K098AB</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD LIQUID</medicinalproduct>
        <drugbatchnumb>LE12K089AC</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD LIQUID</medicinalproduct>
        <drugbatchnumb>LE12K089AC</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD LIQUID</medicinalproduct>
        <drugbatchnumb>LE12K176AB</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD LIQUID</medicinalproduct>
        <drugbatchnumb>LE12K176AB</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD LIQUID</medicinalproduct>
        <drugbatchnumb>LE12K158AF</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD LIQUID</medicinalproduct>
        <drugbatchnumb>LE12K158AF</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD LIQUID</medicinalproduct>
        <drugbatchnumb>LE12K176AD</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD LIQUID</medicinalproduct>
        <drugbatchnumb>LE12K176AD</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOLON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUSPATAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UBRETID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100825</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIZANIDINE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIDEPRESSANTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROPINIROLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141666-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20101106903</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>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>1 INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141668-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20101108926</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CANDIDA SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141669-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-JNJFOC-20101200487</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>8TH INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
        <drugindication>PROSTATOMEGALY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMSULOSIN</medicinalproduct>
        <drugindication>PROSTATOMEGALY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141670-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20090805304</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPENDICITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STREPTOCOCCUS TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTOCORT EC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MERCAPTOPURINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>500-100-40</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGESTIVE ADVANTAGE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIPLE VITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CULTURELLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141671-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010VE80596</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</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>MEDICAL DEVICE REMOVAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORZEM</medicinalproduct>
        <drugdosagetext>120 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TROPOCER</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CILOSTAZOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAFLOM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULODEXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSTAL</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141672-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010AU80671</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOOSE TOOTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH LOSS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091013</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141673-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR80383</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugbatchnumb>UNK.</drugbatchnumb>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141674-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010AT80295</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>KERATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141675-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US80329</companynumb>
    <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>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141676-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2009CA49055</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAST APPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LISTERIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5MG/100CC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091103</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141677-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA072131</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>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>OF262A</drugbatchnumb>
        <drugdosagetext>DOSE:23 UNIT(S)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLOSTAR</medicinalproduct>
        <drugbatchnumb>OF262A</drugbatchnumb>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
        <drugdosagetext>5-500 BID</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141678-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2010SE56905</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>PNEUMONIA LEGIONELLA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
        <drugauthorizationnumb>020441</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101123</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141679-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010VE77123</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTIOUS MONONUCLEOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG/YEAR</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>MENOPAUSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141680-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR80719</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugbatchnumb>UNK.</drugbatchnumb>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5MG/100ML</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141681-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010MX80667</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>1 APPLICATION (5 MG/100 ML) YEARLY IV ON INFUSION</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141682-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA65655</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141683-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010KR16625</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>44</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED GASTRIC EMPTYING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>7.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101030</drugenddate>
        <drugtreatmentduration>158</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugdosagetext>800 MG/M^2</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101030</drugenddate>
        <drugtreatmentduration>158</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>100 MG/M^2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101026</drugenddate>
        <drugtreatmentduration>154</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141684-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA80528</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091210</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141685-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA61254</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091107</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141686-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR80722</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>GENERAL PHYSICAL CONDITION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEELCHAIR USER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugbatchnumb>UNK.</drugbatchnumb>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5MG/100ML</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141687-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US82276</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>NEORAL</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100903</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141688-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US80909</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>
      <reaction>
        <reactionmeddrapt>GENE MUTATION IDENTIFICATION TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KAPOSI'S SARCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>800 MG, QD</drugdosagetext>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141689-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP80441</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFUSE ALVEOLAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC EMBOLUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTERSTITIAL LUNG DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090416</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAKTAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGLAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS NOS</medicinalproduct>
        <drugdosagetext>25 MG DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIFUNGAL DRUGS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141690-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENZYME-FABR-1001648</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FABRAZYME</medicinalproduct>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FABRY'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091204</drugenddate>
        <drugtreatmentduration>45</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FABRAZYME</medicinalproduct>
        <drugdosagetext>105 MG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091021</drugenddate>
        <drugtreatmentduration>2178</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141693-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.7716</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE</medicinalproduct>
        <drugbatchnumb>D0534A</drugbatchnumb>
        <drugdosagetext>2.5 ALBUTEROL SULFATE 3 X DAY</drugdosagetext>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100823</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141696-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>49.8957</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugdosagetext>1 TABLET TWICE DAY</drugdosagetext>
        <drugindication>CYSTITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100910</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141697-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA072412</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71.65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090720</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED THERAPY</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100507</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED THERAPY</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090718</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIAZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN 70/30</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUTEIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIL SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEO-DUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141698-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-AVENTIS-2010SA071661</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTENTIONAL OVERDOSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXOMIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTENTIONAL OVERDOSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTENTIONAL OVERDOSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STABLON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141699-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH025753</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>PENILE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101129</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141700-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20101202271</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141701-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101103144</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>APHASIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUCYNTA</medicinalproduct>
        <drugauthorizationnumb>022304</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141702-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101103230</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>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUCYNTA</medicinalproduct>
        <drugauthorizationnumb>022304</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141703-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101104195</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUCYNTA</medicinalproduct>
        <drugauthorizationnumb>022304</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141704-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20100108521</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141705-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20101104528</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACTERIAL PYELONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HISTIOCYTOSIS HAEMATOPHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>APPROXIMATELY 40TH DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141706-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20101107333</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FINIBAX</medicinalproduct>
        <drugauthorizationnumb>022106</drugauthorizationnumb>
        <drugdosagetext>0.5 G THREE TIMES DAILY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GRANULOCYTE COLONY-STIMULATING FACTOR</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIKACIN SULFATE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER NON-THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLATELETS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELL TRANSFUSION</medicinalproduct>
        <drugdosagetext>STOP DATE = 16-NOV-2010</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141707-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-JNJFOC-20101201185</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVERSION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCREAMING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141708-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-JNJFOC-20101105789</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</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>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141709-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-10P-087-0648849-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BILE DUCT CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPLIN SR FOR INJECTION 11.25 MG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020708</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER STAGE II</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BICALUTAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER STAGE II</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BICALUTAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090824</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTAMIDE</medicinalproduct>
        <drugindication>PROSTATE CANCER STAGE II</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090727</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugindication>LIVER DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090727</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141710-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-BAXTER-2010BH028012</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141711-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-AVENTIS-2010SA071959</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>AKATHISIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100609</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100609</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100609</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100609</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELPERONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100609</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141712-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-AVENTIS-2010SA071637</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CIRCULATORY FAILURE NEONATAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>016273</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060824</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>016273</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060824</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141713-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010005253</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1023549</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141714-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006996</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL DETACHMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1021462</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141715-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENZYME-FABR-1001649</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL HERNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FABRAZYME</medicinalproduct>
        <drugdosagetext>105 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FABRY'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FABRAZYME</medicinalproduct>
        <drugdosagetext>105 MG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091021</drugenddate>
        <drugtreatmentduration>1447</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FABRAZYME</medicinalproduct>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091204</drugenddate>
        <drugtreatmentduration>45</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FABRAZYME</medicinalproduct>
        <drugdosagetext>35 MG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100322</drugenddate>
        <drugtreatmentduration>69</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FABRAZYME</medicinalproduct>
        <drugdosagetext>55 MG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100423</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FABRAZYME</medicinalproduct>
        <drugdosagetext>35 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100913</drugenddate>
        <drugtreatmentduration>124</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FABRAZYME</medicinalproduct>
        <drugdosagetext>70 MG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101025</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141716-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101103087</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>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN EPITHELIAL CANCER RECURRENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXIL</medicinalproduct>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugdosagetext>UNSPECIFIED DOSE EVERY 4-7 WEEKS FOR 5 YEARS; CUMULATIVE DOSE 2070 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN EPITHELIAL CANCER RECURRENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141717-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-JNJFOC-20101201814</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141718-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-JNJFOC-20101202166</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>HYPERPYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAELYX</medicinalproduct>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141719-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028112</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>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101109</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141720-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-AVENTIS-2010SA071988</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INTENTIONAL OVERDOSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEPRONIZINE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INTENTIONAL OVERDOSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141721-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BAXTER-2010BH029125</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>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CANDIDIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CILEST</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOTRIMAZOLE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CANDIDIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141722-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010RU73307</companynumb>
    <primarysource>
      <reportercountry>RUSSIAN FEDERATION</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELIDEL</medicinalproduct>
        <drugauthorizationnumb>021302</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DERMATITIS ATOPIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFABOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100326</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100326</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAVEGIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100326</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAPAVERINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100326</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUPHYLLINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100326</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101018</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIFIDUMBACTERIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101018</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MACROPEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FURAMAGS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUBICOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANEPHRONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141723-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010AU80248</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>650 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070507</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101122</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141724-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010IT76517</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugauthorizationnumb>019201</drugauthorizationnumb>
        <drugdosagetext>75 /3 MG/ML, UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100703</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THIOCOLCHICOSIDE</medicinalproduct>
        <drugdosagetext>4 MG</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100703</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141725-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR27621</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEPONEX</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>300 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100425</drugenddate>
        <drugtreatmentduration>65</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugdosagetext>2 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141726-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010AU56015</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG ADENOCARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141727-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAXTER-2010BH028585</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</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>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL PD-2 W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141728-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>61.2356</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugdosagetext>1 RING MONTHLY</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141729-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.0396</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WALKING AID USER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>80 MG 1/DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADODART</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE HGI</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYLTONIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141730-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.8957</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugbatchnumb>Z1747</drugbatchnumb>
        <drugdosagetext>1 TABLET DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101111</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141731-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.1834</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE, 80 MG - ETHIC</medicinalproduct>
        <drugdosagetext>5 - 80S A DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141732-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-KINGPHARMUSA00001-K201001442</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BEDRIDDEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOARAIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMAL PRESSURE HYDROCEPHALUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugauthorizationnumb>019901</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>17.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NORMAL PRESSURE HYDROCEPHALUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELPERONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141733-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-KINGPHARMUSA00001-K201001184</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KLEBSIELLA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugauthorizationnumb>019901</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100528</drugenddate>
        <drugtreatmentduration>730</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugdosagetext>75 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100528</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>850 AND 1000 MG DAILY</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100529</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>600 MG, QID</drugdosagetext>
        <drugindication>NEUROBORRELIOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTEX</medicinalproduct>
        <drugdosagetext>25/100 MG TWICE</drugdosagetext>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIANI</medicinalproduct>
        <drugdosagetext>25/125 MCG 2 PUFFS DAILY</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100525</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141734-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-AVENTIS-2010SA072981</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELPLAT</medicinalproduct>
        <drugauthorizationnumb>021759</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090629</drugenddate>
        <drugtreatmentduration>487</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELPLAT</medicinalproduct>
        <drugauthorizationnumb>021759</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100119</drugenddate>
        <drugtreatmentduration>487</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELPLAT</medicinalproduct>
        <drugauthorizationnumb>021759</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100413</drugenddate>
        <drugtreatmentduration>487</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELPLAT</medicinalproduct>
        <drugauthorizationnumb>021759</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101028</drugenddate>
        <drugtreatmentduration>487</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101028</drugenddate>
        <drugtreatmentduration>283</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101028</drugenddate>
        <drugtreatmentduration>45</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101028</drugenddate>
        <drugtreatmentduration>199</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM LEVOFOLINATE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>5-FU</medicinalproduct>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>5-FU</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100629</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141735-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101128</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-JNJFOC-20100908527</companynumb>
    <primarysource>
      <reportercountry>IRELAND</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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>ORMA60802</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIRITON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSEC MUPS (OMEPRAZOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS HCT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141736-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-BAXTER-2010BH028845</companynumb>
    <primarysource>
      <reportercountry>NORWAY</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>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD LIQUID</medicinalproduct>
        <drugbatchnumb>LE12K072AG</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPOGAMMAGLOBULINAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141737-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010152381</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>COELIAC DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAPSTICK LIP BALM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141738-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028944</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>HAEMOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD LIQUID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141739-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-MEDIMMUNE-MEDI-0011636</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>6.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>BRONCHOPULMONARY DYSPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100809</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALINE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141740-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-MEDIMMUNE-MEDI-0011837</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>4.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGODIPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141741-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-MEDIMMUNE-MEDI-0011871</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>5.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICONAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141742-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-BAXTER-2010BH029090</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD LIQUID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSERING ONBEKEND I.V.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MOTOR NEURONE DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100918</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD LIQUID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSERING ONBEKEND I.V.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OFF LABEL USE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100918</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141743-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GENZYME-FABR-1000130</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FABRAZYME</medicinalproduct>
        <drugindication>FABRY'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141744-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-MEDIMMUNE-MEDI-0011833</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>4.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141745-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-MEDIMMUNE-MEDI-0011760</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>BRONCHOPULMONARY DYSPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIDOXINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RETINOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141746-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-JPNCT2010004161</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>VARICOSE VEIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DENOSUMAB</medicinalproduct>
        <drugdosagetext>DENOSUMAB 60MG OR PLACEBO</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEW CALCICHEW D3</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090525</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141747-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-AMGEN-QUU436554</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE COLOUR ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIMPARA</medicinalproduct>
        <drugbatchnumb>1017606</drugbatchnumb>
        <drugauthorizationnumb>021688</drugauthorizationnumb>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPARATHYROIDISM PRIMARY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100816</drugenddate>
        <drugtreatmentduration>92</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>T4</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141748-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU431249</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>NPLATE</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>4 A?G/KG, UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090422</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090422</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141749-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-QUU414121</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070327</drugenddate>
        <drugtreatmentduration>47</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>25 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070905</drugenddate>
        <drugtreatmentduration>134</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>25 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>25 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071205</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>25 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080806</drugenddate>
        <drugtreatmentduration>224</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081001</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100414</drugenddate>
        <drugtreatmentduration>554</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>15 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSIL-10</medicinalproduct>
        <drugdosagetext>45 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIDOXAL PHOSPHATE</medicinalproduct>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMETEC</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>D ALFA</medicinalproduct>
        <drugdosagetext>1 A?G, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MENATETRENONE</medicinalproduct>
        <drugdosagetext>45 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBAMIPIDE</medicinalproduct>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
        <drugdosagetext>1500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYSLEE</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>35 MG, QWK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN SODIUM</medicinalproduct>
        <drugdosagetext>180 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>2 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141750-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC.-2010-RO-01352RO</companynumb>
    <primarysource>
      <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>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUTORPHANOL TARTRATE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>075824</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141751-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-11144PF</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK LEFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTRICTIVE CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TROPONIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANASTROZOLE</medicinalproduct>
        <drugdosagetext>1 MG</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>150 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugdosagetext>20 MCG</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>25 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugdosagetext>500 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>1000 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D3</medicinalproduct>
        <drugdosagetext>1000 U</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141752-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13461BP</companynumb>
    <primarysource>
      <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>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS HCT</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021162</drugauthorizationnumb>
        <drugdosagetext>80/12.5MG; QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>37.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141753-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-NOVOPROD-319495</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOMIX 30 FLEXPEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021172</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141754-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-319168</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>
      <patientweight>93.878</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</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>20100820</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>1.2 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>1.8 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>1000 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100908</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141755-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NOVOPROD-318879</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>
      <patientweight>50</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HYPOMOTILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugbatchnumb>NA</drugbatchnumb>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>0.3 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100808</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugbatchnumb>N/A</drugbatchnumb>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>0.6 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100814</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugbatchnumb>N/A</drugbatchnumb>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>0.9 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
        <drugtreatmentduration>70</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCYRON                           /00466401/</medicinalproduct>
        <drugdosagetext>6 TAB, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETIZOLAM</medicinalproduct>
        <drugdosagetext>1.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAUZELIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141756-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-NOVOPROD-312515</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>111.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIRAGLUTIDE FLEXPEN</medicinalproduct>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>1.8 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100727</drugenddate>
        <drugtreatmentduration>383</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>1700 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>1700 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMIPRAMINE</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
        <drugdosagetext>60 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141757-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NOVOPROD-319112</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>
      <patientweight>102</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STILL'S DISEASE ADULT ONSET</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugbatchnumb>NA</drugbatchnumb>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>0.3 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100820</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>0.9 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>1 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100820</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100112</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141758-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RU-NOVOPROD-319384</companynumb>
    <primarysource>
      <reportercountry>RUSSIAN FEDERATION</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTAPHANE HM PENFILL</medicinalproduct>
        <drugbatchnumb>YS62121</drugbatchnumb>
        <drugauthorizationnumb>019959</drugauthorizationnumb>
        <drugdosagetext>35 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTRAPID HM PENFILL</medicinalproduct>
        <drugdosagetext>32 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141759-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-NOVOPROD-317916</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>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIC SEIZURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VICTIM OF CRIME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLIN 70/30</medicinalproduct>
        <drugauthorizationnumb>019991</drugauthorizationnumb>
        <drugindication>OFF LABEL USE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141760-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>57.6068</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT SUBSTITUTION ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>60 MG 2X A DAY</drugdosagetext>
        <drugindication>NERVE INJURY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>60 MG 2X A DAY</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141761-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-SANOFI-AVENTIS-2010SA071704</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>
      <patientweight>61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>POLYNEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>021759</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>021759</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARCUMAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZURCAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141762-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20101202278</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>1</drugcharacterization>
        <medicinalproduct>DUROTEP MT</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141763-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20100607212</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>LIGAMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD URINE PRESENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141764-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NOVOPROD-317515</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>42</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN-LOSING GASTROENTEROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORDITROPIN NORDIFLEX CHU</medicinalproduct>
        <drugbatchnumb>N/A</drugbatchnumb>
        <drugauthorizationnumb>021148</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UNIVENTRICULAR HEART</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UNIVENTRICULAR HEART</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DORNER</medicinalproduct>
        <drugdosagetext>60 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UNIVENTRICULAR HEART</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALART</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROTEIN-LOSING GASTROENTEROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROMIA                           /00023520/</medicinalproduct>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141765-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-319278</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.84</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>0.6 MG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>1.2 UNK, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>1.8 MG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101105</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141766-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NOVOPROD-319492</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>
      <patientweight>44</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugbatchnumb>N/A</drugbatchnumb>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>0.3 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100907</drugstartdate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>0.6 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>0.9 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALBLOCK</medicinalproduct>
        <drugdosagetext>8 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugdosagetext>8 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141768-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2010SE56632</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>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100201</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</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>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>PAIN IN EXTREMITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141769-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GENENTECH-310358</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>CILIARY MUSCLE SPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRIDOCELE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANIBIZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>0.05 ML, UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141770-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-GENENTECH-302311</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>APHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE MENOPAUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100907</drugenddate>
        <drugtreatmentduration>462</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEFLAZACORT</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIMESULIDE</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <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>DRAMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIDOXINE HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>NAUSEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141773-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GENENTECH-310335</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>LUCENTIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>0.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100525</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141774-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CZ-GENENTECH-309115</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>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS FULMINANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>375 MG/M2, Q3M</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090828</drugenddate>
        <drugtreatmentduration>190</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APO-OME</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUTHYROX</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141775-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20101200543</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT MELANOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS (NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141776-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-GENENTECH-310372</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1000 MG, 1/MONTH</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HENOCH-SCHONLEIN PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141777-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GENENTECH-306906</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141778-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GENZYME-POMP-1001211</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>MYOZYME</medicinalproduct>
        <drugdosagetext>20 MG/KG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLYCOGEN STORAGE DISEASE TYPE II</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100623</drugenddate>
        <drugtreatmentduration>160</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>5.5 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>75 MG, QOD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141781-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>101.6057</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHLEBITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENTYL</medicinalproduct>
        <drugdosagetext>20MG/2ML Q 8?  GIVEN I.V.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141782-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>77.1115</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>10 UNITS 3 X A DAY INJECTION IN STOMACH</drugdosagetext>
        <drugindication>BLOOD GLUCOSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141783-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033806</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>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141784-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-690197</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>ESCHERICHIA SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UROSEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BELATACEPT</medicinalproduct>
        <drugdosagetext>MORE INTENSIVE REGIMEN; FORM PER PROTOCOL</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141785-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-450689</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST PROSTHESIS REMOVAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROADENOMA OF BREAST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL DRYNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19911204</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141786-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-452338</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>ANAL FISSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>THERAPY WITH ISOTRETINOIN FOR FOUR TO FIVE MONTHS.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141787-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-628941</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLANGITIS SCLEROSING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021017</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>ACCUTANE 40 QD/BID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>ACCUTANE 40 12 TABS PER WK (BID M-F; QD ON WEEKENDS).</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030320</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141788-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-ROCHE-641888</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>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASTUZUMAB</medicinalproduct>
        <drugdosagetext>LOADING DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASTUZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>THERAPY DURATION FOR 12 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090514</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141789-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-649304</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>ANAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANORECTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL HERPES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020829</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>DOSE INCREASED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020926</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>DOSE INCREASED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO TRI-CYCLEN</medicinalproduct>
        <drugindication>MENSTRUATION IRREGULAR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO TRI-CYCLEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141790-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-673159</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>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOTRETINOIN</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACNE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141792-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.7716</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLATIRAMER ACETATE</medicinalproduct>
        <drugbatchnumb>P53377</drugbatchnumb>
        <drugdosagetext>PREFILLED SYRINGES 20 MG/ML</drugdosagetext>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141793-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>100</patientweight>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50MG WEEKLY SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141795-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-692179</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugbatchnumb>B0003</drugbatchnumb>
        <drugdosagetext>FORM: INFUSION,LAST DOSE PRIOR TO SAE: 12 DECEMBER 2009. TEMPORARILY INTERRUPTED</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugbatchnumb>B0003</drugbatchnumb>
        <drugdosagetext>FREQUENCY: 84 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090707</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091024</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141796-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-694872</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100322</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100322</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141797-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BAXTER-2010BH029136</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>GASTROENTERITIS CLOSTRIDIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAL ABSCESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100819</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN REDIBAG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAL ABSCESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100819</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TILIDINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROCTALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101028</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141798-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-719883</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>ONLY ONCE.</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100705</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100705</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100326</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLARICID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMELTEON</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100705</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100705</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100705</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100309</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141799-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-727852</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOBILIARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TORSADE DE POINTES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>B6004</drugbatchnumb>
        <drugdosagetext>DOSE LEVEL:15 MG/KG. DATE OF LAST DOSE PRIOR TO SAE:10 SEPTEMBER 2010. DOSE FORM:VIALS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASTUZUMAB</medicinalproduct>
        <drugbatchnumb>B1559</drugbatchnumb>
        <drugdosagetext>DOSE LEVEL:6 MG/KG. DATE OF LAST DOSE PRIOR TO SAE:10 SEPTEMBER 2010. DOSE FORM:VIALS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugbatchnumb>D0A152</drugbatchnumb>
        <drugdosagetext>DOSE LEVEL:75 MG/M2.DATE OF LAST DOSE PRIOR TO SAE:10 SEPTEMBER 2010.DOSE FORM:VIALS.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugbatchnumb>D0A152</drugbatchnumb>
        <drugdosagetext>DOSE REDUCED BY ONE DOSE LEVEL. DOSE LEVEL:60 MG/M2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>DOSE LEVEL:6 AUC. DATE OF LAST DOSE PRIOR TO SAE:10 SEPTEMBER 2010. DOSE FORM:VIALS.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>DOSE REDUCED BY ONE DOSE LEVEL. DOSE LEVEL:5 AUC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141800-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>MY-SANOFI-AVENTIS-2010SA072478</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>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020905</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141801-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-730855</companynumb>
    <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>FUNGAL SKIN INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2A</medicinalproduct>
        <drugdosagetext>FORM; PRE FILLED SYRINGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBASPHERE</medicinalproduct>
        <drugdosagetext>IN DIVIDED DOSES ^ RIBAPAK^ PAR</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>DRUG REPORTED AS SINGULAR</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN CR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENTYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINERAL TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141802-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-734823</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTRENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALGANCICLOVIR HCL</medicinalproduct>
        <drugauthorizationnumb>021304</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100926</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALGANCICLOVIR HCL</medicinalproduct>
        <drugauthorizationnumb>021304</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugdosagetext>FREQUENCY: NOT REPORTED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101030</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVEROLIMUS</medicinalproduct>
        <drugdosagetext>FREQUENCY: NOT REPORTED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100904</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVEROLIMUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVEROLIMUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>FREQUENCY: NOT REPORTED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>DOSE DECREASED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugdosagetext>TDD: 400</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100904</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERENOA REPENS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERENOA REPENS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISOPROLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARBEPOETIN ALFA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARBEPOETIN ALFA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101012</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141803-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-AVENTIS-2010SA063062</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELPLAT</medicinalproduct>
        <drugauthorizationnumb>021759</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100507</drugenddate>
        <drugtreatmentduration>141</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELPLAT</medicinalproduct>
        <drugauthorizationnumb>021759</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100924</drugenddate>
        <drugtreatmentduration>141</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100507</drugenddate>
        <drugtreatmentduration>141</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100924</drugenddate>
        <drugtreatmentduration>141</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100716</drugenddate>
        <drugtreatmentduration>71</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100924</drugenddate>
        <drugtreatmentduration>71</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM LEVOFOLINATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100507</drugenddate>
        <drugtreatmentduration>141</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM LEVOFOLINATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100924</drugenddate>
        <drugtreatmentduration>141</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141804-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-736557</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>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBULOINTERSTITIAL NEPHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>NOTE: DOSAGE IS UNCERTAIN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugdosagetext>DOSE FORM: PERORAL AGENT, NOTE: DOSAGE IS UNCERTAIN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON BETA NOS</medicinalproduct>
        <drugdosagetext>NOTE: DOSAGE IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141805-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAXTER-2010BH029225</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141806-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-ROCHE-737514</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>94</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>9 HERCEPTIN ADMINISTRATIONS.  ADJUVANT TRASTUZUMAB</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100303</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>BATCH NUMBER : NUMEROUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugdosagetext>CUMULATIVE DOSE:300MG/M2 EPIRUBICIN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100414</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100616</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141807-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>GR-SANOFI-AVENTIS-2010SA073198</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020905</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141808-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-739807</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>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugauthorizationnumb>017533</drugauthorizationnumb>
        <drugdosagetext>OTHER INDICATION: SLEEP PROBLEM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091208</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141809-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033785</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>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101103</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141810-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GENZYME-THYM-1001923</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>19</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE GRAFT VERSUS HOST DISEASE IN SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE LYMPHOCYTIC LEUKAEMIA RECURRENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100416</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100426</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100505</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDARABINE PHOSPHATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100423</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100425</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOPRIM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100426</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100726</drugenddate>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM TRIHYDRATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100415</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIAPENEM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100430</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEICOPLANIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100416</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANIPENEM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100507</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICAFUNGIN SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100514</drugenddate>
        <drugtreatmentduration>61</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOTAL BODY RADIATION THERAPY</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100427</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141811-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-740639</companynumb>
    <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>EYELID MARGIN CRUSTING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ONYCHOMADESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>REDUCED DOSE.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141812-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ROCHE-743143</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
        <drugauthorizationnumb>017581</drugauthorizationnumb>
        <drugdosagetext>REPORTED AS NAPROSYN HIGH DOSE (} 220 MG): 750 MGD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DYGRATYL</medicinalproduct>
        <drugdosagetext>REPORTED AS DYGRATYL TABL 0.2 MGD. DOSE: 0.4 MGD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOPARATHYROIDISM</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAXIN TABLETS</medicinalproduct>
        <drugdosagetext>REPORTED AS LEVAXIN TABL 75 MIKROG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>REPORTED AS PANODIL FORTE FC</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141813-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-743476</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLANAX</medicinalproduct>
        <drugauthorizationnumb>018164</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE, FORM: FILM COATED TABLET</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141814-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MESTINON</medicinalproduct>
        <drugbatchnumb>OC1401</drugbatchnumb>
        <drugdosagetext>MESTINON 180 MG TIMESPAN QHS ORALLY; MESTINON 180 MG TIMESPAN 1/2 TAB 1400 ORALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYASTHENIA GRAVIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAMMAGARD</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141815-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ROCHE-743839</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VESANOID</medicinalproduct>
        <drugauthorizationnumb>020438</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZAVEDOS</medicinalproduct>
        <drugdosagetext>FREQUENCY: EVERY OTHER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101011</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141816-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010149489</companynumb>
    <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>ADVIL</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141817-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010149712</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>63.492</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugbatchnumb>E57949</drugbatchnumb>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>1 TAB, EVERY 4-6 HOURS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141818-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010148444</companynumb>
    <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</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141819-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010149405</companynumb>
    <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>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141820-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010149645</companynumb>
    <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 ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141821-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010156113</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>
      <patientweight>90.71</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugbatchnumb>E73035</drugbatchnumb>
        <drugauthorizationnumb>020402</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EAR PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101108</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN-D</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugdosagetext>400 MG, UNK</drugdosagetext>
        <drugindication>EAR INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141822-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010149502</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>181.41</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141823-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ROCHE-744399</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141824-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-744528</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>41</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN URINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBULOINTERSTITIAL NEPHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>ACTION TAKEN: DISCONTINUED</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100803</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100810</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100713</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100518</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100713</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
        <drugdosagetext>DOSAGE UNCERTAIN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugdosagetext>DOSAGE UNCERTAIN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MANNITOL</medicinalproduct>
        <drugdosagetext>DOSAGE UNCERTAIN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
        <drugdosagetext>DOSAGE UNCERTAIN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHYTHMY</medicinalproduct>
        <drugdosagetext>DOSAGE UNCERTAIN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED DRUG</medicinalproduct>
        <drugdosagetext>DOSAGE UNCERTAIN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141825-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJCH-2010027343</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>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXTROMETHORPHAN HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>TEXT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141826-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-745499</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>FORM: INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101027</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141827-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050218</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-745628</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>FUZEON</medicinalproduct>
        <drugauthorizationnumb>021481</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141828-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA79858</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100906</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141829-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010VE80424</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</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>PROSTHESIS IMPLANTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5MG/YEAR</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141830-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-ROCHE-745655</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACANTHOSIS NIGRICANS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CALCINOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEILITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLBLAINS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENURESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA NODOSUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOLLICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FURUNCLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES SIMPLEX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HORDEOLUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPETIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTIOUS MONONUCLEOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPIDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYCYTHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYDIPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PTERYGIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN FRAGILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DELAYED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOTRETINOIN</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SKIN DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141831-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-744028</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONGENITAL CENTRAL NERVOUS SYSTEM ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL DRUGS AFFECTING FOETUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACUTAN</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141832-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010IT80352</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>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091005</drugenddate>
        <drugtreatmentduration>215</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>1 TIMES PER WEEK</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091008</drugenddate>
        <drugtreatmentduration>218</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>2 TIMES PER WEEK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100906</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>1 TIMES PER WEEK</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091008</drugenddate>
        <drugtreatmentduration>218</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141833-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2008US07076</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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATOPHYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ICHTHYOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL FUNCTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KYPHOSCOLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTATIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ONYCHOMYCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROANTRAL FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIODONTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHYSICAL DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYNEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH VESICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SACROILIITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN FISSURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLOLISTHESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTEBRAL WEDGING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061030</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugdosagetext>2.5 MG / QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>1 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>1000 MCG / 1 X MONTH</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>100 MG / QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE</medicinalproduct>
        <drugdosagetext>50 MG / HS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUETIAPINE FUMARATE</medicinalproduct>
        <drugdosagetext>25 MG / HS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CICLOPIROX</medicinalproduct>
        <drugdosagetext>UNK / DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE</medicinalproduct>
        <drugdosagetext>10 MG / QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>800 MG / TID PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND HYDROCODONE BITARTRATE</medicinalproduct>
        <drugdosagetext>5 MG/500 / Q4-6HRS PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>875 MG / BID</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141834-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>63.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugbatchnumb>HF33310</drugbatchnumb>
        <drugdosagetext>ONE TABLET TWICE DAILY 047 ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugbatchnumb>HF33310</drugbatchnumb>
        <drugdosagetext>ONE TABLET TWICE DAILY 047 ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRI-SPRINTEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141835-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010ZA75614</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING DRUNK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG/ 100 ML</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141836-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010IT76314</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JAW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, MONTHLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091006</drugenddate>
        <drugtreatmentduration>98</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugindication>METASTASES TO BONE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141837-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP58242</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERURICAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALISKIREN/AMOLODIPINE BESYLATE/HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>150 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALISKIREN/AMOLODIPINE BESYLATE/HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIN</medicinalproduct>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT CC</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100416</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT CC</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVALO KOWA</medicinalproduct>
        <drugdosagetext>1 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100721</drugenddate>
        <drugtreatmentduration>181</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141838-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP61645</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PUSTULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, PER ADMINISTRATION</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100803</drugenddate>
        <drugtreatmentduration>1132</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONEALFA</medicinalproduct>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPARA-CA</medicinalproduct>
        <drugdosagetext>1200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>180 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080321</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugdosagetext>8 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100409</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRRIGATING SOLUTIONS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLARICID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141839-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010DE80630</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugdosagetext>4.6 MG/24HR</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101123</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARGIN</medicinalproduct>
        <drugdosagetext>20-0-40</drugdosagetext>
        <drugindication>NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>150 MG, QD</drugdosagetext>
        <drugindication>NEURALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141840-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP80184</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>HYPOGAMMAGLOBULINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141841-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA80110</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG EVERY 06 MONTHS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101117</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141842-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010FR71031</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN PLAQUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugdosagetext>4.6 MG/24HR</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STALEVO 100</medicinalproduct>
        <drugdosagetext>2 DF DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATHYMIL</medicinalproduct>
        <drugdosagetext>1 DF DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugdosagetext>1 DF DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugdosagetext>1 DF DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARDEGIC</medicinalproduct>
        <drugdosagetext>1 DF DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141843-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010KR80317</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091202</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141844-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ROCHE-744799</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141845-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-744803</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BILE DUCT OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASTUZUMAB</medicinalproduct>
        <drugdosagetext>FORM: INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASTUZUMAB</medicinalproduct>
        <drugdosagetext>DOSAGE ADMINISTRATION ERROR</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASTUZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141846-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CN77038</companynumb>
    <primarysource>
      <reportercountry>CHINA</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>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOGLOBIN BLOOD INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TROPONIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEBIVO</medicinalproduct>
        <drugauthorizationnumb>022011</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141847-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010NL82472</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG (1X PER 8 WEEKS), ADMINISTERED WITH NACL 0.9% 100 ML BAG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG (1X PER 8 WEEKS), ADMINISTERED WITH NACL 0.9% 100 ML BAG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141848-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US82673</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>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141849-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010DE71737</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAND FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTAVIA</medicinalproduct>
        <drugdosagetext>250 UG/ML, 1 ML</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141850-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010FR81974</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>10 MG, FOR 3 MONTHS</drugdosagetext>
        <drugindication>RENAL CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141851-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010NL82218</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS ANTILLES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG/5 ML EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100331</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141852-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>77.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT SUBSTITUTION ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NADOLOL</medicinalproduct>
        <drugbatchnumb>Z-4237</drugbatchnumb>
        <drugdosagetext>80 MG ONCE A DAY</drugdosagetext>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101021</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141853-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA61986</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PHOSPHORUS INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG EVERY FOUR WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091112</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141854-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR37975</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL TUBE INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STALEVO 100</medicinalproduct>
        <drugauthorizationnumb>021485</drugauthorizationnumb>
        <drugdosagetext>100/25/200MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROLOPA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141855-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010PL56985</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.66</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL DYSGENESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSMORPHISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR SKILLS IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKULL MALFORMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugauthorizationnumb>021014</drugauthorizationnumb>
        <drugdosagetext>MATERNAL DOSE WAS 300 MG PER DAY</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141856-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP81242</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141857-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR37963</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STALEVO 100</medicinalproduct>
        <drugauthorizationnumb>021485</drugauthorizationnumb>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
        <drugdosagetext>2 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TREMOR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBIDOPA + LEVODOPA</medicinalproduct>
        <drugdosagetext>0.5 MG, 5 TIMES DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141858-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ROCHE-744808</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIODONTAL DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASTUZUMAB</medicinalproduct>
        <drugdosagetext>FORM: VIALS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>DOSE LEVEL: 15 MG/KG, FORM: VIALS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>DOSE LEVEL: 6 AUC, FORM: VIALS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>DOSE LEVEL: 75 MG/M2, FORM: VIALS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101019</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141859-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-745038</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>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOCAL SEGMENTAL GLOMERULOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugdosagetext>NOTE: DOSAGE IS UNCERTAIN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugdosagetext>NOTE: DOSAGE IS UNCERTAIN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>NOTE: DOSAGE IS UNCERTAIN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BASILIXIMAB</medicinalproduct>
        <drugdosagetext>NOTE: DOSAGE IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141860-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC.-2010-RO-01450RO</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugbatchnumb>064023A</drugbatchnumb>
        <drugauthorizationnumb>017812</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101030</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugindication>SEASONAL ALLERGY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugindication>SEASONAL ALLERGY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141861-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BR-02802BR</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENSINA</medicinalproduct>
        <drugauthorizationnumb>017407</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141862-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13744BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>004047A,0C2202</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141863-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-12821BP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <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>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101113</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141864-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-745048</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>30</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141865-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ROCHE-745212</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANASTOMOTIC LEAK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOPHLEBITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141866-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-745422</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>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugdosagetext>DATE OF LAST DOSE PRIOR TO SAE:DECEMBER 2009.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugdosagetext>CORE STUDY:MA21573</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100804</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-DYDRAMOL</medicinalproduct>
        <drugdosagetext>STRENGTH:8/500</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080130</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141867-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033835</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>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMODULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141868-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ROCHE-745507</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>FREQUENCY: CYCLIC.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141869-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-745670</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugdosagetext>FORM: INFUSIONS. THE PATIENT RECEIVED FIVE INFUSIONS.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141870-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ROCHE-745684</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASTUZUMAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141871-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH029232</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>ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141872-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ROCHE-745778</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AUTONOMIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugauthorizationnumb>050585</drugauthorizationnumb>
        <drugdosagetext>DOSE: 1 GR, FREQUENCY: TOTAL</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CANRENOATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOTALIP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141873-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090317</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-745842</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141875-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-AVENTIS-2010SA071689</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>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021144</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100902</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100825</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPECIAFOLDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CACIT D3</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOPRAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOLIPRANE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100825</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141876-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-745962</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugauthorizationnumb>017533</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>POST-TRAUMATIC STRESS DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugauthorizationnumb>017533</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141877-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-745979</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081126</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090302</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090302</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOVORIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081126</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOVORIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOVORIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090302</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>5-FU</medicinalproduct>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081126</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>5-FU</medicinalproduct>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>5-FU</medicinalproduct>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>5-FU</medicinalproduct>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>5-FU</medicinalproduct>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090302</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>5-FU</medicinalproduct>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090302</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELPLAT</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081126</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELPLAT</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELPLAT</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090302</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090302</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141878-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-746030</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
        <drugauthorizationnumb>020239</drugauthorizationnumb>
        <drugdosagetext>FORM: INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZANTAC</medicinalproduct>
        <drugdosagetext>STRENGTH: 50 MG/2ML, 50 MG ADMINISTERED OCCASIONALLY BEFORE CHEMOTHERAPY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugdosagetext>80 MG ADMINISTERED OCCASIONALLY BEFORE CHEMOTHERAPY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL</medicinalproduct>
        <drugdosagetext>DOSAGE REGIMEN: HALF-0-HALF</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141879-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-746042</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100709</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISEDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>DRUG NAME:TEVA-RISEDORNETE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE PLUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN A</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>B COMPLEX 100</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141880-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-746056</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141881-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-GENZYME-POMP-1001237</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>MYOZYME</medicinalproduct>
        <drugindication>GLYCOGEN STORAGE DISEASE TYPE II</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141882-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-ROCHE-744294</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugdosagetext>FREQUENCY: DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100923</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141883-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-746094</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141884-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BAXTER-2010BH020045</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE BONE MARROW APLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HOLOXAN BAXTER</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HOLOXAN BAXTER</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HOLOXAN BAXTER</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080826</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HOLOXAN BAXTER</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080806</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UROMITEXAN BAXTER</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UROMITEXAN BAXTER</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UROMITEXAN BAXTER</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080826</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UROMITEXAN BAXTER</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080806</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080804</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN GENERIC</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN GENERIC</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080825</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN GENERIC</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080804</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPHREN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081115</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141885-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ROCHE-746237</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>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141886-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US64827</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THOUGHT BLOCKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTAVIA</medicinalproduct>
        <drugdosagetext>0.25 MG (1 ML), QOD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS NOS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MULTIPLE SCLEROSIS RELAPSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141887-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US76915</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD SMEAR TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTAVIA</medicinalproduct>
        <drugdosagetext>UNK, QOD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D3</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141888-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090324</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-746272</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>MAINTENANCE THERAPY PHASE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141889-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20081029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-746318</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141890-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GIANVI TEVA PHARMACEUTICALS</medicinalproduct>
        <drugbatchnumb>316353</drugbatchnumb>
        <drugdosagetext>1 TABLET DAILY BY MOUTH</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENORRHAGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NECON</medicinalproduct>
        <drugbatchnumb>314569A</drugbatchnumb>
        <drugdosagetext>1 TABLET DAILY BY MOUTH</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENORRHAGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101007</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141891-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80.7403</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISTERINE VANILLA MINT 1 LITER</medicinalproduct>
        <drugbatchnumb>2069LZ</drugbatchnumb>
        <drugdosagetext>MOUTH FULL MONDAY; MOUTH FULL TUESDAY</drugdosagetext>
        <drugindication>DENTAL DISORDER PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISTERINE VANILLA MINT 1 LITER</medicinalproduct>
        <drugbatchnumb>2069LZ</drugbatchnumb>
        <drugdosagetext>MOUTH FULL MONDAY; MOUTH FULL TUESDAY</drugdosagetext>
        <drugindication>DENTAL DISORDER PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101012</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141893-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-ROCHE-746397</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</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>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021858</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101109</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141895-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-746123</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>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACUTAN</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>20 MG EVERY OTHER DAY FOR THREE MONTHS IN A YEAR</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACUTAN</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>20 MG EVERY OTHER DAY FOR THREE MONTHS IN A YEAR</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141896-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-GENZYME-POMP-1001236</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>MYOZYME</medicinalproduct>
        <drugindication>GLYCOGEN STORAGE DISEASE TYPE II</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141898-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090401</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-746166</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONTRALATERAL BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141899-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040818</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-746315</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141900-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040929</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-746339</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>5</qualification>
    </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>ROUTE REPORTED AS INJECTION</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141901-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-744012</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugauthorizationnumb>017533</drugauthorizationnumb>
        <drugdosagetext>FORM: PILLS; INDICATION REPORTED AS ^ANXIUOS, ETC.^</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugauthorizationnumb>017533</drugauthorizationnumb>
        <drugdosagetext>OVERDOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141904-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101020</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0889318A</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>
      <patientweight>108.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OFATUMUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101013</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLORAZEPATE DIPOTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141905-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687750A</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OFATUMUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENDAMUSTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141907-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57.1532</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CASTLEMAN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugdosagetext>90 MG ONCE T_____ SQ ; 90 MG 4 WEEKS TOTAL</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugdosagetext>90 MG ONCE T_____ SQ ; 90 MG 4 WEEKS TOTAL</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141909-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>23.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugbatchnumb>NOT KNOWN</drugbatchnumb>
        <drugdosagetext>20 MG DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100322</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141911-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101200454</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>96</patientweight>
      <patientsex>1</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>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141912-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-JNJFOC-20101108950</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</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>BACTERIAL TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ONYCHOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN CHAPPED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>POLYARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141913-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-BAXTER-2010BH029164</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE MALFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>INGUINAL HERNIA REPAIR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETAMINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCOPYRROLATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENFLURANE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATRACURIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROUS OXIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>MAINTENANCE OF ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141914-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.3075</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARRI</medicinalproduct>
        <drugbatchnumb>00555-9043-58</drugbatchnumb>
        <drugdosagetext>1 PER DAY</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100816</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARRI</medicinalproduct>
        <drugbatchnumb>00555-9043-58</drugbatchnumb>
        <drugdosagetext>1 PER DAY</drugdosagetext>
        <drugindication>DYSMENORRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100816</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141915-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-03P-087-0221974-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBILIRUBINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021226</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060313</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020945</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090923</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020926</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020926</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATAZANAVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090923</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050328</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECOBALAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCIATICA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060802</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECOBALAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RALTEGRAVIR</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 800 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090924</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090924</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141916-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA-2010-0050930</companynumb>
    <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>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022272</drugauthorizationnumb>
        <drugdosagetext>80 MG, UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>7.5 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141917-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033537</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091225</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141920-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATRIPLA</medicinalproduct>
        <drugdosagetext>EFV 600 MG PO QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTROPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTAZAPEM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141922-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>82.5547</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugdosagetext>400 MG 1 A DAY</drugdosagetext>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101012</drugstartdate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugdosagetext>400 MG 1 A DAY</drugdosagetext>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101012</drugstartdate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141923-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897902A</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>APPLICATION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugbatchnumb>1005094</drugbatchnumb>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101205</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141924-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897965A</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 LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERUCTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLI</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021887</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WEIGHT LOSS DIET</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLONIC CLEANSER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141925-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0679506A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>100</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIQUITIN CQ 4MG LOZENGE</medicinalproduct>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101010</drugenddate>
        <drugtreatmentduration>70</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141926-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20091103634</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>
      <patientweight>97</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050421</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICHEW</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141927-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NAPPMUNDI-USA-2010-0056202</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>40 MG, TID</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141928-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA-2010-0056335</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022272</drugauthorizationnumb>
        <drugdosagetext>80 MG, TID</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROXICODONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>30 MG, PRN</drugdosagetext>
        <drugindication>BREAKTHROUGH PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROXICODONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>15 MG, PRN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141929-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>93.8946</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>750 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141931-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>24.9478</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRODUCT SUBSTITUTION ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>30 MG DAILY G-TUBE</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141933-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.1834</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>ONCE DAILY 047 (ORAL)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETIC NEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141936-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006902</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>ENBREL</medicinalproduct>
        <drugdosagetext>UNK UNK, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141937-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AMGEN-DEUNI2010003306</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HLA MARKER STUDY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HLA MARKER STUDY POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARBEPOETIN ALFA</medicinalproduct>
        <drugdosagetext>15 A?G, QWK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYSTEINE</medicinalproduct>
        <drugdosagetext>180 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BICANORM                           /00049401/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCALTROL</medicinalproduct>
        <drugdosagetext>0.25 A?G, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>1200 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>100 A?G, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM ACETATE</medicinalproduct>
        <drugdosagetext>1 G, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GONATROPIN</medicinalproduct>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERRLECIT                          /00345601/</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141938-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201041496NA</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>MULTIPLE INJURIES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE + ETHINYLESTRADIOL 20A?G (24+4)</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141939-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-FRASP2010004880</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPARATHYROIDISM SECONDARY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141940-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010007068</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PERIPHERAL SENSORY NEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141941-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010000370</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>APLASTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141942-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010001205</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100723</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141943-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13674BP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141944-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NAPPMUNDI-USA-2010-0055007</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>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>W8H01</drugbatchnumb>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>120 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MEDICAL DEVICE PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141945-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NAPPMUNDI-USA-2010-0051801</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022272</drugauthorizationnumb>
        <drugdosagetext>10 MG, Q12H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101028</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN/TAXOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK NG/ML, UNK</drugdosagetext>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141946-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2010SE56197</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25320</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPRIVAN</medicinalproduct>
        <drugauthorizationnumb>019627</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101029</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>6 COURSE.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SKENAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101031</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIMBEX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101029</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIPARINE</medicinalproduct>
        <drugdosagetext>5000IU/0.2 ML.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL PANPHARMA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101031</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPIFEN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101031</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFUROXIME PANPHARMA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101029</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXEN</medicinalproduct>
        <drugdosagetext>LONG LASTING.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROX</medicinalproduct>
        <drugdosagetext>LONG LASTING.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOCTRAN</medicinalproduct>
        <drugdosagetext>LONG LASTING.</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141948-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-SANOFI-AVENTIS-2010SA031188</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLOSTAR</medicinalproduct>
        <drugbatchnumb>C702</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141949-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033719</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 FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100119</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141950-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-CEPHALON-2010006155</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TREANDA</medicinalproduct>
        <drugauthorizationnumb>022249</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050112</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050112</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141951-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ABBOTT-10P-013-0655979-00</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100320</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141952-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0662872A</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>ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVELOPMENTAL DELAY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSMORPHISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT ATRIAL DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE CONGENITAL ABNORMALITIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER DEVELOPMENTAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010125</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>P-EPHED/CPM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOXACILLIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GUAIFED</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010218</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMOX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010219</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000219</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
        <drugindication>PREGNANCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOTRIMAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141953-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0680198A</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>AORTIC STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COARCTATION OF THE AORTA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSISTENT FOETAL CIRCULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHONE COMPLEX</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141954-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0680222A</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</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL AORTIC ATRESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GROWTH RETARDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPLASTIC LEFT HEART SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE ATRESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugindication>PANIC ATTACK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141955-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0681514A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL APLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UMBILICAL CORD ABNORMALITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VESICOURETERIC REFLUX</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugauthorizationnumb>020936</drugauthorizationnumb>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SALICYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCARDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIORICET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141956-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0681518A</companynumb>
    <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 EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRABISMUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141957-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0685997A</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>ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COARCTATION OF THE AORTA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART DISEASE CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141958-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0687272A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>1.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION VENTRICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBILIRUBINAEMIA NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPLASTIC LEFT HEART SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPLASTIC RIGHT HEART SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFANTILE APNOEIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATENT DUCTUS ARTERIOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERY STENOSIS CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY VALVE STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141959-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0699224A</companynumb>
    <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>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID OVERLOAD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIGHT VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141960-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0743809A</companynumb>
    <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>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060925</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141961-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0756641A</companynumb>
    <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>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MACROBID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000506</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141962-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0783973A</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL VASCULAR DISORDER</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>20010501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141963-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0790842A</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>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE MALEATE</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141964-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0793839A</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>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141965-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0803360A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051022</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141966-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0803362A</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>127.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141967-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0803365A</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>72.7</patientweight>
      <patientsex>2</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141968-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0803366A</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>
      <patientweight>143.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOTHORAX</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>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141969-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0803367A</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>
      <patientweight>89.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141970-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0803368A</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>
      <patientweight>75.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061114</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141971-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0803369A</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>
      <patientweight>109.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGESTIVE CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000217</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141972-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0803556A</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000305</drugenddate>
        <drugtreatmentduration>430</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141973-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0803640A</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>110</patientweight>
      <patientsex>1</patientsex>
      <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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141974-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0803830A</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070515</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141975-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0803854A</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141976-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0804106A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030529</drugenddate>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141977-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0804107A</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>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</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>20041130</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141978-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0804112A</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>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141979-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0804115A</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141980-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0804180A</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>CARDIO-RESPIRATORY ARREST</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>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141981-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0847410A</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>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL HYDROCEPHALUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRANIOSYNOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIC-ISCHAEMIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICROCEPHALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY VALVE STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TALIPES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMIG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIRTH CONTROL PILL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACEBUTOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141982-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0848928A</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>CEREBROVASCULAR ACCIDENT</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>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141983-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>POOR QUALITY DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>1014359</drugbatchnumb>
        <drugdosagetext>8,000 UNITS 2 TIMES A WEEK HEMODIALYSIS</drugdosagetext>
        <drugadministrationroute>010</drugadministrationroute>
        <drugindication>HAEMATOCRIT ABNORMAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141984-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0848929A</companynumb>
    <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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERIAL STENT INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</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>7141985-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0848930A</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>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070404</drugenddate>
        <drugtreatmentduration>755</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141986-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0848933A</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>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</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>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070713</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141987-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0848938A</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>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL INJURY</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>20010928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070322</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141988-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0848944A</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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141989-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0848976A</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR GRAFT</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>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051215</drugenddate>
        <drugtreatmentduration>413</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141990-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0848990A</companynumb>
    <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 DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060821</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141991-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0849257A</companynumb>
    <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>RENAL VESSEL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR GRAFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS OCCLUSION</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>20010615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141992-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0849270A</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>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090921</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141993-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0849348A</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>BLADDER CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141994-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0861789A</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>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <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>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141995-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0863082A</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>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INHALATION THERAPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENSIVE CARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLIATIVE CARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY THERAPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
        <drugauthorizationnumb>021319</drugauthorizationnumb>
        <drugindication>PROSTATOMEGALY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugauthorizationnumb>020983</drugauthorizationnumb>
        <drugindication>EMPHYSEMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141996-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0863577A</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>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARONYCHIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN CHAPPED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYKERB</medicinalproduct>
        <drugbatchnumb>R48438</drugbatchnumb>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugdosagetext>1250MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141997-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0863742A</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>CARDIAC DISORDER</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>19990501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141998-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0863801A</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7141999-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0864886A</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC PACEMAKER INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</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>20050802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142000-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0869273A</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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID OVERLOAD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142001-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0871543A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142002-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0871954A</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>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142003-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0874957A</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMEMBRANOUS COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFUROXIME</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050605</drugauthorizationnumb>
        <drugdosagetext>500MG PER DAY</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100721</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE 0.9%</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100721</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142004-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0875869A</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STENT PLACEMENT</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>20000508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070821</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142005-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0875878A</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>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</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>20030109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060726</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142006-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0882153A</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>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142007-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0882174A</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090202</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142008-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0882176A</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>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142009-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0882178A</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142010-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0882179A</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142011-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0882762A</companynumb>
    <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 BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES PALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOTRIENT</medicinalproduct>
        <drugbatchnumb>UNKNOWN,0173-0804-09</drugbatchnumb>
        <drugauthorizationnumb>022465</drugauthorizationnumb>
        <drugdosagetext>800MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100920</drugenddate>
        <drugtreatmentduration>143</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142012-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0882795A</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>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL VEIN OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142013-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0882803A</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>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142014-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0882806A</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>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142015-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0882809A</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>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDARYL</medicinalproduct>
        <drugauthorizationnumb>021700</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142016-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0882976A</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>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142017-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0882979A</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>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142018-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0885982A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>95</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROMACTA</medicinalproduct>
        <drugauthorizationnumb>022291</drugauthorizationnumb>
        <drugdosagetext>75MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100826</drugenddate>
        <drugtreatmentduration>46</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROMIPLOSTIM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142019-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0890884A</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugdosagetext>2PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020405</drugauthorizationnumb>
        <drugdosagetext>125MCG UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEART RATE INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMETANIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142020-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0891300A</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>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>QUALITY OF LIFE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>BRONCHIECTASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142021-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0892040A</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>63.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY CHANGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022115</drugauthorizationnumb>
        <drugdosagetext>200MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100603</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142022-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0892687A</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEPRON</medicinalproduct>
        <drugbatchnumb>0B002</drugbatchnumb>
        <drugauthorizationnumb>020500</drugauthorizationnumb>
        <drugdosagetext>5ML TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADERM</medicinalproduct>
        <drugdosagetext>100MCG TWO TIMES PER WEEK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIV TREATMENTS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142023-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0892922A</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>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugbatchnumb>0ZP3851</drugbatchnumb>
        <drugauthorizationnumb>020983</drugauthorizationnumb>
        <drugdosagetext>2PUFF SIX TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090911</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142024-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0896732A</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>ADENOCARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugbatchnumb>0135A</drugbatchnumb>
        <drugauthorizationnumb>021345</drugauthorizationnumb>
        <drugdosagetext>1INJ PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142025-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0896736A</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>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugbatchnumb>[NOT ENTERED]</drugbatchnumb>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142026-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0896970A</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 ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF-MEDICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>30TAB SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142027-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0896979A</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>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-CARDIAC CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRAUMATIC LUNG INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugbatchnumb>0ZP9431</drugbatchnumb>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>EMPHYSEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUONEB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVENTIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXCEDRIN (MIGRAINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED YEAST RICE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALAVERT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142028-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897212A</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>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugbatchnumb>0ZP7291</drugbatchnumb>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTASIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUSSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLDOPA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLERGY INJECTION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142029-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897416A</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVEDO RETICULARIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERMAL BURN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN SR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020358</drugauthorizationnumb>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101115</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARMOUR THYROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPLIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142030-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897510A</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>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROMACTA</medicinalproduct>
        <drugauthorizationnumb>022291</drugauthorizationnumb>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142031-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897832A</companynumb>
    <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>INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142032-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897833A</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>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142033-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897977A</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
        <drugindication>SINUSITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142034-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0898148A</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>67.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
        <drugbatchnumb>146-180172</drugbatchnumb>
        <drugauthorizationnumb>020207</drugauthorizationnumb>
        <drugdosagetext>336MG SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101025</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142035-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0898151A</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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>150MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100721</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142036-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0597410A</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>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAESTHETIC COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVE BIRTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE LABOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS RHYTHM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugauthorizationnumb>020405</drugauthorizationnumb>
        <drugdosagetext>.125MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUCCINYLCHOLINE CHLORIDE</medicinalproduct>
        <drugdosagetext>120MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
        <drugdosagetext>20MGML PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPHEDRINE</medicinalproduct>
        <drugdosagetext>5UGML PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RINGERS SOLUTION</medicinalproduct>
        <drugdosagetext>500ML PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>100UG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYLEPHRINE HCL</medicinalproduct>
        <drugdosagetext>100UG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THIOPENTAL SODIUM</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIURETICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142037-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0645028A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>22</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARRANON</medicinalproduct>
        <drugauthorizationnumb>021877</drugauthorizationnumb>
        <drugdosagetext>650MGM2 PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091114</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091121</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYLOCIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091121</drugenddate>
        <drugtreatmentduration>79</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VEPESID</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091121</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUNASE</medicinalproduct>
        <drugdosagetext>21000IU PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091031</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUNGUARD</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FIRSTCIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUKERIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091001</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENDOXAN</medicinalproduct>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090904</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENDOXAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090918</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090904</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090918</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090928</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAXIZON</medicinalproduct>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090904</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAXIZON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090918</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAKTAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100111</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUVELA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100111</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUQUINON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100111</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KANAMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100111</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLYMYXIN-B-SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100111</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100111</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142038-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0662101A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>CHEST X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERY WALL HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY VEIN OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY VENO-OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
        <drugauthorizationnumb>020444</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142039-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0669934A</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</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>TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILATREND</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext>250MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZBROMARONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODIOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOSARTAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142040-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0676797A</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>96.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
        <drugauthorizationnumb>014691</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090924</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>195MG PER DAY</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090924</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100819</drugenddate>
        <drugtreatmentduration>330</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100623</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>.125MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100622</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142041-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0677418A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEFIX</medicinalproduct>
        <drugauthorizationnumb>021003</drugauthorizationnumb>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050325</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYCOBAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADETPHOS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142042-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0680231A</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 EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugauthorizationnumb>019910</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091224</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOPINAVIR/RITONAVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100715</drugenddate>
        <drugtreatmentduration>386</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABACAVIR SULFATE/LAMIVUDINE</medicinalproduct>
        <drugauthorizationnumb>021652</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100715</drugenddate>
        <drugtreatmentduration>386</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugauthorizationnumb>019655</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091113</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142043-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0683264A</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugbatchnumb>8190</drugbatchnumb>
        <drugauthorizationnumb>020983</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142044-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0684740A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugauthorizationnumb>020207</drugauthorizationnumb>
        <drugdosagetext>220MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100306</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VEPESID</medicinalproduct>
        <drugdosagetext>850MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100305</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENDOXAN</medicinalproduct>
        <drugdosagetext>4260MG PER DAY</drugdosagetext>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100304</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE SODIUM PHOSPHATE</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100306</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugdosagetext>700MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100302</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUTROGIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100321</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UROMITEXAN</medicinalproduct>
        <drugdosagetext>5100MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100304</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100308</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAXIZON</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100308</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAXIZON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100310</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIDOL</medicinalproduct>
        <drugdosagetext>125MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100308</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITRIZOLE</medicinalproduct>
        <drugdosagetext>20ML PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100609</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TETRAMIDE</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100609</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugdosagetext>.25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100609</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALONAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100331</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100609</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142045-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0685247A</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIC SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORAMBUCIL</medicinalproduct>
        <drugauthorizationnumb>010669</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100617</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142046-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0686710A</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBODART</medicinalproduct>
        <drugauthorizationnumb>022460</drugauthorizationnumb>
        <drugdosagetext>1CAP PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101122</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TELMISARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142047-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0686834A</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>44</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYVERB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugdosagetext>1250MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugdosagetext>2300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101013</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142048-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0686835A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugauthorizationnumb>019655</drugauthorizationnumb>
        <drugdosagetext>500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COTRIM</medicinalproduct>
        <drugdosagetext>1IUAX PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVELAMER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLIZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142049-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0686974A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSAL ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142050-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687173A</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>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugbatchnumb>0793/001</drugbatchnumb>
        <drugauthorizationnumb>018473</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142051-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687235A</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>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL CHANGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142052-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687253A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugauthorizationnumb>021345</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142053-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687485A</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>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSLALIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <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>20101127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101129</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142054-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687598A</companynumb>
    <primarysource>
      <reportercountry>RUSSIAN FEDERATION</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>ENTEROCOLITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC DIATHESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYVERB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142055-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687609A</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>022251</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142056-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040601</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687623A</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILATREND</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142057-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060906</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687627A</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>DILATREND</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142058-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687674A</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>LIP OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN</medicinalproduct>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101106</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142059-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687676A</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL BELOW THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILATREND</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142060-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687679A</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOMICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MALARONE</medicinalproduct>
        <drugauthorizationnumb>021078</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142061-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687724A</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILATREND</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142062-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687726A</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN</medicinalproduct>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TOOTHACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101115</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142063-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060320</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687727A</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>DILATREND</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142064-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687728A</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN</medicinalproduct>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101003</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142065-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040519</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687733A</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILATREND</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142066-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687735A</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</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>DILATREND</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142067-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687742A</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE III IMMUNE COMPLEX MEDIATED REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLAMOXYL</medicinalproduct>
        <drugauthorizationnumb>050542</drugauthorizationnumb>
        <drugdosagetext>2G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142068-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687749A</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILATREND</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142069-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060808</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687763A</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>DILATREND</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142070-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060607</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687766A</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILATREND</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142071-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040603</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687773A</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RHINITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILATREND</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142072-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687776A</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>DILATREND</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142073-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040715</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687784A</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILATREND</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142074-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687797A</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>JAUNDICE CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN</medicinalproduct>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101104</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142075-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687798A</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugauthorizationnumb>020007</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101125</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142076-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687800A</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTIN</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142077-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687801A</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE I HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugauthorizationnumb>020007</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAVANIC</medicinalproduct>
        <drugdosagetext>500MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOMYELITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEXANE</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOXAPEN</medicinalproduct>
        <drugdosagetext>2G FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOMYELITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIMACTANE</medicinalproduct>
        <drugdosagetext>450MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AUTOIMMUNE HEPATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MODURETIC 5-50</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOCALISED OEDEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOCALISED OEDEMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142078-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7029832</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>FEMORAL ARTERY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORAL BIRTH CONTROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142079-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-FRASP2010004884</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPARATHYROIDISM SECONDARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142080-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-JPNCT2010005057</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>
      <reaction>
        <reactionmeddrapt>DERMATITIS ACNEIFORM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANITUMUMAB</medicinalproduct>
        <drugdosagetext>6 MG/KG, Q2WK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100927</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANITUMUMAB</medicinalproduct>
        <drugdosagetext>6 MG/KG, Q2WK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101025</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMITT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUFAST</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142081-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101128</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-FR-WYE-G01573108</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAIR TEXTURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PLAQUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMESTA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERCIAN</medicinalproduct>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYSANXIA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142082-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-HQWYE804015OCT04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>0.625MG/2.5MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19950101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19950101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142083-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010158591</companynumb>
    <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>PROTONIX</medicinalproduct>
        <drugauthorizationnumb>020987</drugauthorizationnumb>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142084-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-PFIZER INC-2006101253</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>12-400 MG TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>4800 MG, 1 IN 1 TOTAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>26-500 MG TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>13000 MG, 1 IN 1 TOTAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILAZEP DIHYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>8-5 MG TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPHENIDATE</medicinalproduct>
        <drugdosagetext>28 DOSE(S), 1 IN 1 TOTAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
        <drugdosagetext>6-8 UNITS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142085-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-HQWYE353521JUL05</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>ONCE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ONCE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19950101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>ONCE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19950101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugdosagetext>0.1 MG, UNK</drugdosagetext>
        <drugindication>BLOOD PRESSURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugdosagetext>160-25 MG</drugdosagetext>
        <drugindication>BLOOD PRESSURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142086-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010095303</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>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>STARTING PAK</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLOOD DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLOOD DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLOOD DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLOOD DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLOOD DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLOOD DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142087-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010110115</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>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</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>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142088-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010163633</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>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142089-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2009315009</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>96</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PF-04383119</medicinalproduct>
        <drugdosagetext>Q 8 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100510</drugenddate>
        <drugtreatmentduration>169</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugauthorizationnumb>020402</drugauthorizationnumb>
        <drugdosagetext>400 MG, EVERY 4 HRS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091226</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTAZIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYQUIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091218</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142090-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2008US03405</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>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR SPINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCCULT BLOOD POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CAVITY FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYPECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>MONTHLY</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INTERFERON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT                            /00909301/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugdosagetext>5-500MG Q4 HRS PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONTELUKAST SODIUM</medicinalproduct>
        <drugdosagetext>1 TAB AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENICILLIN V POTASSIUM</medicinalproduct>
        <drugdosagetext>1 TAB Q8 HRS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERIDEX</medicinalproduct>
        <drugdosagetext>15CC FOR 30 SEC 3X QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>500MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>50MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORHEXIDINE GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142091-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US81001</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 SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTURNA</medicinalproduct>
        <drugauthorizationnumb>022217</drugauthorizationnumb>
        <drugdosagetext>300/320 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142092-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US02903</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>ACTINOMYCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHTHOUS STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED INTEREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCORIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLUCOSE TOLERANCE IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GROIN ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SPRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYNEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRIMARY SEQUESTRUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL CLAUDICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTEBRAL FORAMINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BONE NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060417</drugenddate>
        <drugtreatmentduration>107</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugindication>BONE DENSITY DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugdosagetext>10.8 MG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>0.5 MG, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>200 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICHLORMETHIAZIDE</medicinalproduct>
        <drugdosagetext>48 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRAPE SEED</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDODERM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERIDEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FASLODEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOMOTIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>37.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugdosagetext>0.5 MG, BID</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>20 MG, QW</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
        <drugdosagetext>50 MG, QW</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>20 MG, QW</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>1 G, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugdosagetext>500 MG, ONCE/SINGLE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
        <drugdosagetext>25 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HCL</medicinalproduct>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPINEPHRINE</medicinalproduct>
        <drugdosagetext>1 MG, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE SODIUM SUCCINATE</medicinalproduct>
        <drugdosagetext>100 MG, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAPTOMYCIN</medicinalproduct>
        <drugdosagetext>440 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN LISPRO</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
        <drugdosagetext>10 MG, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA-S (DOCUSATE SODIUM/SENNOSIDES)</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AROMASIN</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESIPRAMINE HCL</medicinalproduct>
        <drugdosagetext>10 MG, PRN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142093-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US11288</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS NECK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CENTRAL NERVOUS SYSTEM LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON ADENOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONOSCOPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED INTEREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOSCOPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL ARTERIOVENOUS MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL EROSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIFE EXPECTANCY SHORTENED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR SPINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN CELL HAEMOGLOBIN CONCENTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE ROOT LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETICULOCYTE COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEM CELL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTEBRAL FORAMINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugdosagetext>90 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>4MG / 5 TABLETS DAILY , FOR 5 DAYS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>50 MG / 1 TABLET EVERY NIGHT AT BEDTIME</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugdosagetext>50 MCG / INHALE 2 SPRAYS EACH NOSTRIL DAILY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORHEXIDINE GLUCONATE</medicinalproduct>
        <drugdosagetext>UNK / RINSE 1/2 OZ 2 X DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGIC MOUTHWASH</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>875 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugdosagetext>24 MG, DAILY FOR 3 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR SODIUM</medicinalproduct>
        <drugdosagetext>800 MG, Q12H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugdosagetext>250 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
        <drugdosagetext>50 MG, ONCE/SINGLE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
        <drugdosagetext>295 MG, ONCE/SINGLE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNASYN</medicinalproduct>
        <drugdosagetext>1.5 G, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNASYN</medicinalproduct>
        <drugdosagetext>3 G, Q6H</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugdosagetext>10 MG, Q 4 HOURS PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>80 MEQ, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOSYN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FILGRASTIM</medicinalproduct>
        <drugdosagetext>0.3 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFEPIME</medicinalproduct>
        <drugdosagetext>1 G, Q8H</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugdosagetext>8 MG, TID</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
        <drugdosagetext>500 MG, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEN-VEE K</medicinalproduct>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORADOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON DEXTRAN</medicinalproduct>
        <drugdosagetext>800 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT                            /00909301/</medicinalproduct>
        <drugindication>ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENICILLIN ^GRUNENTHAL^</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKELAXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RELAFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCORTOLONE VALERATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142094-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US80893</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG OD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TASIGNA</medicinalproduct>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101113</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142095-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2008PH06783</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070415</drugenddate>
        <drugtreatmentduration>375</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUNITINIB MALATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070613</drugenddate>
        <drugtreatmentduration>453</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLOSA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBANDRONIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE PLUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORIAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN AND MINERAL PRENATAL SUPPLEMENT W/ FOLIC ACID CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANSIMAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUIMICIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOSTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142096-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US11407</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER CATHETERISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICAL MYELOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED INTEREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPICONDYLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCESSIVE GRANULATION TISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIFE EXPECTANCY SHORTENED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROGENIC BLADDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROGENIC BOWEL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOLOGICAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAL BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL CORD COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLOLISTHESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYRINGOMYELIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DRAINAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT                            /00909301/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN ^LAPPE^</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENICILLIN VK</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERIDEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142097-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US04665</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.585</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADRENAL INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDICECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDICITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APTYALISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE EROSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE FRAGMENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COR PULMONALE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDODONTIC PROCEDURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESSENTIAL THROMBOCYTHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE LASER SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRODUODENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMANGIOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUMERUS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGAMMAGLOBULINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR SPINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALOCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTATIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELOPROLIFERATIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEITIS DEFORMANS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIODONTAL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIODONTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR DENTAL CONDITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULPITIS DENTAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCLERODERMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYMPANIC MEMBRANE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE ENLARGEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE LEIOMYOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS DETACHMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEGENER'S GRANULOMATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION STAPHYLOCOCCAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugdosagetext>3.125 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERIDEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>15 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugdosagetext>200 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>12.5 / QHS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BELLERGAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DONNATAL</medicinalproduct>
        <drugdosagetext>1 TAB, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
        <drugdosagetext>1200 MG, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugdosagetext>5-325 MG / PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugdosagetext>5 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMANTADINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugdosagetext>2 GM / QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugdosagetext>750 MCG / DAILY AM</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugdosagetext>8 MG / PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
        <drugdosagetext>900 MG / Q8</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INVANZ</medicinalproduct>
        <drugdosagetext>1 GM / DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANAGRELIDE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugdosagetext>30 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTIN</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALAGEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugdosagetext>7.5 MG, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRANDIN ^KUHN^</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDODERM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITONIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELCHOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOL MEDROL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAGAMET</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPRIVAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEFOXIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAMIMUNE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARBEPOETIN ALFA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOSTATIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEFZOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGELAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEOCIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXFORGE (VALSARTAN/AMLODIPINE BESILATE)</medicinalproduct>
        <drugdosagetext>5/320 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARAFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTROBAN                               /NET/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEFLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUDAFED 12 HOUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPECTAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEROCCA                                 /SCH/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEPHRO-VITE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAPLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOMOTIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMVIR                                  /NET/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AGRYLIN</medicinalproduct>
        <drugdosagetext>0.5 MG, BID</drugdosagetext>
        <drugindication>THROMBOCYTOPENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>2 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYCLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANZEMET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142098-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA-2010-0056254</companynumb>
    <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>MORPHINE SULFATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>15 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142099-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-10P-062-0689139-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARCOXIA</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 90 MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142100-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.6892</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HCL AND ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>100-650MGTEV AS NEEDED PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HCL AND ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>100-650MGTEV AS NEEDED PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HCL AND ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>100-650MGTEV AS NEEDED PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NECK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HCL AND ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>100-650MGTEV AS NEEDED PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101120</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142101-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMSIROLIMUS</medicinalproduct>
        <drugdosagetext>25 MG ONCE Q WK IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINORELBINE</medicinalproduct>
        <drugdosagetext>20 MG/M2 ONCE Q 2 WKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142103-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.6475</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTRAST MEDIA REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR OF DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF EMPLOYMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE INJURIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST-TRAUMATIC STRESS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNEVIST</medicinalproduct>
        <drugdosagetext>16CC IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAPHYLACTIC REACTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051230</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051230</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142104-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010149453</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>77.098</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL CONGESTION RELIEF</medicinalproduct>
        <drugbatchnumb>E80796</drugbatchnumb>
        <drugauthorizationnumb>022565</drugauthorizationnumb>
        <drugdosagetext>1 DF, SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUS HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101109</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142105-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010164003</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>019787</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142106-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010152402</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>81.633</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL CONGESTION RELIEF</medicinalproduct>
        <drugbatchnumb>E79507</drugbatchnumb>
        <drugauthorizationnumb>022565</drugauthorizationnumb>
        <drugdosagetext>1 CAPLET, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUS CONGESTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101111</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142107-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-US-WYE-H17844410</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>62.65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugbatchnumb>E75041</drugbatchnumb>
        <drugauthorizationnumb>020402</drugauthorizationnumb>
        <drugdosagetext>3 LIQUI-GELS AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONE-A-DAY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142108-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>68.9467</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugdosagetext>50/1000MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NTG PRN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RYTHMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142110-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>102.0593</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEMICAL POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TARDIVE DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19911001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142111-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-15419138</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>INITIAL DOSE:680MG RECENT DOSE:17NOV10</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEAD AND NECK CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101117</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>1DF=175 UNITS NS INITIAL DOSE:270 UNITS NS RECENT DOSE:17NOV10</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEAD AND NECK CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101117</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>1DF=56 UNITS NS INITIAL DOSE:54 UNITS NS RECENT DOSE:17NOV10</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEAD AND NECK CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101117</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>DOSE: 1-0-1/2</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142112-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-BRISTOL-MYERS SQUIBB COMPANY-15419203</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</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>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORENCIA</medicinalproduct>
        <drugdosagetext>3 DOSES</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>086358</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142113-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-BRISTOL-MYERS SQUIBB COMPANY-15335854</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>RECENT DOSE ON 01OCT10 NO.OF INF:8TH STRENGTH:5MG/ML</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEAD AND NECK CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100813</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>RECENT DOSE ON 1OCT10 NO.OF INF:3RD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEAD AND NECK CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100813</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>30JUL10-08OCT10(70DAYS) 3 IN 1 DAY 08OCT10-11OCT10(3DAYS) 8 IN 1 DAY</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CILENGITIDE</medicinalproduct>
        <drugdosagetext>RECENT DOSE ON 08OCT10  NO.OF INF:17TH</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEAD AND NECK CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100813</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>RECENT DOSE ON 01OCT10  NO.OF INF:3RD CONTINOUS INF FROM DAY 1 TO DAY 4 OF CYCLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEAD AND NECK CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100813</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142114-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-12542BP</companynumb>
    <primarysource>
      <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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC 150</medicinalproduct>
        <drugbatchnumb>A54022</drugbatchnumb>
        <drugauthorizationnumb>021698</drugauthorizationnumb>
        <drugdosagetext>600 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC 150</medicinalproduct>
        <drugbatchnumb>A54022</drugbatchnumb>
        <drugauthorizationnumb>021698</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142115-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13741BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>EMPHYSEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142116-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13639BP</companynumb>
    <primarysource>
      <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>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020884</drugauthorizationnumb>
        <drugdosagetext>25MG/200MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091229</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020884</drugauthorizationnumb>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142117-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-15013063</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>RECENT INF: 21DEC09</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>RECENT INF: 21DEC09</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>RECENT INF: 29DEC09</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>RECENT DOSE:24NOV09</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091124</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142118-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BR-02814BR</companynumb>
    <primarysource>
      <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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENSINA</medicinalproduct>
        <drugauthorizationnumb>017407</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142119-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-AVENTIS-2010SA055700</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEVICE MALFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLOSTAR</medicinalproduct>
        <drugbatchnumb>0F039A</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APIDRA SOLOSTAR</medicinalproduct>
        <drugbatchnumb>0F039A</drugbatchnumb>
        <drugauthorizationnumb>021629</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142120-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-15422405</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>ACUTE CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugauthorizationnumb>020357</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARDEGIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142121-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15403041</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>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONGLYZA</medicinalproduct>
        <drugauthorizationnumb>022350</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFONAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142122-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-15408818</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>11</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMMONIA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>90 MG/KG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>90 MG/KG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALAISE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>90 MG/KG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>90 MG/KG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VOMITING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugauthorizationnumb>061885</drugauthorizationnumb>
        <drugindication>PYREXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugauthorizationnumb>061885</drugauthorizationnumb>
        <drugindication>MALAISE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugauthorizationnumb>061885</drugauthorizationnumb>
        <drugindication>VOMITING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugauthorizationnumb>061885</drugauthorizationnumb>
        <drugindication>NAUSEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142123-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2010FR13317</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>AXONAL NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BEHCET'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBELLAR SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CSF PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE CONDUCTION STUDIES ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL CORD DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>065017</drugauthorizationnumb>
        <drugdosagetext>200 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHOROIDITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>065017</drugauthorizationnumb>
        <drugdosagetext>300MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INTERFERON ALFA-2A</medicinalproduct>
        <drugindication>BEHCET'S SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
        <drugindication>BEHCET'S SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>BEHCET'S SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142124-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2010TN13312</companynumb>
    <primarysource>
      <reportercountry>TUNISIA</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>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>076192</drugauthorizationnumb>
        <drugdosagetext>800 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2A</medicinalproduct>
        <drugdosagetext>180 UG/WEEK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142125-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2010IT13379</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>075939</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142126-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2010NL13322</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BABINSKI REFLEX TEST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOTRACHEAL INTUBATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTUBATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
        <drugauthorizationnumb>070673</drugauthorizationnumb>
        <drugdosagetext>75 MG, BID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>SERTRALINE (NGX)</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142127-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2010TN13311</companynumb>
    <primarysource>
      <reportercountry>TUNISIA</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>ERYTHEMA NODOSUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>076192</drugauthorizationnumb>
        <drugdosagetext>800 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2A</medicinalproduct>
        <drugdosagetext>180 UG/WEEK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142128-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2010ES13385</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACILO FERRER FARMA (NGX)</medicinalproduct>
        <drugauthorizationnumb>040772</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100830</drugenddate>
        <drugtreatmentduration>63</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100830</drugenddate>
        <drugtreatmentduration>63</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANULOCYTE COLONY STIMULATING FACTOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NEUTROPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100720</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142129-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2010US13405</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>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUPILLARY LIGHT REFLEX TESTS ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugauthorizationnumb>075985</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND HYDROCODONE BITARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142130-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2010GB13443</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugauthorizationnumb>078528</drugauthorizationnumb>
        <drugdosagetext>3 MG, BID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugauthorizationnumb>078528</drugauthorizationnumb>
        <drugdosagetext>2 MG, BID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMUVAC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INFLUENZA IMMUNISATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142131-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-AVENTIS-2010SA055727</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEVICE MALFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLOSTAR</medicinalproduct>
        <drugbatchnumb>C043</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142132-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ALEXION-A201001290</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>COPPER DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS EROSIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIRIS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAROXYSMAL NOCTURNAL HAEMOGLOBINURIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIRIS</medicinalproduct>
        <drugdosagetext>900 MG, Q12D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIRIS</medicinalproduct>
        <drugdosagetext>900 MG, QW</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080910</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIRIS</medicinalproduct>
        <drugdosagetext>1200 MG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080924</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B12                        /00056201/</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL DISCOMFORT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142133-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2010152829</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHINADVIL</medicinalproduct>
        <drugauthorizationnumb>019771</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101030</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142134-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010149694</companynumb>
    <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>ADVIL</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142135-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010152129</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORNEAL ABRASION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACET JOINT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY CORNEAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SJOGREN'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142136-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100517</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SG-CELGENEUS-141-21880-10051429</companynumb>
    <primarysource>
      <reportercountry>SINGAPORE</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>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142137-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2010DE13619</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>090029</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142138-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>110</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLEX PARTIAL SEIZURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugdosagetext>1/2 TAB -5MG- DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugdosagetext>1 TAB -10MG- DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080608</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142139-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.8633</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOSMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZICAM NASAL GEL NONE MENTIONED ZICAM LLC</medicinalproduct>
        <drugbatchnumb>500016.001</drugbatchnumb>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100314</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142140-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA064779</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>110.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREATININE RENAL CLEARANCE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATOMEGALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE:50 UNIT(S)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>TACHYCARDIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>DOSE:12 UNIT(S)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>VITAMIN D DEFICIENCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugindication>VITAMIN C DEFICIENCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142141-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA067019</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>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE:11 UNIT(S)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTICLICK</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142143-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PRODUCT CONTAMINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHILDREN'S TYLENOL SUSPENSION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHILDREN'S TYLENOL SUSPENSION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHILDREN'S BENADRYL ALLERGY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHILDREN'S TYLENOL PLUS MULTI-SYMPTOM COLD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHILDREN'S TYLENOL PLUS COLD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHILDREN'S MOTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142146-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2010162756</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>DIABETIC COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugdosagetext>160 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142147-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010131777</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>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugdosagetext>15, 1 TAB QAM</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugdosagetext>1 TAB</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugdosagetext>1000 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>250 UG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE PLUS</medicinalproduct>
        <drugdosagetext>1TAB</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>1000 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
        <drugdosagetext>20 MG-25 MG 1 TAB(S) QAM</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>81 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100914</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142148-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010157487</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUBCUTANEOUS ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAC</medicinalproduct>
        <drugauthorizationnumb>050711</drugauthorizationnumb>
        <drugdosagetext>2 DF, 1X/DAY</drugdosagetext>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101125</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>3 DF, A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICON</medicinalproduct>
        <drugdosagetext>3 DF, A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOLVON</medicinalproduct>
        <drugdosagetext>3 DF, A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DASEN</medicinalproduct>
        <drugdosagetext>3 DF, A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101124</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142149-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160902</companynumb>
    <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>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142150-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PFIZER INC-2010124363</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>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA FACIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>20 MG, 1X/DAY AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100922</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>500 MG, 2X/DAY</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELTROXIN</medicinalproduct>
        <drugdosagetext>.75 MG, 1X/DAY</drugdosagetext>
        <drugindication>THYROID DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALL'S COUGH FORMULA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OROPHARYNGEAL PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142151-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010160999</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>DERMATITIS PSORIASIFORM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>019787</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142152-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-15415441</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142153-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-AVENTIS-2010SA071054</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEVICE MALFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLOSTAR</medicinalproduct>
        <drugbatchnumb>0F004A</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>0F004A</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142154-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-CEPHALON-2010006305</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>TREANDA</medicinalproduct>
        <drugauthorizationnumb>022249</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142155-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-10P-167-0663806-00</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>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTED SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100415</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULPHASALAZINE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100415</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBRUPROFEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142156-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-AVENTIS-2010SA071191</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEVICE MALFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLOSTAR</medicinalproduct>
        <drugbatchnumb>0F006A</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>0F006A</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142161-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-SANOFI-AVENTIS-2010SA072387</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEVICE MALFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLOSTAR</medicinalproduct>
        <drugbatchnumb>0F266A</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>0F266A</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142162-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-443569</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEILITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ANXIETY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAND FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MAJOR DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000611</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070719</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142163-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-744044</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugdosagetext>12.5 MG HALF IN THE MORNING AND HALF IN THE AFTERNOON.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND HCT</medicinalproduct>
        <drugdosagetext>16/12.5 MG ONE IN THE MORNING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142164-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-ROCHE-732510</companynumb>
    <primarysource>
      <reportercountry>IRELAND</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>MIRCERA</medicinalproduct>
        <drugdosagetext>FREQUENCY: MONTHLY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142165-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-733124</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>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS ASSOCIATED LYMPHOPROLIFERATIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HASHIMOTO'S ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR LYSIS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142166-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-GENENTECH-310473</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100611</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142167-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-746048</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>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO HEART</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL ARTERY ANEURYSM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPOTECAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142168-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-746112</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>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080731</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>LAST DOSE PRIOR TO SAE 15 SEP 2008, CYCLE 3</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080911</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPOTECAN</medicinalproduct>
        <drugdosagetext>FREQUENCY: 5 CONSECUTIVE DAYS ON DAYS 1-5,</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080731</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMETEROL XINAFOATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIOTROPIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOETIN ALPHA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOLASETRON MESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142169-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-GENENTECH-310515</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>1</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>RANIBIZUMAB</medicinalproduct>
        <drugbatchnumb>122641</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>DIABETIC RETINAL OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
        <drugtreatmentduration>693</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142172-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.8748</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN XL</medicinalproduct>
        <drugbatchnumb>82432AA</drugbatchnumb>
        <drugdosagetext>2 TABS ONCE/DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LYME DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101129</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142174-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.0396</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugbatchnumb>VARIOUS</drugbatchnumb>
        <drugdosagetext>1 TABLET ONCE WEEKLY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142175-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010164128</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>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>020990</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142176-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161293</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugauthorizationnumb>050670</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142177-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010159500</companynumb>
    <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>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LATANOPROST</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142178-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010162362</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142180-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010163200</companynumb>
    <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>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142181-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010157366</companynumb>
    <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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PILOCARPINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZOPT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142182-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJCH-2010027650</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EXPIRED DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISTERINE AGENT COOL BLUE GLACIER MINT</medicinalproduct>
        <drugbatchnumb>2938LZ</drugbatchnumb>
        <drugdosagetext>TEXT:CAPFUL ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DENTAL DISORDER PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101129</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142183-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugdosagetext>10 MG DAILY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142185-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>54.4316</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142187-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>
      <patientweight>103.4201</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE NAPSYLATE W/ ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>N-100 DAILY INJ</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142189-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>68.9467</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRANSDERM SCOP</medicinalproduct>
        <drugbatchnumb>10572</drugbatchnumb>
        <drugdosagetext>1 PATCH BEHIND THE EAR CHANE EVERY 3 DAYS</drugdosagetext>
        <drugindication>MOTION SICKNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142190-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13740BP</companynumb>
    <primarysource>
      <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</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142191-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
        <drugdosagetext>1400 MG Q8H IV BOLUS</drugdosagetext>
        <drugindication>ABSCESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
        <drugdosagetext>1400 MG Q8H IV BOLUS</drugdosagetext>
        <drugindication>DECUBITUS ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101028</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142193-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>109.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugbatchnumb>314317</drugbatchnumb>
        <drugdosagetext>300 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LATENT TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMATROPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142195-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>4MCG/K WEEKLY SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101130</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142196-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010007091</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LUNG CARCINOMA CELL TYPE UNSPECIFIED STAGE IV</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>250 A?G, UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100817</drugenddate>
        <drugtreatmentduration>259</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100122</drugenddate>
        <drugtreatmentduration>52</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugdosagetext>250 UNK, UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100118</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142197-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010164130</companynumb>
    <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 SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIBRAMYCIN</medicinalproduct>
        <drugauthorizationnumb>050007</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CHLAMYDIAL INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142198-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010162505</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>58.957</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PENIS DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101202</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142199-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010163089</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</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>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142200-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101204</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010164181</companynumb>
    <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>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142201-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010156787</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>EXPIRED DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
        <drugdosagetext>UNK GTT, 1X/DAY</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142202-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010157294</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.236</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
        <drugdosagetext>UNK, DAILY</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COSOPT</medicinalproduct>
        <drugdosagetext>UNK, 2X/DAY</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142203-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010155940</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>74.83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MICTURITION URGENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
        <drugdosagetext>1 DROP IN EACH EYE DAILY</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101115</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142204-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101204</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010164144</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>185.94</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTION INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>500 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARIJUANA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COCAINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142205-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010164042</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>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142206-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010163227</companynumb>
    <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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101202</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142207-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GILEAD-2010-0031976</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS FULMINANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugauthorizationnumb>021356</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RALTEGRAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugindication>TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHONDROITIN SULFATE</medicinalproduct>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFAMPICIN</medicinalproduct>
        <drugindication>TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100920</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142209-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-JNJFOC-20101106780</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142210-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-GENZYME-CERZ-1001679</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEREZYME</medicinalproduct>
        <drugauthorizationnumb>020367</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GAUCHER'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142211-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-PFIZER INC-2010063551</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>CARDIOACTIVE DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QRS COMPLEX PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugauthorizationnumb>019787</drugauthorizationnumb>
        <drugdosagetext>300 MG, SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugdosagetext>1200 MG, SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugdosagetext>6000 MG, SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>SOTALOL</medicinalproduct>
        <drugdosagetext>7200 MG, SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>800 MG, SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>7.125 MG, SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ACENOCOUMAROL</medicinalproduct>
        <drugdosagetext>98 MG, SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>PERINDOPRIL</medicinalproduct>
        <drugdosagetext>200 MG, SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142212-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010161008</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROXYZINE HCL</medicinalproduct>
        <drugauthorizationnumb>011459</drugauthorizationnumb>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugindication>NAUSEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142213-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010121186</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>PANNICULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FARMORUBICIN</medicinalproduct>
        <drugauthorizationnumb>050778</drugauthorizationnumb>
        <drugadministrationroute>013</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPIODOL</medicinalproduct>
        <drugadministrationroute>013</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142214-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-GENZYME-CLOF-1001274</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>105</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVOLTRA</medicinalproduct>
        <drugbatchnumb>A453096</drugbatchnumb>
        <drugauthorizationnumb>021673</drugauthorizationnumb>
        <drugdosagetext>35 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101012</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>470 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101014</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IDARUBICIN</medicinalproduct>
        <drugdosagetext>28 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101008</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOBRAMYCIN</medicinalproduct>
        <drugdosagetext>360 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101013</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101013</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SEDATIVE THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101013</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101011</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugdosagetext>400 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101028</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FITOMENADION</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101013</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RASBURICASE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101009</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAUNORUBICIN HCL</medicinalproduct>
        <drugdosagetext>110 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101008</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANEXAMIC ACID</medicinalproduct>
        <drugdosagetext>4000 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101013</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101013</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101015</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101013</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101021</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>2000 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101014</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>80 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101019</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIENAM</medicinalproduct>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101114</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTRAPID</medicinalproduct>
        <drugdosagetext>UNK VISCOSITY UNITS, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101029</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142215-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US82752</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>7142216-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US78640</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>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO CENTRAL NERVOUS SYSTEM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142217-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010CA17466</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STI571/CGP57148B T35717+CAPS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031024</drugenddate>
        <drugtreatmentduration>715</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIVEC</medicinalproduct>
        <drugdosagetext>300MG EVERY OTHER DAY</drugdosagetext>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NILOTINIB</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142218-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US11442</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84.807</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTINIC KERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE REPLACEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTIFICIAL CROWN PROCEDURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BARTHOLIN'S CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE GIANT CELL TUMOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED INTEREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QRS COMPLEX ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM T WAVE INVERSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDODONTIC PROCEDURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCESSIVE GRANULATION TISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID OVERLOAD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIFE EXPECTANCY SHORTENED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE CALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE STRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCCIPITAL NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL FIBROMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYPECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRIMARY SEQUESTRUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVIAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVIAL RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPOROMANDIBULAR JOINT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR EXCISION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS FLOATERS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CODEINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIOTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CROCIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELENIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHROMIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAL-MAG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142219-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010FR17684</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNOSUPPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGOENCEPHALITIS HERPETIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STI571/CGP57148B T35717+CAPS</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142220-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US12136</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICOBRACHIAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNAL FIXATION OF FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAMEDULLARY ROD INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KYPHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGEAL REPAIR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG HYPERINFLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL SEPTAL OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOGENESIS IMPERFECTA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOLOGICAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL CORD COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULNA FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER AIRWAY OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOCAL CORD PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>60 MG EVERY 6 MONTHS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>90 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>60 MG Q3MON</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITONIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFAZOLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN ^A.L.^</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142221-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP75165</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <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>20100921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100926</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TASIGNA</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101026</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPARA-CA</medicinalproduct>
        <drugdosagetext>4 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142222-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP76502</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEM CELL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142224-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20101200498</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>29.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>150 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142225-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100923</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20080300717</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.38</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNSPECIFIED PRODUCT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMEROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INHALERS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142226-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-10P-020-0688729-00</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNIOTIC CAVITY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE SEPARATION OF PLACENTA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UMBILICAL CORD ABNORMALITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE CONTRACTIONS DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DACTIL OB</medicinalproduct>
        <drugindication>THROMBOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142227-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101008</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-CELGENEUS-167-21880-10100846</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TUMOUR FLARE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142231-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-JNJFOC-20101200468</companynumb>
    <primarysource>
      <reportercountry>GREECE</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>ULCERATIVE KERATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>RECEIVED FOR 2 YEARS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142232-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20100704859</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>ABDOMINAL WALL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <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>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIO THREE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN ADRENAL HORMONE PREPARATIONS</medicinalproduct>
        <drugdosagetext>RECEIVED 8 DOSES DURING THIS TIME</drugdosagetext>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN ADRENAL HORMONE PREPARATIONS</medicinalproduct>
        <drugdosagetext>RECEIVED 8 DOSES DURING THIS TIME</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUKERIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELENTAL</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS CITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON DEFICIENCY ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142233-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160973</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PROSTATOMEGALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142234-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010162136</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>100 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142235-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161818</companynumb>
    <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>100 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142236-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010162472</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>29.025</patientweight>
      <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>
        <drugindication>SEXUAL DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142237-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010136244</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugbatchnumb>0773401</drugbatchnumb>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugbatchnumb>0773401</drugbatchnumb>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLOOD GLUCOSE INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142238-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161517</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>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>7142239-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160629</companynumb>
    <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>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142240-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161969</companynumb>
    <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>100 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142241-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-1011USA01135</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>ATYPICAL MYCOBACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD GLUCOSE ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUFAST</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD GLUCOSE ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERNELIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BOWEL MOVEMENT IRREGULARITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMITT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BOWEL MOVEMENT IRREGULARITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142242-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1005USA02316</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>AORTIC ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROFIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL DISEASE CARRIER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PARATHYROID HORMONE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE METABOLISM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE DISPLACEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE NONUNION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR SPINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SICK SINUS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DEFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugauthorizationnumb>021762</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080301</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugauthorizationnumb>021762</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080301</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142243-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-1011USA01308</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>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100505</drugenddate>
        <drugtreatmentduration>575</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100506</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142244-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-1004USA03988</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>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS VIRAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100420</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060415</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050407</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOFERMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROENTERITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100415</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142245-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-MERCK-1009USA01200</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>64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020731</drugenddate>
        <drugtreatmentduration>1849</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
        <drugtreatmentduration>2862</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SODIUM FLUORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19950713</drugenddate>
        <drugtreatmentduration>1508</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE AND ETIDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>14 DAYS EVERY 3 MONTHS</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970630</drugenddate>
        <drugtreatmentduration>700</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142247-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0604USA02026</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>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADRENAL MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARTILAGE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXPOSURE TO COMMUNICABLE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEPTIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY GLAND DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SJOGREN'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENOSYNOVITIS STENOSANS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040330</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTRODIA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UROCIT-K</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ELECTROLYTE SUBSTITUTION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142248-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-1007FRA00087</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142249-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0906USA03786</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>48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREATH ODOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIODONTAL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESBYOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENT DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
        <drugtreatmentduration>329</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060807</drugenddate>
        <drugtreatmentduration>60</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142250-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0705USA02815</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>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADHESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA OF CHRONIC DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRUXISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLUCOSE TOLERANCE IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES SIMPLEX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNOSUPPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOBAR PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARBURG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE ROOT LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS MEDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEPTIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR DENTAL CONDITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST HERPETIC NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST THROMBOTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS PERENNIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRAUMATIC BRAIN INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYMPANIC MEMBRANE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020701</drugenddate>
        <drugtreatmentduration>1869</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070201</drugenddate>
        <drugtreatmentduration>1984</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142251-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0911USA01694</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>47</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALLERGIC SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA MACROCYTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGIODYSPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK FIRST DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AZOTAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ELECTROLYTES ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BULLOUS LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTOCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION VENTRICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESSENTIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICTURITION URGENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROGENIC BLADDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOCTURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCCULT BLOOD POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA KLEBSIELLA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIGHT ATRIAL DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URGE INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR CALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090414</drugenddate>
        <drugtreatmentduration>2575</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOLVADEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER STAGE II</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICRO-K</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNIPHYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090201</drugenddate>
        <drugtreatmentduration>247</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142252-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0911USA04326</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE FRAGMENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMMINUTED FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOCTURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL HERPES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIODONTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVA CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010321</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010321</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142253-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1010USA00071</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>115</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
        <drugbatchnumb>E008844</drugbatchnumb>
        <drugauthorizationnumb>050587</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BACTERAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
        <drugtreatmentduration>47</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BACTERAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101010</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETHAMBUTOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>40</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142254-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0810USA04871</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>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTINIC KERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRUXISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORNEAL ABRASION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCORIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED FASTING GLUCOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTATIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICULAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROSACEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVIAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPOROMANDIBULAR JOINT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHONDROITIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAXSEED</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142255-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1003USA00174</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>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAND FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA OF SKIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142258-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20101104529</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA FUNGAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142259-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-JNJFOC-20101200546</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</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>DEMYELINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC OPTIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142260-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20101200560</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>UVEITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142261-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13664YA</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLOPPY IRIS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMSULOSIN</medicinalproduct>
        <drugdosagetext>0.4 MG</drugdosagetext>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOLOL MALEATE</medicinalproduct>
        <drugindication>INTRAOCULAR PRESSURE TEST</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LATANOPROST</medicinalproduct>
        <drugindication>INTRAOCULAR PRESSURE TEST</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL SODIUM (ALLOPURINOL SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142263-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>105.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142265-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.3075</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORAPREP</medicinalproduct>
        <drugindication>RASH ERYTHEMATOUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORAPREP</medicinalproduct>
        <drugindication>URTICARIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101129</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142267-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.4316</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>10 MG NI PO YEARS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142269-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92.0802</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>1 TABLET DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR II DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050722</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142270-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160347</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>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</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>AMBIEN</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE</medicinalproduct>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142271-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161990</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE THOUGHTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugindication>STRESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugindication>STRESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142272-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010159786</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142273-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161318</companynumb>
    <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>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142274-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010151709</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.562</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugbatchnumb>0583129</drugbatchnumb>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142275-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160678</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>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142276-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-HQWYE216915MAY07</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>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142277-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010159837</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONTANEOUS PENILE ERECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>3 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TESTOSTERONE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL DISCOMFORT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>0.4 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY INCONTINENCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECOSPRIN</medicinalproduct>
        <drugdosagetext>81 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MACULAR DEGENERATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D3</medicinalproduct>
        <drugdosagetext>5000 IU, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142278-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101127</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010159177</companynumb>
    <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 DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142279-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160608</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>105</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ABDOMINAL DISCOMFORT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugdosagetext>2 MG, AS NEEDED</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142280-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010155876</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142281-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2006040903</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53.061</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY HEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PORPHYRINS URINE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT SUBSTITUTION ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugbatchnumb>V091604</drugbatchnumb>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugdosagetext>300 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>300 MG, 4X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugdosagetext>15 MG, 1-2 TABS EVERY HOUR AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPNOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>20 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugdosagetext>20 MG, EVERY 4 HRS AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FATIGUE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugdosagetext>0.4 MG, AS DIRECTED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXANDROLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142282-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160806</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>132</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugdosagetext>80 MG, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
        <drugdosagetext>10 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD POTASSIUM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugdosagetext>2 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN DETEMIR</medicinalproduct>
        <drugdosagetext>25 IU, 1X/DAY</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>81 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>30 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugdosagetext>10/325 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142283-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010159178</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>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>100 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ADVERSE DRUG REACTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRASTUZUMAB</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FASLODEX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142284-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010153373</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142285-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010164110</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>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101125</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142287-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-HQWYE383311NOV04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESTROGEN RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGESTERONE RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>011839</drugauthorizationnumb>
        <drugdosagetext>2.5 MG TAB 5 MGS, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>0.625 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960711</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020409</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALAGEN</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugindication>SJOGREN'S SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACRISERT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DRY EYE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142288-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101127</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010158613</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING DRUNK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOCARBAMOL</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugdosagetext>7.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR SODIUM</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES VIRUS INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142289-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010157300</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>44</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>020216</drugauthorizationnumb>
        <drugdosagetext>UNK, WEEKLY</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142290-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010162082</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
        <drugauthorizationnumb>021845</drugauthorizationnumb>
        <drugdosagetext>40 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142291-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161697</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>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugtreatmentduration>90</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142292-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010159902</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RELPAX</medicinalproduct>
        <drugauthorizationnumb>021016</drugauthorizationnumb>
        <drugdosagetext>40 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101115</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142293-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160012</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugbatchnumb>V092118</drugbatchnumb>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>80 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERIAL STENT INSERTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101120</drugenddate>
        <drugtreatmentduration>37</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVALIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142294-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-US-WYE-H17392410</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENOPAUSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>EVERY OTHER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>NEXT HIGHER DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>NEXT LOWER DOSE ,0.45/1.5</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBANDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>150 MG MONTHLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081230</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE</medicinalproduct>
        <drugdosagetext>0.112 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060322</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METROGEL</medicinalproduct>
        <drugdosagetext>1 PER WEEK</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ROSACEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142295-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010159673</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>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142296-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160651</companynumb>
    <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>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142297-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010159758</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>124.72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HERPES SIMPLEX</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>50 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEXITIL</medicinalproduct>
        <drugdosagetext>200 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>75 UG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>10 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>75 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>ARRHYTHMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLFOLATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TACHYCARDIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE</medicinalproduct>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugdosagetext>400 IU, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>1000 IU, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142298-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161193</companynumb>
    <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>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142299-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161189</companynumb>
    <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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142300-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010162213</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.027</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>40 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101015</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142301-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010163125</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>37.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>020216</drugauthorizationnumb>
        <drugdosagetext>0.625 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>OFF LABEL USE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>020216</drugauthorizationnumb>
        <drugindication>AMENORRHOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>1 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>2 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>5 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROFURANTOIN</medicinalproduct>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DISABILITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugdosagetext>400 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE/COLECALCIFEROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VAGIFEM</medicinalproduct>
        <drugdosagetext>25 UG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA</medicinalproduct>
        <drugdosagetext>846 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIZANIDINE</medicinalproduct>
        <drugdosagetext>2 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOMOTOR HYPERACTIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREGABALIN</medicinalproduct>
        <drugdosagetext>200 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVETIRACETAM</medicinalproduct>
        <drugdosagetext>1000 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142302-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-HQWYE219419JUL04</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>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142303-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010153368</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142304-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160917</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>0.3MG/1.5MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENOPAUSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101127</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugindication>HOT FLUSH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142307-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>11.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVETIRACETAM</medicinalproduct>
        <drugdosagetext>250MG TWICE DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101202</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142309-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>5.4432</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYLAND TEETHING TABLETS</medicinalproduct>
        <drugdosagetext>1 OR 2 TABLETS AS NEEDED PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TEETHING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101016</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142311-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPHRENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>50MG QDAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST-TRAUMATIC STRESS DISORDER</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugdosagetext>50MG QHS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142314-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010132698</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.05</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>2 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142315-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010086359</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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPULSIVE BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MAJOR DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>1 MG CONTINUOUS MONTH PACK</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142316-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010144657</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</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>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142317-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010143781</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST-TRAUMATIC STRESS DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>150 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>OFF LABEL USE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugdosagetext>80 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
        <drugdosagetext>300 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142318-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010158819</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>150 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142319-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2010158988</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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 INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugdosagetext>25 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASTICITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>DIPIPERON</medicinalproduct>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ANTELEPSIN</medicinalproduct>
        <drugdosagetext>1 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090116</drugenddate>
        <drugtreatmentduration>66</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMAL</medicinalproduct>
        <drugdosagetext>100 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugdosagetext>400 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOREM</medicinalproduct>
        <drugdosagetext>20 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL IMPAIRMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>50MG CAPTOPRL/25MG HCT, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEZAFIBRATE</medicinalproduct>
        <drugdosagetext>400 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METABOLIC SYNDROME</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
        <drugdosagetext>200MG DIPYRIDAMOLE/ 25MG ACETYLSALICYLIC ACID  , 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONO</medicinalproduct>
        <drugdosagetext>25 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN</medicinalproduct>
        <drugdosagetext>0.4 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMBUN</medicinalproduct>
        <drugdosagetext>600 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOL</medicinalproduct>
        <drugdosagetext>1 DF, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMIZOLE</medicinalproduct>
        <drugdosagetext>20 GTT, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN DETEMIR</medicinalproduct>
        <drugdosagetext>4 IU, 1X/DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081105</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142320-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010147454</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>117.91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>200 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142321-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2010142758</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>1 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOTANIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142322-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161837</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OBESITY SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142323-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010110107</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>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOMICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</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>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142324-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CL-PFIZER INC-2010155892</companynumb>
    <primarysource>
      <reportercountry>CHILE</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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIMB DISCOMFORT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142325-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2010135908</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>MUCOSAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARGATROBAN</medicinalproduct>
        <drugauthorizationnumb>020883</drugauthorizationnumb>
        <drugdosagetext>2 UG/KG BW/MIN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEPARIN-INDUCED THROMBOCYTOPENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142326-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010110316</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>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOMICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142327-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-PFIZER INC-2010155240</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>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>1 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142328-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010143850</companynumb>
    <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>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142329-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010153826</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>300 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VIITH NERVE PARALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANPLAG</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTERIOSCLEROSIS OBLITERANS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101115</drugenddate>
        <drugtreatmentduration>483</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPALMON</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPINAL COLUMN STENOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101115</drugenddate>
        <drugtreatmentduration>483</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142330-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2010144399</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugauthorizationnumb>008762</drugauthorizationnumb>
        <drugindication>STATUS EPILEPTICUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL</medicinalproduct>
        <drugindication>STATUS EPILEPTICUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142331-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010151172</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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>50 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST HERPETIC NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>100 MG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>150 MG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SHAKUYAKUKANZOUTOU</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONIEL</medicinalproduct>
        <drugdosagetext>4 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142332-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2010163302</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY CHANGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>2 MG, 1X/DAY</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142333-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-PFIZER INC-2010152889</companynumb>
    <primarysource>
      <reportercountry>FINLAND</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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>300 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUETIAPINE FUMARATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
        <drugdosagetext>50 UG/DOSE</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142334-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010110305</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>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5 MG THEN 1MG</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070616</drugenddate>
        <drugtreatmentduration>62</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CHEST PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLOOD PRESSURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUMARIC ACID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142335-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010146464</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.238</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>020151</drugauthorizationnumb>
        <drugdosagetext>75 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>020151</drugauthorizationnumb>
        <drugdosagetext>150 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
        <drugdosagetext>350 MG, 3X/DAY</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142336-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-002012</companynumb>
    <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 INJURY</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>7142337-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-BAXTER-2010BH028707</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</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>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HOLOXAN BAXTER</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TESTIS CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100918</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TESTIS CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UROMITEXAN BAXTER</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TESTIS CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TESTIS CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TESTIS CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100918</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TESTIS CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALIUMKLORID B. BRAUN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TESTIS CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142338-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201007002849</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>SCIATIC NERVE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A709633D</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100422</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142339-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200910008014</companynumb>
    <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>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A595945C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIBRAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142340-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011007707</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VENOUS THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>380 MG, OTHER</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
        <drugtreatmentduration>74</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>570 MG, OTHER</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101025</drugenddate>
        <drugtreatmentduration>67</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>522 MG, OTHER</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101025</drugenddate>
        <drugtreatmentduration>67</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
        <drugdosagetext>2 D/F, EACH EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>40 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>5 MG, EACH EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLOW-MAG</medicinalproduct>
        <drugdosagetext>64 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAL CONTRACEPTIVE NOS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142341-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201002006319</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 THROAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG ADENOCARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A662741D</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A719438D</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>75 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>25 MG, 2/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
        <drugdosagetext>UNK, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOLOL</medicinalproduct>
        <drugdosagetext>UNK, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>5 MG, OTHER</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugdosagetext>100 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DONNATAL</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIACALCIN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITRICAL</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>CENTRUM SILVER</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>200 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
        <drugdosagetext>15 MG, EACH EVENING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 3</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>UNK, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142342-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201009001015</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 FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A728052C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101008</drugenddate>
        <drugtreatmentduration>44</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A719441C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>40 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugdosagetext>120 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>30 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>10 MG, 2/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugdosagetext>1 D/F, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>1 D/F, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugdosagetext>1 D/F, DAILY (1/D)</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142343-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201003005188</companynumb>
    <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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A555707C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100206</drugenddate>
        <drugtreatmentduration>79</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>UNK, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>UNK, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>UNK, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>2000 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>UNK, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITRACAL-D</medicinalproduct>
        <drugdosagetext>600 MG, DAILY (1/D)</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142344-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200909003752</companynumb>
    <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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A719441C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A728052C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A723778C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
        <drugdosagetext>3 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTYNIN</medicinalproduct>
        <drugdosagetext>30 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>3 D/F, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>3000 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
        <drugdosagetext>2 D/F, DAILY (1/D)</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugdosagetext>2 D/F, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>1 D/F, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STOOL SOFTENER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142345-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201006006379</companynumb>
    <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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS MEDIA ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WALKING AID USER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINERALS NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM MAGNESIUM</medicinalproduct>
        <drugdosagetext>UNK, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>UNK, DAILY (1/D)</drugdosagetext>
        <drugindication>OEDEMA PERIPHERAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>25 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>0.3 MG, DAILY (1/D)</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142346-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200912001758</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>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A531650C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>20 MEQ, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugdosagetext>15 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>300 MG, 3/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>5 MG, 2/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBIDOPA + LEVODOPA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugdosagetext>15 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>0.5 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142347-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201007000397</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERMAL BURN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A709633D</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090828</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A713107C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A719441C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142348-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010003405</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>350 A?G, UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100308</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142349-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU409192</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRODUCT TRANSFUSION DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW RETICULIN FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK UNK, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROID NOS</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNOGLOBULINS</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142350-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-QUU411196</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BETA HAEMOLYTIC STREPTOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142351-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-KDC434267</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS ACNEIFORM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANITUMUMAB</medicinalproduct>
        <drugdosagetext>6 MG/KG, Q2WK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100817</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100817</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100802</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100802</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100817</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100817</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM LEVOFOLINATE</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100802</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM LEVOFOLINATE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100817</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTAZOCINE LACTATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYDOXAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIRUDOID SOFT OINTMENT</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMITT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TELEMINSOFT</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POSTERISAN OINTMENT</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142354-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10113027</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 MG - 10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142355-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-10P-028-0687898-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52.664</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101017</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142357-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-CELGENEUS-087-21880-10112713</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>78.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TETANY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101007</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LENADEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101011</drugenddate>
        <drugtreatmentduration>47</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142358-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10113081</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 LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142360-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010152510</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>225 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST HERPETIC NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLANAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOSOMATIC DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELENICA-R</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEROCRAL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142361-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PFIZER INC-2010157911</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142362-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010157272</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>50 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101121</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>SPINAL COLUMN STENOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142364-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13368BP</companynumb>
    <primarysource>
      <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 150</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021698</drugauthorizationnumb>
        <drugdosagetext>1 TAB BID PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142365-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC.-2010-RO-01405RO</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugbatchnumb>059741A,060291A</drugbatchnumb>
        <drugauthorizationnumb>022207</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugbatchnumb>059741A,060291A</drugbatchnumb>
        <drugauthorizationnumb>022207</drugauthorizationnumb>
        <drugdosagetext>45 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
        <drugindication>LYME DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142366-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC.-2010-RO-01565RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugauthorizationnumb>077262</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142367-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010KR82425</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</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>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG/100 ML</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091006</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142369-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-709625</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACUTAN</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>STRENGTH: 20 MG, INDICATION: RESISTANT ACNE.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACUTAN</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>STRENGTH 10 AND 20 MG, INDICATION: ACNE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACUTAN</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>DOSE INCREASED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACUTAN</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>DOSE DECREASED.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METICORTEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METICORTEN</medicinalproduct>
        <drugdosagetext>DOSE DECREASED.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METICORTEN</medicinalproduct>
        <drugdosagetext>DOSE DECREASED.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFONA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142370-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ALLERGAN-1015452US</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEEDING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOXA?</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>TORTICOLLIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080429</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOXA?</medicinalproduct>
        <drugindication>MUSCLE SPASTICITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOXA?</medicinalproduct>
        <drugindication>PAIN IN EXTREMITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOXA?</medicinalproduct>
        <drugindication>MUSCLE TIGHTNESS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142371-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060929</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-746179</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142372-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-10P-087-0689572-00</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>CHOLANGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPLIN SR FOR INJECTION 11.25 MG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020708</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER STAGE III</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BICALUTAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER STAGE III</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142373-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090903</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-CELGENEUS-056-21880-10081720</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142375-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011002460</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>KNEE OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142376-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201010002640</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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101129</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142377-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201009002795</companynumb>
    <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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A719441C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A723778C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142378-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201009005658</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>APHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IDIOPATHIC PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYMYALGIA RHEUMATICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPORAL ARTERITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A719441C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>14 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>10 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>5 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugdosagetext>50 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE/VITAMIN D3</medicinalproduct>
        <drugdosagetext>UNK, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142379-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201010007096</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>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>2000 IU, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHAZYME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM /00033702/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142380-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201010002321</companynumb>
    <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>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A723778C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100712</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142381-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201009005875</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>40.816</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100907</drugenddate>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142382-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201010001866</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>43.991</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL ADHESIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPARATHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>5 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>2 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>0.062 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugdosagetext>600 MG, 2/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGACE ES</medicinalproduct>
        <drugdosagetext>800 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142383-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201009007167</companynumb>
    <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>JOINT DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEELCHAIR USER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A728051C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>110 UG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>30 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM W/VITAMIN D NOS</medicinalproduct>
        <drugdosagetext>1200 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZIDE</medicinalproduct>
        <drugdosagetext>UNK, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugdosagetext>UNK, 2/D</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELATONIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>UNK, EACH EVENING</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTASIS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142384-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090903</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-CELGENEUS-056-21880-10082096</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080807</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142387-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10071488</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>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100710</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142388-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160521</companynumb>
    <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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>020151</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142389-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161198</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>AKATHISIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142390-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010140177</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142392-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161172</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>TARDIVE DYSKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142393-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010123370</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>104.31</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugbatchnumb>PD158</drugbatchnumb>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142394-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160511</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142395-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010156074</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROXYZINE HCL</medicinalproduct>
        <drugauthorizationnumb>011459</drugauthorizationnumb>
        <drugdosagetext>10 MG, 3X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROXYZINE HCL</medicinalproduct>
        <drugauthorizationnumb>011459</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GUAIFENESIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142396-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161675</companynumb>
    <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>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142397-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010159753</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>020151</drugauthorizationnumb>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugauthorizationnumb>020151</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142398-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010155024</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142399-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161174</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>AKATHISIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142400-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161212</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>AKATHISIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142401-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010164052</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>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142402-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010164137</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugauthorizationnumb>020280</drugauthorizationnumb>
        <drugdosagetext>2 MG, DAILY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HYPOPITUITARISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142403-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010162545</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>
      <patientweight>68.946</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYCLINE</medicinalproduct>
        <drugindication>ACNE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142404-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010159879</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>CONCOMITANT DISEASE AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>37.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GENERALISED ANXIETY DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE</medicinalproduct>
        <drugdosagetext>37.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GENERALISED ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142405-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10113091</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>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142406-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10113255</companynumb>
    <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>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142410-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RO-CELGENEUS-135-21880-10102610</companynumb>
    <primarysource>
      <reportercountry>ROMANIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101123</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142411-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10120139</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090801</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN N + R</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142414-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10080882</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>47.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD HUMAN CHORIONIC GONADOTROPIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100924</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142415-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010164107</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTROL</medicinalproduct>
        <drugauthorizationnumb>020714</drugauthorizationnumb>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142416-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010121715</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>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOMICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARITAL PROBLEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>98</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>EMPHYSEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142417-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010138807</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.378</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>200 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL/ CAFFEINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142418-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010153383</companynumb>
    <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>WRONG DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142419-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101205</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010164203</companynumb>
    <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>PAIN</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>20101204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101205</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142420-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2010160468</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142421-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010163654</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>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142422-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010155922</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>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142423-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010120472</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>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142424-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010163298</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>CHEILITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugauthorizationnumb>020322</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FUNGAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100929</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142425-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010159922</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugbatchnumb>V101385</drugbatchnumb>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugdosagetext>100 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142426-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010153083</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142427-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010162667</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142428-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010154666</companynumb>
    <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>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142429-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010105724</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>STARTER PACK-0.5 MG, 1MG</drugdosagetext>
        <drugindication>NICOTINE DEPENDENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071228</drugenddate>
        <drugtreatmentduration>64</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142430-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010150627</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>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142431-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161770</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142432-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161527</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>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142433-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160548</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>ELECTROCARDIOGRAM ST SEGMENT ELEVATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142434-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010121716</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>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, UNK</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142435-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010151003</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>83.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GLOSSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALAVERT</medicinalproduct>
        <drugbatchnumb>C60002</drugbatchnumb>
        <drugauthorizationnumb>021375</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142436-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010130826</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.912</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>200 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142437-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160010</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>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugindication>LIVER DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142438-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010164140</companynumb>
    <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>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142439-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2010160133</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>ERYTHEMA NODOSUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TONSILLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100818</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OROKEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TONSILLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100818</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOLIPRANE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>TONSILLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100816</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142440-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161579</companynumb>
    <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 THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
        <drugauthorizationnumb>021228</drugauthorizationnumb>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142441-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-PFIZER INC-2010159542</companynumb>
    <primarysource>
      <reportercountry>INDIA</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>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugauthorizationnumb>008762</drugauthorizationnumb>
        <drugdosagetext>300 MG, DAILY</drugdosagetext>
        <drugindication>GRAND MAL CONVULSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142442-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010154627</companynumb>
    <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>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142443-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161955</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>AMENORRHOEA</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>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142444-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010159822</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>143.31</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <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>20091201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROPINIROLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugdosagetext>100 MG, 2X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142445-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010124258</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>COMPLETED SUICIDE</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>20070201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>STARTER PACK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142446-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010117487</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142447-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010148610</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>ABDOMINAL PAIN LOWER</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>20101109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101111</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>50 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL</medicinalproduct>
        <drugdosagetext>5 MG, 1X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142448-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010159936</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53.968</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUNBURN</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>20101125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101128</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101129</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142449-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010163651</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>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142450-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161835</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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142451-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010110318</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>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</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>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142452-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010159483</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>111</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MOOD SWINGS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142453-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161677</companynumb>
    <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>PRODUCT PACKAGING ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TABLET ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALAVERT</medicinalproduct>
        <drugauthorizationnumb>021375</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142454-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010150784</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVERSION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugdosagetext>0.25 MG, AS NEEDED</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142455-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010163378</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCARDIA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEVACOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICROZIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142456-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010150639</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142457-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010150978</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALAVERT</medicinalproduct>
        <drugauthorizationnumb>021375</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142458-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010163440</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142459-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161186</companynumb>
    <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>DETROL</medicinalproduct>
        <drugauthorizationnumb>020771</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DITROPAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142460-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010162541</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>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142461-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010162414</companynumb>
    <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>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101118</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142462-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010163632</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</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>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142463-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010101438</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>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSTILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>STARTER PACK (1MG AND 0.5 MG)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142464-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010149189</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142465-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010150342</companynumb>
    <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>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142466-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161805</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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142467-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010163105</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</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>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, 2X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>1 MG, 2X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142468-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010164143</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CAPILLARY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>200 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
        <drugdosagetext>0.5 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIAZAC</medicinalproduct>
        <drugdosagetext>300 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>80 MG, DAILY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>20 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142469-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010148215</companynumb>
    <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>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142470-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010149897</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>40 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>50 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>0.81 MG, DAILY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142471-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161814</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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070824</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142472-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010163630</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>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE INJURIES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142473-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161808</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>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070119</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142474-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SK-CELGENEUS-260-21880-10111069</companynumb>
    <primarysource>
      <reportercountry>SLOVAKIA (Slovak Republic)</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>LEUKAEMIA PLASMACYTIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142475-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-TEVA-258172ISR</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugauthorizationnumb>076052</drugauthorizationnumb>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142476-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201012001181</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRASUGREL HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIPLATELET THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugdosagetext>25 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>40 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142477-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ELI_LILLY_AND_COMPANY-GB201007001937</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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>500 MG/M2, UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>75 MG/M2, UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAMORPH SR</medicinalproduct>
        <drugdosagetext>5-10MG, 4-6 TIMES DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100528</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>1 G, 4/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
        <drugdosagetext>10 MG, EACH EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA</medicinalproduct>
        <drugdosagetext>2 D/F, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100625</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugdosagetext>4 MG, 3/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIEMETIC SUPPORTIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
        <drugdosagetext>10 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIEMETIC SUPPORTIVE CARE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugdosagetext>10 MG,  ONCE DAILY EACH EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>400 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>1000 UG, EVERY 9 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100329</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142478-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201010004007</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TASISULAM SODIUM</medicinalproduct>
        <drugdosagetext>1538 MG, ON DAY 4, CYCLE 1 ONLY, OF 28-DAY CYCLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>375 MG/M2, ON DAY 1, CYCLE 1, OF 28-DAY CYCLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090127</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090127</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
        <drugindication>CONSTIPATION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugindication>CONSTIPATION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>BLOOD OESTROGEN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091127</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>I.V. SOLUTIONS</medicinalproduct>
        <drugindication>OROPHARYNGEAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101014</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142479-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011001817</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>500 MG/M2, EVERY 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>6 AUC, EVERY 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIHEXYPHENIDYL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEXOFENADINE HCL</medicinalproduct>
        <drugdosagetext>180 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOLTERODINE TARTRATE</medicinalproduct>
        <drugdosagetext>2 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>500 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPROMAZINE</medicinalproduct>
        <drugdosagetext>2 TABS EVERY AM, 3 TABS EVERY HS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN GLARGINE</medicinalproduct>
        <drugdosagetext>20 U, EACH EVENING</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
        <drugdosagetext>10 MG, Q6H AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESZOPICLONE</medicinalproduct>
        <drugdosagetext>2 MG, EACH EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142480-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201009001750</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82.086</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>500 MG/M2, EVERY 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>6 AUC, EVERY 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT B12</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIHEXYPHENIDYL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEXOFENADINE HCL</medicinalproduct>
        <drugdosagetext>180 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOLTERODINE TARTRATE</medicinalproduct>
        <drugdosagetext>2 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>500 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPROMAZINE</medicinalproduct>
        <drugdosagetext>100 MG, 2 TABS EACH AM, 3 TABS EVERY HS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN GLARGINE</medicinalproduct>
        <drugdosagetext>20 U, EACH EVENING</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
        <drugdosagetext>10 MG, Q6H AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESZOPICLONE</medicinalproduct>
        <drugdosagetext>2 MG, EACH EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142481-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ELI_LILLY_AND_COMPANY-GB201007002472</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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>500 MG/M2, ON DAY 1 EVERY 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>75 MG/M2, ON DAY 1 EVERY 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugdosagetext>UNK, ON DAY 1 EVERY 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100609</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142482-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13546BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMPULSIVE SHOPPING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELINGS OF WORTHLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOLOGICAL GAMBLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142483-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13738BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>004318A</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100924</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142484-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13784BP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142485-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13331BP</companynumb>
    <primarysource>
      <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>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142486-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-ROXANE LABORATORIES, INC.-2010-RO-01566RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC URAEMIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugauthorizationnumb>074069</drugauthorizationnumb>
        <drugdosagetext>75 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugauthorizationnumb>065178</drugauthorizationnumb>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugdosagetext>6 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142492-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010148394</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOODY DISCHARGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROBITUSSIN COUGH AND COLD CF</medicinalproduct>
        <drugdosagetext>UNK ML, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142493-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA-2010-0056687</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>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022272</drugauthorizationnumb>
        <drugdosagetext>160 MG, Q12H</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142494-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA073023</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>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONCUSSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>C360</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE:15 UNIT(S)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLOSTAR</medicinalproduct>
        <drugbatchnumb>C360</drugbatchnumb>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugbatchnumb>DBR1857</drugbatchnumb>
        <drugauthorizationnumb>020496</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142495-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-JNJFOC-20101200409</companynumb>
    <primarysource>
      <reportercountry>INDIA</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>NEUTROPENIC SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BONE SARCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BONE SARCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BONE SARCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BONE SARCOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142499-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20100805213</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>EPICONDYLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142500-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20100502967</companynumb>
    <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>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHILDREN'S MOTRIN</medicinalproduct>
        <drugauthorizationnumb>019842</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142501-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20101200527</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>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <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>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142502-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101106329</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PERIRECTAL ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTIC</medicinalproduct>
        <drugindication>INFLAMMATORY BOWEL DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142503-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20090906498</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>48</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <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>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142504-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101200589</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <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>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142505-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA-2010-0056270</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>BRUGADA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021745</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142506-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10100331</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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142507-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101200578</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>43</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142508-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101109114</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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugauthorizationnumb>017821</drugauthorizationnumb>
        <drugdosagetext>60 TO 80 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAVELLA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAVELLA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAVELLA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAVELLA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAZODONE</medicinalproduct>
        <drugdosagetext>600 TO 800 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAZODONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
        <drugdosagetext>3 GLASSES OF WINE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142509-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101201682</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>
      <patientweight>11.34</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL DRUG INTAKE BY CHILD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID COMPLETE</medicinalproduct>
        <drugbatchnumb>BEF033</drugbatchnumb>
        <drugauthorizationnumb>020958</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID COMPLETE</medicinalproduct>
        <drugbatchnumb>BEF033</drugbatchnumb>
        <drugauthorizationnumb>020958</drugauthorizationnumb>
        <drugdosagetext>1/2 BOTTLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACCIDENTAL EXPOSURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142513-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20101202421</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>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC TAMPONADE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142514-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20101202194</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>BRAIN INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugadministrationroute>022</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugadministrationroute>022</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142515-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101202226</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142516-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20100600145</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>
      <patientweight>55.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL T-CELL LYMPHOMA UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAMORPH SR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142517-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2010162202</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHINADVIL</medicinalproduct>
        <drugauthorizationnumb>019771</drugauthorizationnumb>
        <drugdosagetext>1 DF, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHINITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142518-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH027584</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>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID OVERLOAD</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142519-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-ABBOTT-10P-009-0686910-00</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMORAL NECK FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRENANTONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020708</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142520-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-10P-167-0688551-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018723</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>AFFECTIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>425 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050605</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142521-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101015</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010ZA82546</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>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG/100 ML</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142522-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028351</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>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101025</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142526-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CO82583</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</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>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5MG/100 ML</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091112</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142527-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010ES17901</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLANGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALISKIREN ALI+TAB+CVR</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>CODE NOT BROKEN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOVASCULAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100906</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALISKIREN ALI+TAB+CVR</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>NO TREATMENT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100929</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALISKIREN ALI+TAB+CVR</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>CODE NOT BROKEN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100930</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142528-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010SI81825</companynumb>
    <primarysource>
      <reportercountry>SLOVENIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC SPECIFIC ANTIGEN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONATE T29581+</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG EVERY 28 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETONAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061114</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142529-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US68993</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY OF PARTNER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TASIGNA</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101007</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TASIGNA</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101010</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142530-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA82565</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142531-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US01254</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.19</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AURICULAR PERICHONDRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD THYROID STIMULATING HORMONE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIAL HYPERREACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CACHEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROSTOMY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOITRE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BLADDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL MUCOSAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OOPHORECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS CONSTRICTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRIMARY SEQUESTRUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVIAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE LEIOMYOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>UNK,UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>UNK,UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050624</drugenddate>
        <drugtreatmentduration>934</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugdosagetext>1 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80/12.5</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>MS CONTIN</medicinalproduct>
        <drugdosagetext>15 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>5-FU</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FASLODEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE SULFATE W/CHONDROITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142532-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100601</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201006001015</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>EPITHELIOID SARCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142533-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028902</companynumb>
    <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 INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101122</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142534-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10120266</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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142535-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ALLERGAN-1015226US</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>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID PTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOX COSMETIC</medicinalproduct>
        <drugbatchnumb>C2624</drugbatchnumb>
        <drugdosagetext>54 UNITS, SINGLE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SKIN WRINKLING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100909</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUVEDERM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SKIN WRINKLING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100909</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142536-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10091882</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>RENAL AMYLOIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOTIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugdosagetext>7.5/500MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142537-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101108806</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHILDREN'S TYLENOL SUSPENSION</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHILDREN'S TYLENOL SUSPENSION</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHILDREN'S MOTRIN</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>020516</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHILDREN'S MOTRIN</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>020516</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142538-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10110156</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 LYMPHOCYTIC LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142542-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010JP18077</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>RECTAL CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMATINIB</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
        <drugtreatmentduration>462</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BOSUTINIB</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
        <drugtreatmentduration>471</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMEBUTINE MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLOPATADINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLAPREZINC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142543-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010GB18385</companynumb>
    <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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMATINIB</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142544-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010MX45264</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG/100 ML</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090315</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142545-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010MX46633</companynumb>
    <primarysource>
      <reportercountry>MEXICO</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>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG/100 ML, A YEAR</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142546-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2010162573</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL EXTRA ALIVIO</medicinalproduct>
        <drugauthorizationnumb>020402</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFLUENZA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENOCUR TRIPLEX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PERIPHERAL VASCULAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142547-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10101873</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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100930</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142548-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10040445</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 MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELOFIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELOFIBROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142549-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10100587</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>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091007</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142550-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10042200</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>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME TRANSFORMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100210</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEFLEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142551-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-183748USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66.738</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST-TRAUMATIC STRESS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
        <drugindication>MUSCLE SPASMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050818</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugindication>HOT FLUSH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142555-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10120143</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AMYLOIDOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142556-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10100207</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 MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME TRANSFORMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100816</drugenddate>
        <drugtreatmentduration>76</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DANAZOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100809</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142557-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-249381USA</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>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>074949</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142558-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-251596USA</companynumb>
    <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>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORDIAZEPOXIDE HCL</medicinalproduct>
        <drugbatchnumb>315847</drugbatchnumb>
        <drugauthorizationnumb>083116</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142559-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-251739USA</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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100815</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142560-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-254558USA</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>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>074949</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142561-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-256192USA</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>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>076135</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101005</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142562-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-256951USA</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>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugauthorizationnumb>072234</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142563-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-CELGENEUS-114-50794-10102756</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC ANEURYSM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDAZA</medicinalproduct>
        <drugauthorizationnumb>050794</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100830</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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    </patient>
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  <safetyreport>
    <safetyreportid>7142564-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10113199</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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142565-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13781BP</companynumb>
    <primarysource>
      <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>003153B,0D1006</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>003153B,0D1006</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugindication>EMPHYSEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
        <drugindication>ALOPECIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTEO BIFLEX</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142566-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13675BP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142567-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13783BP</companynumb>
    <primarysource>
      <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>SPIRIVA</medicinalproduct>
        <drugbatchnumb>003421A,0D1007</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>ADVAIR</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142568-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13759BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>003995A,0C2200</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142569-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-253082USA</companynumb>
    <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 BONES FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIUS FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugauthorizationnumb>020622</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142570-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-EISAI INC.-E2020-07780-SPO-JP</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugauthorizationnumb>020690</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugauthorizationnumb>020690</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRAMALIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142571-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ABBOTT-10P-008-0685397-00</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REDUCTIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020632</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142574-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2010164191</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>AZOOSPERMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLOR</medicinalproduct>
        <drugauthorizationnumb>019787</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIZIDE</medicinalproduct>
        <drugdosagetext>20/12.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142575-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010162793</companynumb>
    <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 HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>2 DF, 1X/DAY</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142576-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010162645</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>REVATIO</medicinalproduct>
        <drugauthorizationnumb>021845</drugauthorizationnumb>
        <drugdosagetext>20 MG, 2X/DAY</drugdosagetext>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142577-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010162582</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142578-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010162026</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.238</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLAR HYPERTROPHY</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>20090301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAPSONE</medicinalproduct>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GRANULOMA ANNULARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101129</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142579-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010163115</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>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, 1X/DAY</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
      </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>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugdosagetext>UNK, 3X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONTELUKAST</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142580-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010163885</companynumb>
    <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>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142581-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010164309</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>TRAUMATIC BRAIN INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOMATROPIN</medicinalproduct>
        <drugauthorizationnumb>020280</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPOPITUITARISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142582-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010159808</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugindication>SEASONAL ALLERGY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142583-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010164264</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>TYPE 1 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOMATROPIN</medicinalproduct>
        <drugauthorizationnumb>020280</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142584-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2009221009</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAROSMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, 1X/DAY</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090516</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>1 MG, 2X/DAY</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE AND ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142585-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-SANOFI-AVENTIS-2010SA073214</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>100</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</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>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SHORANT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021629</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAMYR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMINO ACIDS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101122</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142590-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJCH-2010026620</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>83.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EXPIRED DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EROSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISTERINE WHITENING QUICK DISSOLVING STRIPS</medicinalproduct>
        <drugbatchnumb>3160857</drugbatchnumb>
        <drugdosagetext>TEXT:TWO STRIPS ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DENTAL CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>TEXT:1X A DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>THROMBOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142591-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7030386</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUROMYELITIS OPTICA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142592-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MY-CELGENEUS-101-20785-10120155</companynumb>
    <primarysource>
      <reportercountry>MALAYSIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugauthorizationnumb>020785</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAMIDRONATE DISODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142593-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0683461-00</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>ARTERIOSCLEROSIS CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100501</drugenddate>
      </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>ATENOLOL</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>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</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>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142594-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101205</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010164296</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>100.23</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
        <drugauthorizationnumb>021228</drugauthorizationnumb>
        <drugdosagetext>4 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLADDER DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>500 MG, DAILY</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142595-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010128941</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>REVATIO</medicinalproduct>
        <drugauthorizationnumb>021845</drugauthorizationnumb>
        <drugdosagetext>20 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142596-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010158695</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GLOMERULONEPHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZULFIDINE</medicinalproduct>
        <drugauthorizationnumb>007073</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142597-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20101109123</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>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMPONI</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMPONI</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMPONI</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMPONI</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMPONI</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMPONI</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MTX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALIMUMAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM SANDOZ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERRO SANOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142598-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-10P-062-0687768-00</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>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARCOXIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARCOXIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142599-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ABBOTT-10P-013-0688722-00</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHOEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>ABDOMINAL PAIN UPPER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTREVA</medicinalproduct>
        <drugindication>MENOPAUSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030131</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>D-CURE</medicinalproduct>
        <drugindication>VITAMIN D DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUTHYROX</medicinalproduct>
        <drugdosagetext>50 MCG DAILY</drugdosagetext>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOFENAC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETICS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONTRAMAL RETARD</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CACIT 500</medicinalproduct>
        <drugindication>CALCIUM DEFICIENCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERSYL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142600-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-ABBOTT-10P-009-0682132-00</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INGUINAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL RESECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEMPLAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020819</drugauthorizationnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100922</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLEOVIT D3</medicinalproduct>
        <drugdosagetext>8000 IE / WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOMONAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOLOC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100928</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142601-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006810</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLIA</medicinalproduct>
        <drugbatchnumb>1021135</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100916</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142603-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CEPHALON-2010006199</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>122</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugauthorizationnumb>020717</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FATIGUE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEEP VEIN THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142604-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA073301</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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE:35 UNIT(S)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142605-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GILEAD-2010-0034149</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DUODENAL STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugauthorizationnumb>021752</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STOCRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPZICOM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OPPORTUNISTIC INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100204</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142606-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10082758</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FULL BLOOD COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AMYLOIDOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100823</drugenddate>
        <drugtreatmentduration>62</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142610-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13782BP</companynumb>
    <primarysource>
      <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>LARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-CARDIAC CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</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>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101129</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142611-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13776BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142612-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-12907BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER PROLAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DULCOLAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DULCOLAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142613-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13679BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOKING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL SPASM</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>20101126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101129</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </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>20101130</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZEBETA</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142614-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC.-2010-RO-01571RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEGIONELLA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORGANISING PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugauthorizationnumb>084610</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CENTRAL NERVOUS SYSTEM LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142615-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10113189</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100921</drugenddate>
        <drugtreatmentduration>209</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142620-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2010163246</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>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROGENIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBULOINTERSTITIAL NEPHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142621-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010162910</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142622-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010163999</companynumb>
    <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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142623-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-257403USA</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 AORTIC ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL AORTIC VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL HEPATIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY VALVE STENOSIS CONGENITAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugauthorizationnumb>076618</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142624-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-745784</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugdosagetext>ROUTE: ENDOVENOUS</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ANAESTHETIC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUTHYROX</medicinalproduct>
        <drugdosagetext>START: MORE THAN 20 YEAR AGO</drugdosagetext>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MODURETIC 5-50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NISULID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142625-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-727122</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>2 WEEKS ADMINISTRATION FOLLOWED BY 1 WEEK REST</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLON CANCER RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLON CANCER RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100603</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELPLAT</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100603</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100617</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142626-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2010US18339</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>104.31</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAALOX ANTACID/ANTIGAS MAX QDTABS ASST (NCH)</medicinalproduct>
        <drugdosagetext>4 DF,  (1 TIME A DAY) QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101130</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAALOX ANTACID/ANTIGAS MAX QDTABS ASST (NCH)</medicinalproduct>
        <drugdosagetext>UNK, PRN (^STARTED 20 YEARS AGO; WHEN SYMPTOMS OCCUR, NOT DAILY^)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142627-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2010US11305</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAALOX ADV MAXIMUM STRENGTH ANTACID/ANTIGAS (NCH)</medicinalproduct>
        <drugbatchnumb>10075419</drugbatchnumb>
        <drugdosagetext>1 TSP, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100705</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142628-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-735147</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>FORM: INFUSION.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>DRUG: MYLAN OMEPRAZOLE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBAZAM</medicinalproduct>
        <drugdosagetext>DRUG: TEVA CLOBAZAM</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REACTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142629-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-738607</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>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL HERPES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>B60050, B60110, B60120</drugbatchnumb>
        <drugdosagetext>FORM: INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100924</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugdosagetext>1 MG SUBLINGUAL INTRAVENOUS ONCE DAILY</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRAVOL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AERIUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100918</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VP 16</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100918</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142630-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA072693</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEVICE MALFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLOSTAR</medicinalproduct>
        <drugbatchnumb>0F172A</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>0F172A</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142634-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-JPNCT2010007479</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANITUMUMAB</medicinalproduct>
        <drugdosagetext>6 MG/KG, Q2WK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM LEVOFOLINATE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142635-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090304</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-CELGENEUS-056-21880-09020407</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BILE DUCT CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081022</drugenddate>
        <drugtreatmentduration>172</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081022</drugenddate>
        <drugtreatmentduration>172</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081022</drugenddate>
        <drugtreatmentduration>172</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142636-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-257413USA</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>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugauthorizationnumb>070819</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142637-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-257911USA</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>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARAVIS</medicinalproduct>
        <drugauthorizationnumb>076135</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142638-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-257920USA</companynumb>
    <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>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>076277</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142639-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-257932USA</companynumb>
    <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>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>070146</drugauthorizationnumb>
        <drugindication>JOINT INJURY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100920</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142640-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-TEVA-258388USA</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAN B</medicinalproduct>
        <drugauthorizationnumb>021045</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST COITAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142645-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7028587</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>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090828</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142646-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-10P-087-0688174-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INFLUENZA VACCINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101112</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142647-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0688208-00</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>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGAMENT RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMCOR</medicinalproduct>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</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>UNKNOWN STEROID CREAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142648-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HU-ABBOTT-10P-076-0627689-00</companynumb>
    <primarysource>
      <reportercountry>HUNGARY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090902</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>15 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090902</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE ACETATE</medicinalproduct>
        <drugdosagetext>8 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugdosagetext>15 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090902</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142649-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ABBOTT-10P-013-0685134-00</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAREVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142650-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-10P-028-0675959-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>4 TABLETS ONCE A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PMS INDAPAMIDE</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>HYDROXYZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <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>ALENDRONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>1/2 TAB TWICE A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <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>ZOPICLONE</medicinalproduct>
        <drugdosagetext>2 TABLETS AT BED TIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>2 TABLETS ONCE A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
        <drugdosagetext>2 TABLETS ONCE A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142651-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-10P-167-0688166-00</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>PENILE ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TESTICULAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TESTICULAR SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142652-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0689381-00</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</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>ADVAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>PATCHES EVERY 72 HOURS</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDODERM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142653-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-CEPHALON-2010006100</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>DRUG PRESCRIBING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIDRADENITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugdosagetext>600-800MGS PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NARCOLEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142654-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2009-BP-08108BP</companynumb>
    <primarysource>
      <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>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED UPPER AIRWAY SECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>002581A,9D1018</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>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>002581A,9D1018</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugindication>EMPHYSEMA</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>ATENOLOL</medicinalproduct>
        <drugdosagetext>50 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYCO MATO</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAW PALMETTO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>25 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYCOPENE</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142655-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDC437276</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>VARICELLA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CINACALCET HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>021688</drugauthorizationnumb>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugindication>HYPERPARATHYROIDISM SECONDARY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100706</drugenddate>
        <drugtreatmentduration>51</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>5 MG, QHS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION</medicinalproduct>
        <drugdosagetext>150 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>25 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>2 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHOSLO</medicinalproduct>
        <drugdosagetext>UNK UNK, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
        <drugdosagetext>10 MG, QID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
        <drugdosagetext>650 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>18 A?G, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142656-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-ABBOTT-10P-009-0686352-00</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NEURITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL EVOKED POTENTIALS ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG INTOLERANCE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142657-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ABBOTT-10P-114-0689174-00</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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 INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBULOINTERSTITIAL NEPHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>BORTEZOMIB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>BORTEZOMIB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>REDUCED DOSE AT 50%</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142658-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CZ-ABBOTT-10P-217-0688216-00</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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE INJURIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONEAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENIC RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRAUMATIC LUNG INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090623</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>PREDNISONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBALGIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIGANTOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULCOSAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142659-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028465</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101027</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142660-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033175</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>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142661-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH007370</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIEPILEPTICS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142662-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH026551</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>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081029</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142663-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010007564</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>NPLATE</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142664-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010007574</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142665-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH001595</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE EMERGENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARATHYROID DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENIC RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR GRAFT THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CENTRAL VENOUS CATHETERISATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HAEMODIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080326</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080326</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080331</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080331</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINOXIDIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</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>METOPROLOL</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>PROMETHAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KENALOG</medicinalproduct>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050819</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
        <drugadministrationroute>061</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>INSULIN LISPRO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSRENOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142666-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13739BP</companynumb>
    <primarysource>
      <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>DRY MOUTH</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>20091201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DITROPAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLADDER SPASM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DITROPAN</medicinalproduct>
        <drugindication>INCONTINENCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAPACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISORDIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142667-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13228BP</companynumb>
    <primarysource>
      <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>
        <drugindication>DYSPNOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101125</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142668-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13131BP</companynumb>
    <primarysource>
      <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>DYSPNOEA</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>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142669-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-018927-10</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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>020733</drugauthorizationnumb>
        <drugadministrationroute>060</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>020733</drugauthorizationnumb>
        <drugdosagetext>TAPERING DOSES</drugdosagetext>
        <drugadministrationroute>060</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>020733</drugauthorizationnumb>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>DRUG DEPENDENCE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100707</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADONE</medicinalproduct>
        <drugauthorizationnumb>020733</drugauthorizationnumb>
        <drugdosagetext>DOSES VARIED UP TO 140 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG DEPENDENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142670-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-018932-10</companynumb>
    <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>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>022410</drugauthorizationnumb>
        <drugdosagetext>DOSAGE INFORMATION UNKNOWN / SUBLINGUAL FILM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPIOIDS</medicinalproduct>
        <drugauthorizationnumb>022410</drugauthorizationnumb>
        <drugdosagetext>DOSAGE INFORMATION UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142671-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-018807-10</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>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>020732</drugauthorizationnumb>
        <drugdosagetext>DOSING INFORMATION UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>020732</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN DOSING DETAILS</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBUTEX</medicinalproduct>
        <drugauthorizationnumb>020732</drugauthorizationnumb>
        <drugdosagetext>DOSING INFORMATION UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142672-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-018863-10</companynumb>
    <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 EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL DRUGS AFFECTING FOETUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBUTEX</medicinalproduct>
        <drugauthorizationnumb>020732</drugauthorizationnumb>
        <drugdosagetext>DOSING INFORMATION UNKNOWN</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142673-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-018381-10</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>020733</drugauthorizationnumb>
        <drugdosagetext>DOSAGE UNKNOWN AT THIS TIME.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142674-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-015999-10</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>020733</drugauthorizationnumb>
        <drugdosagetext>DOSING INFORMATION UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142675-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-014974-10</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>022410</drugauthorizationnumb>
        <drugdosagetext>DOSING INFORMATION UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE SUBLINGUAL FILM</medicinalproduct>
        <drugauthorizationnumb>022410</drugauthorizationnumb>
        <drugdosagetext>SUBLINGUAL FILM / DOSING INFORMATION UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142676-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-006751-10</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCORIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LACERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>020733</drugauthorizationnumb>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>DRUG DEPENDENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugauthorizationnumb>020733</drugauthorizationnumb>
        <drugdosagetext>DOSING DETAILS UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MOOD SWINGS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142677-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-015717-10</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBSTANCE ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>020733</drugauthorizationnumb>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>020733</drugauthorizationnumb>
        <drugadministrationroute>060</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>020733</drugauthorizationnumb>
        <drugadministrationroute>060</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>020733</drugauthorizationnumb>
        <drugdosagetext>DOSAGE UNKNOWN AT THIS TIME.</drugdosagetext>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>DRUG DEPENDENCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugauthorizationnumb>020733</drugauthorizationnumb>
        <drugdosagetext>DOSING INFORMATION UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142678-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0034163</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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101129</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142679-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GENENTECH-310306</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRECANCEROUS SKIN LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCOMITANT DRUGS</medicinalproduct>
        <drugindication>RESPIRATORY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142680-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033783</companynumb>
    <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>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080811</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142681-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-GENENTECH-307204</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS LIMB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNODEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100505</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METICORTEN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METICORTEN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>.5 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZULFIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELESTAMINE TAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>6 MG, UNK</drugdosagetext>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>750 MG, UNK</drugdosagetext>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142682-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GENENTECH-309805</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC ANEURYSM RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GRTPA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101006</drugenddate>
        <drugtreatmentduration>63</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCOMITANT DRUG</medicinalproduct>
        <drugdosagetext>200 ML, UNK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEO-MINOPHAGEN C</medicinalproduct>
        <drugdosagetext>20 ML, UNK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TATHION</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142683-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-GENENTECH-296694</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>675 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>1350 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugdosagetext>90 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>25 A?G, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142684-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GILEAD-2010-0033987</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142685-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GENENTECH-297355</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOPULMONARY ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEARING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED UPPER AIRWAY SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>S0077B, S0078B</drugbatchnumb>
        <drugdosagetext>225 MG, Q2W</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090805</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>S0077B, S0078B</drugbatchnumb>
        <drugdosagetext>225 MG, Q2W</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091013</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>375 MG, Q2W</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>S0078B</drugbatchnumb>
        <drugdosagetext>225 MG, Q2W</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>S0078B</drugbatchnumb>
        <drugdosagetext>225 MG, Q2W</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>225 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALVESCO</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNIPHYL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142686-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20081020</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-GENENTECH-310752</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142687-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-ABBOTT-10P-055-0686336-00</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLACID TABLETS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugdosagetext>500 MILLIGRAMS, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXIMED</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>150 MILLIGRAMS, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugdosagetext>1X1</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142688-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-10P-087-0651236-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPLIN SR FOR INJECTION 11.25 MG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020708</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BICALUTAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER STAGE IV</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLADDERON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NOCTURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080708</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142689-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SG-ABBOTT-10P-141-0685285-00</companynumb>
    <primarysource>
      <reportercountry>SINGAPORE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>E.E.S. 400</medicinalproduct>
        <drugbatchnumb>B6008225</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICLOSAN WASH</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICLOSAN WASH</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100802</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICLOSAN WASH</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100802</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZOYL PEROXIDE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100211</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142690-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SG-ABBOTT-10P-141-0686145-00</companynumb>
    <primarysource>
      <reportercountry>SINGAPORE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>E.E.S. 400</medicinalproduct>
        <drugbatchnumb>B6008225</drugbatchnumb>
        <drugauthorizationnumb>061905</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICLOSAN WASH</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICLOSAN WASH</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100802</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICLOSAN WASH</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
        <drugdosagetext>GEL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100802</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
        <drugdosagetext>GEL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZOYL PEROXIDE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
        <drugdosagetext>GEL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100211</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142691-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-10P-028-0662089-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPRON DEPOT</medicinalproduct>
        <drugbatchnumb>807962E21</drugbatchnumb>
        <drugauthorizationnumb>020517</drugauthorizationnumb>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100512</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142692-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-10P-020-0675240-00</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOCTURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugbatchnumb>79379QA</drugbatchnumb>
        <drugauthorizationnumb>018723</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GARDENAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN ASPARTAME</medicinalproduct>
        <drugdosagetext>ACCORDING TO GLUCOSE ALTERATION</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142693-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-10P-087-0686990-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPLIN SR FOR INJECTION 11.25 MG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020708</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090804</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BICALUTAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090528</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMAC D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090811</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090819</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142694-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-10P-028-0684734-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>46.308</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAKTHROUGH PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>DAILY AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEVA-HYDROXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APO-SALVENT</medicinalproduct>
        <drugdosagetext>TWICE A DAY AS NEEDED</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DYSPNOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APO-LORAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEVA-TRAZODONE</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIOLYTIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APO-PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APO-PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICOCIN</medicinalproduct>
        <drugdosagetext>1 SPRAY TWICE DAILY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>EVERY 72 HOURS AS NEEDED</drugdosagetext>
        <drugadministrationroute>062</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>LITHANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142695-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041004</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-GENENTECH-310712</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142696-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GENENTECH-286118</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>CYTOMEGALOVIRUS CHORIORETINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITRECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANIBIZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>0.05 ML, UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1.25 MG, UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090323</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMCINOLONE ACETONIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090213</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142697-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033234</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>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101104</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142698-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0034158</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>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142699-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH027735</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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 FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142700-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010007380</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>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>70 A?G, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100427</drugenddate>
        <drugtreatmentduration>135</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142701-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0034173</companynumb>
    <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>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091019</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142702-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ABBOTT-10P-013-0689464-00</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM OF AMPULLA OF VATER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142703-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-10P-056-0688187-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL APLASIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142704-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-10P-056-0683249-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FANCONI SYNDROME ACQUIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCREATININAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBULOINTERSTITIAL NEPHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAXY</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101013</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100823</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANXENE</medicinalproduct>
        <drugdosagetext>1 TAB IN MORNING AND NOON; 2 TAB EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERSYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOLIPRANE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROPLEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAROXYL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142705-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-10P-087-0689579-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>PROSTATE CANCER STAGE IV</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPLIN SR FOR INJECTION 11.25 MG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020708</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPLIN SR FOR INJECTION 11.25 MG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020708</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080706</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BICALUTAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER STAGE IV</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070730</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BICALUTAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRAMUSTINE PHOSPHATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080331</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRAMUSTINE PHOSPHATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080706</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080706</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLLAKISU</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTONIC BLADDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080706</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL ARTERIOSCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080706</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGLAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080706</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080706</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOSUXACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CYSTITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070406</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070406</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142706-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7027539</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>APPENDICITIS PERFORATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>HEART RATE IRREGULAR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PALPITATIONS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142707-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-10P-062-0688243-00</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>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIVERTEBRA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL ATRESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINE MALFORMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022417</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RALTEGRAVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABACAVIR SULFATE LAMIVUDINE AND ZIDOVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARUNAVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142708-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ABBOTT-10P-144-0688556-00</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBILIRUBINAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugdosagetext>GASTRO-RESISTANT TABLET, 3 TIMES A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMOZOLOMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>EXTENDED RELEASE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTECORTIN</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>7142709-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0034003</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>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091125</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142710-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0034177</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091202</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142711-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0034058</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>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090129</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142712-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0034046</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>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142713-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL263809</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BACK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCLERAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P113665</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1021298</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TREXALL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142714-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GENENTECH-304866</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>300 MG, 1/MONTH</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090826</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>BRONCHITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</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>SINGULAIR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSEC (CANADA)</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>ALVESCO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENAZPRINE</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>NORVASC</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>ZESTRIL</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>D-TUBOCURARINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142715-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-WATSON-2010-15492</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>LIVER INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORPROMAZINE HCL</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>080365</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142716-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-WATSON-2010-15450</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>076984</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101015</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADCAL-D3</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIMATOPROST AND TIMOLOL MALEATE</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>PREDNISOLONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142717-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-WATSON-2010-15493</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>LIVER INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALORA</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>020655</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142718-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-WATSON-2010-15442</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>076685</drugauthorizationnumb>
        <drugdosagetext>40 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRIDAMOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142719-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-WATSON-2010-15572</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDONE</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>077860</drugauthorizationnumb>
        <drugdosagetext>SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugdosagetext>SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugdosagetext>SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUETIAPINE FUMARATE</medicinalproduct>
        <drugdosagetext>SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142720-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-WATSON-2010-15495</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TICLOPIDINE HCL</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>075309</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>AZOTAEMIA</drugindication>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142721-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-WATSON-2010-15494</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>LIVER INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORPROMAZINE HCL</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>080365</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142722-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-WATSON-2010-15473</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEEDING DISORDER NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR SUCKING REFLEX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>075662</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>063</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142723-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-WATSON-2010-14227</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PROLACTIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>076928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMISULPRIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101004</drugenddate>
        <drugtreatmentduration>3683</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142724-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GENENTECH-310330</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</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>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1 G, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUPUS NEPHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101015</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUPUS NEPHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101012</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFACALCIDOL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>.25 A?G, QAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>10 MG, QAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>30 A?G, 1/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUPUS NEPHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISEDRONATE SODIUM</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>35 MG, 1/WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142725-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-309152</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>10.884</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142726-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-99P-087-0540558-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENOSYNOVITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPRORELIN DEPOT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020708</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPRORELIN DEPOT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020708</drugauthorizationnumb>
        <drugindication>METASTASES TO LUNG</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXIFLURIDINE</medicinalproduct>
        <drugbatchnumb>UNK,UNK</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXIFLURIDINE</medicinalproduct>
        <drugbatchnumb>UNK,UNK</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991113</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142727-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0688741-00</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>BEZOAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TABLETS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>50 TABS OF 324 MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142728-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-10P-020-0673201-00</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142729-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-08P-087-0460041-00</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019732</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER STAGE II</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070605</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019732</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019732</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER STAGE II</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070313</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070402</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070729</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN 70/30</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070312</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN 70/30</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070313</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN 70/30</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071028</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142730-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0688720-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>ACUTE HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATORENAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>60 ENTERIC-COATED TABLETS OVER 4 HRS</drugdosagetext>
        <drugindication>INTENTIONAL OVERDOSE</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142731-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GENENTECH-310471</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>VENOUS THROMBOSIS LIMB</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>375 MG/M2, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142732-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0034081</companynumb>
    <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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142733-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GENENTECH-310203</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>COLON CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>600 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLD TYPE HAEMOLYTIC ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090606</drugenddate>
        <drugtreatmentduration>47</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>600 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091028</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>600 MG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>600 MG, Q4W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPECIAFOLDINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANZOR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIASCLEDINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142734-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033999</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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090507</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142735-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-282635</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>121</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</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>20090501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091210</drugenddate>
        <drugtreatmentduration>222</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DYSPNOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugdosagetext>2 PUFF, BID</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugdosagetext>300 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091029</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugdosagetext>150 UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090810</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142736-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-GENENTECH-310507</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANIBIZUMAB</medicinalproduct>
        <drugbatchnumb>122655</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>DIABETIC RETINAL OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
        <drugtreatmentduration>694</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142737-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US82698</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>33</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA (IN REMISSION)</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142738-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US76438</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IMMUNOGLOBULIN G ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEM CELL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>750 MG/ DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPEUTICS NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142739-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2009US66500</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITRICIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142740-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010VE81143</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</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>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG/ YEAR</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142741-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010DE17649</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMULECT</medicinalproduct>
        <drugdosagetext>20 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMULECT</medicinalproduct>
        <drugdosagetext>20 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142742-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US82381</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142743-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010AU79697</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>BONE MARROW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1500 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1000 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142744-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010FR81441</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142745-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CL68582</companynumb>
    <primarysource>
      <reportercountry>CHILE</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 SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142746-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US80939</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>2000 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142747-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2010GB05628</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>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONATE</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugindication>SPINAL FRACTURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100602</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142748-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010MX46717</companynumb>
    <primarysource>
      <reportercountry>MEXICO</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>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>1 APPLICATION (5MG/100ML)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142749-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US82157</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>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEOPLASM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142750-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US80008</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAT TISSUE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>2500 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142751-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA66124</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100915</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142752-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US54715</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY SLEEP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SICKLE CELL ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142753-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010MX46643</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
    </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>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>(5 MG/100ML) PER YEAR</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080820</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142754-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010TR80377</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>1</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>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142755-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-GILEAD-E2B_00000970</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>33</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugauthorizationnumb>021356</drugauthorizationnumb>
        <drugdosagetext>245 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREZISTA</medicinalproduct>
        <drugdosagetext>600 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugdosagetext>100 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISENTRESS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOPOXID DAK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETOXAZOL WITH TRIMETOPRIM SAD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142756-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0034045</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142757-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0034055</companynumb>
    <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>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100325</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142758-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-10P-028-0689318-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60.382</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT ELEVATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142759-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-10P-028-0689544-00</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>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142760-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-JPNCT2010007477</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANITUMUMAB</medicinalproduct>
        <drugdosagetext>6 MG/KG, Q2WK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100811</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100813</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100813</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100813</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM LEVOFOLINATE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100813</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON HCL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECTOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142761-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-GENENTECH-310201</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1000 MG, X2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUPUS VASCULITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142762-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-310716</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>GUILLAIN-BARRE SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142763-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GENENTECH-310579</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090727</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142764-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-10P-056-0676468-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>1.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONGENITAL PULMONARY VALVE ATRESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL TRICUSPID VALVE ATRESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION VENTRICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPOPLASIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020945</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142765-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-10P-062-0669213-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CLEFT LIP AND PALATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142766-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-10P-028-0689353-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN XL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050775</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE HYDOROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142767-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101108539</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ATYPICAL MYCOBACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNOSUPPRESSIVE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142768-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033967</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>LIMB OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080814</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142769-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-10P-028-0689325-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN XL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050775</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142770-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ALLERGAN-1015567US</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>BENIGN INTRACRANIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRED FORTE</medicinalproduct>
        <drugauthorizationnumb>017011</drugauthorizationnumb>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EQUASYM</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AUTISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EQUASYM</medicinalproduct>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugdosagetext>0.25 MG, BID</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VEXOL</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142771-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-MERCK-1012USA01027</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ODYNOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugauthorizationnumb>021762</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100519</drugenddate>
        <drugtreatmentduration>57</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142772-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1012USA00177</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>JAW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142773-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-1012GBR00024</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>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142774-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-1011USA01441</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142775-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0805USA00731</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>93</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHAPPED LIPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL PROSTHESIS USER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASOMOTOR RHINITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050613</drugenddate>
        <drugtreatmentduration>3007</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070402</drugenddate>
        <drugtreatmentduration>659</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142776-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-MERCK-1011NLD00002</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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 INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN STEARATE</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142777-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-1009GBR00073</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>162</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CUTANEOUS VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDERNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100908</drugenddate>
        <drugtreatmentduration>86</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100825</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100330</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142778-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-1007DEU00104</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>AVULSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COELIAC DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCHROMIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TESTICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SEASONAL ALLERGY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142779-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CV-MERCK-1011USA03503</companynumb>
    <primarysource>
      <reportercountry>CAPE VERDE</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>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ODYNOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugauthorizationnumb>021762</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100519</drugenddate>
        <drugtreatmentduration>57</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142780-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0911USA04613</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>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALCOHOL ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATROPHIC VULVOVAGINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST COMPLICATION ASSOCIATED WITH DEVICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAPSULAR CONTRACTURE ASSOCIATED WITH BREAST IMPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DACRYOSTENOSIS ACQUIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES HARD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE NONUNION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED TENDENCY TO BRUISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPEN ANGLE GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEASONAL ALLERGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021126</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19640101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080814</drugenddate>
        <drugtreatmentduration>841</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142781-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1001USA03808</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADJUSTMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DENSITY INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED ACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISBACTERIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURED COCCYX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURED SACRUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA FACIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMAGNESAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHOSPHATAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SPRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE STRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL SEPTUM DEVIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEPTIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIORBITAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE FEVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE MENOPAUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL FISSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKULL MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENOSYNOVITIS STENOSANS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG 1 X WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOSCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991201</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG 1 X WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090512</drugenddate>
        <drugtreatmentduration>151</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000601</drugenddate>
        <drugtreatmentduration>392</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG 1 X WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCALCAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991201</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG 1 X WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090512</drugenddate>
        <drugtreatmentduration>151</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000601</drugenddate>
        <drugtreatmentduration>392</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010920</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142782-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GILEAD-E2B_00000896</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>124</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBRISENTAN</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBRISENTAN</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCIAVAT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142783-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033639</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>SICK SINUS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100128</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142784-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033568</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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101112</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142785-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CM-GILEAD-2010-0034041</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLACENTA PRAEVIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATRIPLA</medicinalproduct>
        <drugauthorizationnumb>021937</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPINAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100614</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142786-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7023434</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>ALCOHOL WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081119</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142787-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010005255</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>NEULASTA</medicinalproduct>
        <drugbatchnumb>1009187</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090824</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142788-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU443042</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>170 A?G, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101021</drugenddate>
        <drugtreatmentduration>71</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROID NOS</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</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>NEXIUM</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>POTASSIUM CHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142789-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010005322</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100916</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142790-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010000160</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugbatchnumb>1021478</drugbatchnumb>
        <drugdosagetext>68 A?G, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
        <drugtreatmentduration>39</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAPER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142791-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU432026</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>180 A?G, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100223</drugenddate>
        <drugtreatmentduration>58</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100503</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNOGLOBULINS</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081104</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142792-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010000548</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>10 A?G/KG, UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090708</drugenddate>
        <drugtreatmentduration>72</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090418</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNOGLOBULINS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090423</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090425</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142793-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-AMGEN-AUSSP2010001470</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugbatchnumb>1013848</drugbatchnumb>
        <drugdosagetext>325MCG</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100625</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugbatchnumb>1018119</drugbatchnumb>
        <drugdosagetext>625MCG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugbatchnumb>1020843</drugbatchnumb>
        <drugdosagetext>500MCG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAZOSIN HCL</medicinalproduct>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTELIN                            /00107901/</medicinalproduct>
        <drugdosagetext>1000 A?G, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAPSONE</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE                           /00108001/</medicinalproduct>
        <drugdosagetext>600 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugdosagetext>600 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142794-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010000577</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>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>83 A?G, UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090412</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090410</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142795-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010005391</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>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>2.6 MG, 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>ATENOLOL</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142796-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7030128</companynumb>
    <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>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PITUITARY TUMOUR RECURRENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091130</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142797-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-233222J09USA</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>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICTURITION URGENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOTOR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</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>20090825</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>AMNESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMANTADINE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>FATIGUE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142798-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-GBRCT2010005147</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DENOSUMAB</medicinalproduct>
        <drugdosagetext>1 ML, Q6MO</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080208</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142799-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AMGEN-FRASP2010004882</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142800-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010005606</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>1 A?G/KG, UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091028</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142801-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-FRASP2010004881</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142802-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010005353</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HELICOBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090506</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090519</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
        <drugindication>HELICOBACTER INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142803-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010005351</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>NPLATE</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DANAZOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142804-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010005365</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>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>6 A?G/KG, UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100610</drugenddate>
        <drugtreatmentduration>189</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNOGLOBULINS</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142805-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010003254</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>350 A?G, UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100308</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100122</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142806-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU442217</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>
      <reaction>
        <reactionmeddrapt>HAEMATOLOGICAL MALIGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>500 A?G, UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100812</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROID NOS</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNOGLOBULINS</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142807-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USACT2010005286</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>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, Q2WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142808-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010005372</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>NPLATE</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090605</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142809-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010005394</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>NPLATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142810-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010122425</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>59</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELECOX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NU LOTAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERURICAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHINITIS ALLERGIC</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RINLAXER</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SPINAL OSTEOARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142811-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2010147870</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>
      <patientweight>85.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>600 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080920</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>80 UG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KOGENATE</medicinalproduct>
        <drugdosagetext>2000 IU, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142812-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-FR-WYE-G01379708</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>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080119</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugdosagetext>500 MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080118</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142813-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-FR-WYE-G01013108</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS PNEUMOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugauthorizationnumb>020589</drugauthorizationnumb>
        <drugdosagetext>22.5 KG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071227</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugdosagetext>1 DF, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071227</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>150 MG PER KILOGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EAR INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071227</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOLIPRANE</medicinalproduct>
        <drugdosagetext>60 KG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071227</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVENAR</medicinalproduct>
        <drugdosagetext>1 DF, 1X/DAY</drugdosagetext>
        <drugindication>IMMUNISATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070726</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142814-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010164640</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142815-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010140940</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TRIGEMINAL NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>200MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TRIGEMINAL NEURALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142816-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100810</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0656800-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INTRA-UTERINE DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STILLBIRTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRISOMY 21</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020945</drugauthorizationnumb>
        <drugdosagetext>200MG DAILY</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021906</drugauthorizationnumb>
        <drugdosagetext>4 TABLETS DAILY</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100513</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARUNAVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1200MG DAILY</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARUNAVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1200MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMTRICITABINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>200MG DAILY</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100323</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RALTEGRAVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>800MG DAILY</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100323</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>300MG DAILY</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100513</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE + ZIDOVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>2 DOSAGE FORMS DAILY</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100514</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142817-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GENENTECH-298711</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>36.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH BREATHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER AIRWAY OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>300 MG, Q2W</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>S0078A</drugbatchnumb>
        <drugdosagetext>300 MG, Q2W</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091127</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>S0079</drugbatchnumb>
        <drugdosagetext>300 MG, Q2W</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100319</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090513</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugdosagetext>400 MG, 7/WEEK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142818-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GENENTECH-310573</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>67</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100520</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
        <drugdosagetext>30 MG, QAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>15 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142819-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100512</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GENENTECH-310503</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHRONIC LYMPHOCYTIC LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142820-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071004</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GENENTECH-310498</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142821-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-FR-WYE-G03136109</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOTONSILLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>200 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081215</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugdosagetext>250 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHARYNGOTONSILLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081213</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>500 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081215</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142822-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010159979</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</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>HEAD DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>020151</drugauthorizationnumb>
        <drugdosagetext>75 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>020151</drugauthorizationnumb>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142823-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-FR-WYE-G02884209</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>HEPATITIS CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>1 DF, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000829</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELESTONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000827</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZINNAT</medicinalproduct>
        <drugdosagetext>250 MG, 4X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000829</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugdosagetext>250 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000825</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142824-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010159704</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>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugauthorizationnumb>020882</drugauthorizationnumb>
        <drugdosagetext>200 MG, 4X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100222</drugenddate>
        <drugtreatmentduration>2979</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>2.1 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100222</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>0.5 MG/HOUR CONTINUOUSLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100222</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100222</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100222</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142825-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160326</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>77.098</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>020151</drugauthorizationnumb>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MILNACIPRAN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>0.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142826-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-GENENTECH-307248</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100501</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>6 MG, UNK</drugdosagetext>
        <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>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETODOLAC</medicinalproduct>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOTAN</medicinalproduct>
        <drugdosagetext>3 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM/VITAMIN D</medicinalproduct>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142827-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GENENTECH-310496</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>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142828-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070822</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GENENTECH-310495</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>
      <reaction>
        <reactionmeddrapt>HEPATITIS B</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142829-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-GENENTECH-308737</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITRECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>0042</drugbatchnumb>
        <drugdosagetext>0.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142830-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-GENENTECH-310311</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</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>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142831-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AMGEN-DEUSP2010004400</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugdosagetext>6 MG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugdosagetext>6 MG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugdosagetext>6 MG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugdosagetext>6 MG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100718</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>260 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>250 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>3000 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142832-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006868</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>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>10 A?G/KG, UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100708</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142833-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2004027188</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD AMYLASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142834-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010128501</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>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>100 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </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>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSCAL</medicinalproduct>
        <drugdosagetext>600 MG, UNK</drugdosagetext>
        <drugindication>BONE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM SILVER</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142835-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010160814</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>25 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPINAL COLUMN STENOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101127</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142836-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PFIZER INC-2010160561</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>150 MG, 3X/DAY, EVERY 8 HOURS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>200 MG, SLOW DISSOLVE, 24 HOUS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE</medicinalproduct>
        <drugdosagetext>9 MG, 2X/DAY AND 2MG AS NEED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXCEDRIN (MIGRAINE)</medicinalproduct>
        <drugdosagetext>2-6PILLS DAILY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142837-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2010160109</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>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>200 MG A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>100 MG A DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAROXYL</medicinalproduct>
        <drugdosagetext>25 MG, 2 TABLETS/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101120</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TETRAZEPAM</medicinalproduct>
        <drugdosagetext>25MG, 0.5 TABLET DAILY IF NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101120</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SKENAN</medicinalproduct>
        <drugdosagetext>20 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SKENAN</medicinalproduct>
        <drugdosagetext>30 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugdosagetext>7.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BROMAZEPAM</medicinalproduct>
        <drugdosagetext>6 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECAPEPTYL</medicinalproduct>
        <drugdosagetext>22.5, 1 INJECTION EVERY 6 MONTHS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BICALUTAMIDE</medicinalproduct>
        <drugdosagetext>50 MG, 1 INJECTION EVERY 4 WEEKS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG, 1 INFUSION EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYPROTERONE</medicinalproduct>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>18 A?G</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>BRONCHIAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAHOR</medicinalproduct>
        <drugdosagetext>10 MG, 1 TABLET A DAY</drugdosagetext>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugdosagetext>400/12 A?G</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>BRONCHIAL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142838-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-PFIZER INC-SE-WYE-G06883510</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE CRUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE GRAFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>150 MG, 2X/DAY</drugdosagetext>
        <drugindication>SOCIAL PHOBIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142839-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010015481</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPIGLOTTIS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSAL ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELECOX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>100 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091206</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELECOX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>35 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091202</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONE-ALPHA</medicinalproduct>
        <drugdosagetext>1 UG,UID/ 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091206</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDIOXA</medicinalproduct>
        <drugdosagetext>100 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091206</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBOFLAVIN TAB</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSOLVAN (LASOLVAN)</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>BRONCHITIS CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142840-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010001018</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>6 A?G/KG, UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100924</drugenddate>
        <drugtreatmentduration>78</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNOGLOBULINS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INTERFERON ALFA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100604</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugdosagetext>17 UNK, QD</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugdosagetext>10 UNK, UNK</drugdosagetext>
        <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>ALBUTEROL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE</medicinalproduct>
        <drugdosagetext>25 MG, PRN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</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>VITAMIN C                          /00008001/</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN                       /00097801/</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>DULCOLAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOTRIMAZOLE</medicinalproduct>
        <drugdosagetext>UNK UNK, PRN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142841-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-AMGEN-ARGSP2010007242</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BASEDOW'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, WEEKLY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100311</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBANDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>150 UNK, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>15 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>15 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142842-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-15419294</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>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>INITIAL DOSE 400MG/M2 250MG/M2:1 IN 1 WEEK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEAD AND NECK CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100909</drugenddate>
        <drugtreatmentduration>101</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEAD AND NECK CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100909</drugenddate>
        <drugtreatmentduration>101</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEAD AND NECK CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100909</drugenddate>
        <drugtreatmentduration>101</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142843-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15422181</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>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142844-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MYLANLABS-2010S1021589</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>65.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
        <drugauthorizationnumb>075472</drugauthorizationnumb>
        <drugdosagetext>AB 30.06.08 1-0-1/2 ;VORHER 5MG D, ZUR ENTLASSUNG ERNEUT 5MG/D UNTER ENGMASCHIGER RR-KONTROLLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLEXANE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XIPAMIDE</medicinalproduct>
        <drugdosagetext>AM 30.06.2008 NEU VERORDNET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080722</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOREM /01036501/</medicinalproduct>
        <drugdosagetext>SEIT 30.06.2008 GESTEIGERT AUF 10 MG/D; VORHER 5 MG/D, ZUR E WIEDER REDUZIERT ANGESETZT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBSTRUCTIVE AIRWAYS DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URBASON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBSTRUCTIVE AIRWAYS DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>OBSTRUCTIVE AIRWAYS DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIANI</medicinalproduct>
        <drugdosagetext>1 DF = 50?G SALMETEROL/250?G FLUTICASON</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>OBSTRUCTIVE AIRWAYS DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142845-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-14934327</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>57</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>CETUXIMAB 5MG/ML RECENT INF:8DEC09 ALSO TOOK 397.5MG 09APR2010 DISCONT</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEAD AND NECK CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090911</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEAD AND NECK CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091208</drugenddate>
        <drugtreatmentduration>88</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>RECENT INF:8DEC09 6360MG/4DAYS (1000 MG/M2 AS CONT. INF FROM D1-4 OF CYCLE)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEAD AND NECK CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100111</drugenddate>
        <drugtreatmentduration>122</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIRUDOID</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DRY SKIN PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALMETA</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>RASH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100702</drugenddate>
        <drugtreatmentduration>271</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAMOFA</medicinalproduct>
        <drugdosagetext>GAMOFA D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYSER</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>RASH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100702</drugenddate>
        <drugtreatmentduration>271</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOSIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100409</drugenddate>
        <drugtreatmentduration>206</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMITT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100409</drugenddate>
        <drugtreatmentduration>206</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142846-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MY-BRISTOL-MYERS SQUIBB COMPANY-15295512</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>44</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>INF:1;STRENGTH:5MG/ML.REC.INF ON 07SEP2010. INTERRUPTED ON 21SEP10 RESTART 19OCT10</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>1ST AND REC.INF ON 07SEP10.INTERRUPTED ON 21SEP10;07-21SEP10(14DAYS).RESTARTED ON 19OCT10.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>400MG/M2BOLUS,2400MG/M2CONTINUOUS INF;46HRS REC.INF ON7SEP10;07-21SEP10(14DAYS).RESTARTED ON 19OCT10</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
        <drugdosagetext>1ST AND REC.INF ON 07-SEP-2010.07-21SEP10(14DAYS)INTERRUPTED ON 21SEP10.RESTARTED ON 19OCT10</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100912</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYOSCINE HBR HYT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100912</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100922</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRACET</medicinalproduct>
        <drugdosagetext>ULTRACET 325</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100914</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142847-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-15349905</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIPIPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>DOSE REDUCED TO 375 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100729</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>DOSE REDUCED TO 375 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100729</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugindication>DEPRESSED MOOD</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142848-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-BRISTOL-MYERS SQUIBB COMPANY-15213267</companynumb>
    <primarysource>
      <reportercountry>DENMARK</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>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>TABS</drugdosagetext>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>20MG COATED TABS</drugdosagetext>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>MIRTAZAPIN KRKA</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091104</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142849-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15391246</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCHIZOPHRENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>INITIATED AT 15MG</drugdosagetext>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142850-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MYLANLABS-2010S1021590</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>89.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISOPROLOL</medicinalproduct>
        <drugauthorizationnumb>075831</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARCOXIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080503</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugdosagetext>1 EINZELDOSIS ENTHALT BUDESONID 160 ?G, FORMOTEROLHEMIFUMARAT 4,5 ?G</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142851-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-MYLANLABS-2010S1021596</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>075685</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142852-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AMGEN-FRASP2010006889</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>POLYNEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142853-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AMGEN-FRASP2010005655</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGAMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</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>20100326</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142854-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7030260</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030318</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142855-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7030378</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>REBIF</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142856-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MYLANLABS-2010S1021609</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
        <drugauthorizationnumb>078855</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
        <drugauthorizationnumb>078855</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
        <drugauthorizationnumb>078855</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100922</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142857-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MYLANLABS-2009S1006676</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISOPROLOL</medicinalproduct>
        <drugauthorizationnumb>075831</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>400-0-500 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARTIAL SEIZURES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARTIAL SEIZURES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TICLOPIDINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBELLAR INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142858-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BRISTOL-MYERS SQUIBB COMPANY-14899082</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>62</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>MOST RECENT DOSE ON 10DEC09.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEAD AND NECK CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091210</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEAD AND NECK CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CILENGITIDE</medicinalproduct>
        <drugdosagetext>MOST RECENT INFUSION  ON 10DEC09.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEAD AND NECK CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091210</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>CONTINOUS INFUSION FROM DAY 1 TO DAY 4 OF CYCLE (168MG/M2).</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEAD AND NECK CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091207</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIOSTENOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19640101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142859-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MYLANLABS-2009S1003679</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>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>FURORESE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL IMPAIRMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISOPROLOL</medicinalproduct>
        <drugauthorizationnumb>075831</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEROTEC</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYNEUROPATHY ALCOHOLIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREGABALIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYNEUROPATHY ALCOHOLIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIFROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYNEUROPATHY ALCOHOLIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FALITHROM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY EMBOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142860-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MYLANLABS-2009S1003679</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>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>FURORESE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL IMPAIRMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugauthorizationnumb>040735</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>BISOPROLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEROTEC</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYNEUROPATHY ALCOHOLIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREGABALIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYNEUROPATHY ALCOHOLIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIFROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYNEUROPATHY ALCOHOLIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FALITHROM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY EMBOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142861-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MYLANLABS-2010S1006342</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugauthorizationnumb>065195</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRABECTEDIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRABECTEDIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091202</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>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLIZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</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>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142862-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-AMGEN-NLDSP2010006694</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100602</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142863-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MYLANLABS-2010S1021611</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>OBSESSIVE THOUGHTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>077037</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZAPAIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101005</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142864-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MYLANLABS-2010S1021611</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>OBSESSIVE THOUGHTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>077042</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZAPAIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101005</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142865-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-AMGEN-NLDSP2010007362</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, WEEKLY</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101004</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142866-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MYLANLABS-2010S1021611</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>OBSESSIVE THOUGHTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>077039</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZAPAIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101005</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142867-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AMGEN-DEUSP2010005539</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLEPHARITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KERATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>FOR YEARS 25 MG EVERY TWO WEEKS</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142868-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MYLANLABS-2010S1021640</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugauthorizationnumb>090868</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRIDAMOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142869-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-AMGEN-FINSP2010005207</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUSTULAR 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>20100501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugdosagetext>HALF DOSE</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142870-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-JPNSP2010005000</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142871-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-JPNSP2010004653</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HIP ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBCUTANEOUS ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION STAPHYLOCOCCAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100625</drugenddate>
        <drugtreatmentduration>45</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugdosagetext>8 MG, WEEKLY</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>2 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142872-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-AMGEN-NLDSP2010005229</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OSTEODYSTROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>COLITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142873-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-JPNSP2010006198</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2X/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101115</drugenddate>
        <drugtreatmentduration>251</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugdosagetext>8 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugdosagetext>10 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPALMON</medicinalproduct>
        <drugdosagetext>1 DF, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090831</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142874-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-JPNSP2010005412</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2X/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100921</drugenddate>
        <drugtreatmentduration>810</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugdosagetext>5 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSAID'S</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142875-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-28708</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142876-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090806</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-28754</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142877-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090803</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-28710</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142878-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090806</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-28751</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142879-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090814</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-28731</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142880-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-28707</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142881-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090805</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-28749</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142882-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090831</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-28790</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142883-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090820</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-28706</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142884-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090914</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2009-28785</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7142885-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100406</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2009-29988</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>ILOPROST INHALATION SOLUTION UNKNOWN US</medicinalproduct>
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        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
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        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT LOSS POOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090429</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTASIS</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REPLIVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7143987-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2009BI032260</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>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090818</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7143988-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI009174</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALCOHOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM DIFFICILE COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIV TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNE RECONSTITUTION SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IMPULSIVE BEHAVIOUR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARANOIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7143989-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI017032</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080507</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7143990-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI018896</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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</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>20090729</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7143991-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI023854</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>PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugbatchnumb>P68094</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100721</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7143992-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BIOGENIDEC-2010BI025564</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>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100414</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAIVOBET</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7143993-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI027572</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080425</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVICOR</medicinalproduct>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100809</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7143994-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI028173</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>IMMUNE RECONSTITUTION SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITH NERVE PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>VITAMIN D DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7143995-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI031644</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROMYELITIS OPTICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NEURITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REBOUND EFFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091230</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100709</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7143996-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-BIOGENIDEC-2010BI034262</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TESTICULAR SEMINOMA (PURE)</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugbatchnumb>100202102012</drugbatchnumb>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7143997-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI036190</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</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>20090226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101006</drugenddate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7143998-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI037460</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </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>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100723</drugenddate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7143999-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI038652</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECUBITUS ULCER</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>20100713</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144000-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI038779</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>20080108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144001-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI039965</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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061102</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144002-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-BIOGENIDEC-2010BI040259</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>FEBRILE CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UROSEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugbatchnumb>P68096</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100203</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144003-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI040267</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>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060925</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144004-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041677</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>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080711</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144005-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BIOGENIDEC-2010BI041863</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144006-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041936</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>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugindication>CONVULSION</drugindication>
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        <drugstartdate>20081001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NUVIGIL</medicinalproduct>
        <drugindication>FATIGUE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>7144007-2</safetyreportid>
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    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
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    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GALLBLADDER OPERATION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
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        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071102</drugstartdate>
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        <drugenddate>20101129</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
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        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
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    </patient>
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  <safetyreport>
    <safetyreportid>7144008-4</safetyreportid>
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      <reportercountry>NORWAY</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
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      <reaction>
        <reactionmeddrapt>COMPLICATION OF DELIVERY</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
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        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090818</drugstartdate>
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    </patient>
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  <safetyreport>
    <safetyreportid>7144009-6</safetyreportid>
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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>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE BREAKAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR VERTEBRAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</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>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144010-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI023852</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144011-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI029544</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>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144012-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI038944</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>83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32135</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144013-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI039823</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>
      <patientweight>144</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULATION FACTOR VIII LEVEL ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144014-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI039907</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>FOOD ALLERGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMEMBRANOUS COLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32120</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100829</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020829</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144015-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI040493</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>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144016-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI040593</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>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144017-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BIOGENIDEC-2010BI041772</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144018-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BIOGENIDEC-2010BI041789</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>
      <patientweight>48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND SECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRON BETA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METODOC 50 MG</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144019-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042056</companynumb>
    <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>AVONEX</medicinalproduct>
        <drugbatchnumb>P32121</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144020-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042064</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>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32120</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144021-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042070</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>CLAVICLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURED SACRUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144022-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042085</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050729</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050103</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144023-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042129</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>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144024-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042201</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>GASTROINTESTINAL HYPOMOTILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144025-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042209</companynumb>
    <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>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144026-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042225</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>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS (NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144027-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042235</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>OESOPHAGEAL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144028-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042318</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>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144029-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI023854</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>PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugbatchnumb>P68094</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100721</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144030-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI028173</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>IMMUNE RECONSTITUTION SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITH NERVE PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>VITAMIN D DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144031-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI034871</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070222</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144032-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI036190</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</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>20090226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101006</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144033-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI038146</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>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144034-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI038723</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>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN WARM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101122</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144035-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI038767</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>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080409</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144036-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI038947</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JC VIRUS TEST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144037-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI039593</companynumb>
    <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 RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144038-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI040268</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>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101106</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144039-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041755</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>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101013</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144040-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041899</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>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100930</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144041-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2009BI037168</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>CATHETER PLACEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090224</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144042-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI039607</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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPYRA</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144043-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI039696</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>91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</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>20030201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144044-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041994</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>GAIT DISTURBANCE</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>20101104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144045-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI041995</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>FEAR OF NEEDLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144046-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042025</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060830</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144047-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101127</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042032</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>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100509</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144048-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042037</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>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071119</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144049-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042038</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>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE 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>20101120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144050-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042039</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>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100903</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144051-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042040</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>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100819</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144052-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042065</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>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144053-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042074</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>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100422</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144054-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042195</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 PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32135</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAIN INJECTIONS (NOS)</medicinalproduct>
        <drugindication>NECK PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090807</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144055-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042197</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 PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031017</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144056-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042226</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>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NEURITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144057-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042245</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 HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144058-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042246</companynumb>
    <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 ALLERGIES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144059-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042254</companynumb>
    <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>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE STRAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101027</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144060-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042258</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>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050704</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144061-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042259</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>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</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>7144062-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042265</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>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19961101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144063-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042274</companynumb>
    <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>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOTOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32135</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100306</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144064-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042276</companynumb>
    <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>20080508</drugstartdate>
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  <safetyreport>
    <safetyreportid>7144065-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI042279</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>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE COATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101121</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC OTC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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    <transmissiondateformat>102</transmissiondateformat>
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    <serious>2</serious>
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    <receivedate>20101208</receivedate>
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    <receiptdate>20101130</receiptdate>
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      <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>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031010</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100913</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
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    <safetyreportid>7144067-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
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    <receivedate>20101208</receivedate>
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    <receiptdate>20061218</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2006-32016</companynumb>
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      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
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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>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
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    </patient>
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  <safetyreport>
    <safetyreportid>7144068-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
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      <reportercountry>UNITED STATES</reportercountry>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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    <patient>
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    <transmissiondateformat>102</transmissiondateformat>
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    <patient>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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    <transmissiondateformat>102</transmissiondateformat>
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      <drug>
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    <transmissiondateformat>102</transmissiondateformat>
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      <drug>
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    <receiver></receiver>
    <patient>
      <patientweight>51</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EAR PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIDOL PM</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ABDOMINAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLINTSTONES COMPLETE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESOGESTREL AND ETHINYL ESTRADIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC-D 12 HOUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>800 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144327-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201041344NA</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>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE + ETHINYLESTRADIOL 20A?G (24+4)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144334-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201038642NA</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>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OCELLA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144336-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201041522NA</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>DROSPIRENONE + ETHINYLESTRADIOL 20A?G (24+4)</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144365-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201023523BCC</companynumb>
    <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>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELMIRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144375-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201041573NA</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>DROSPIRENONE + ETHINYLESTRADIOL 20A?G (24+4)</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144376-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100923</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201022319BCC</companynumb>
    <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>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN PREPARATION + MINERAL SUPPLEMENT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONE A DAY ENERGY</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144390-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100826</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201034731NA</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>MULTIPLE INJURIES</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>YASMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144391-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100826</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201034939NA</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>MULTIPLE INJURIES</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>YASMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144392-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042047NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GALLBLADDER INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144395-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201023352BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66.818</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ISCHAEMIC HEART DISEASE PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144397-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-001243</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>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144398-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-000981</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>GALLBLADDER INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144404-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-001225</companynumb>
    <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 INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144405-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BAYER-2010-001499</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 A?G, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144410-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-BAYER-2010-000710</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100927</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144412-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042136NA</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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNEVIST</medicinalproduct>
        <drugbatchnumb>02026A</drugbatchnumb>
        <drugauthorizationnumb>019596</drugauthorizationnumb>
        <drugdosagetext>14 ML, ONCE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144415-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100610</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201025680NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>130</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BILE DUCT STONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>91637A</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091101</drugenddate>
        <drugtreatmentduration>974</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>91644A</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091101</drugenddate>
        <drugtreatmentduration>974</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144425-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-000353</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>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>213670H</drugbatchnumb>
        <drugauthorizationnumb>021317</drugauthorizationnumb>
        <drugdosagetext>81 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ISCHAEMIC HEART DISEASE PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RALOXIFENE HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144429-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BAYER-201040027GPV</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILOPROST</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILOPROST</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BOSENTAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144430-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201032692NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACTOR V LEIDEN MUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIITH NERVE PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugbatchnumb>83057A</drugbatchnumb>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
        <drugtreatmentduration>213</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144431-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201041071NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50.455</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIARY DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD ALLERGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC POLYPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE INJURIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOMEDIASTINUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>81326A</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENSTRUAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>50 MG (DAILY DOSE), ,</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40 MG (DAILY DOSE), ,</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
        <drugdosagetext>BEFORE MEALS</drugdosagetext>
        <drugindication>VOMITING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugdosagetext>50 MG (DAILY DOSE), BID,</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144432-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BAYER-201047926GPV</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENDOPROST</medicinalproduct>
        <drugbatchnumb>93042B</drugbatchnumb>
        <drugdosagetext>50 A?G (DAILY DOSE), , UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RAYNAUD'S PHENOMENON</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BOSENTAN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE MAGNESIUM</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>40 MG (DAILY DOSE), , ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTOXIFYLLINE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144433-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201041959NA</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>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE INJURIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASYLOL</medicinalproduct>
        <drugauthorizationnumb>020304</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001031</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144435-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100908</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201012522NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANORECTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENITAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRADUCTAL PAPILLOMA OF BREAST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
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        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
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        <drugenddate>20090101</drugenddate>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
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        <drugenddate>20090201</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090501</drugstartdate>
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        <drugenddate>20090801</drugenddate>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OCELLA</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081201</drugstartdate>
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        <drugenddate>20090501</drugenddate>
        <drugtreatmentduration>152</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OCELLA</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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  <safetyreport>
    <safetyreportid>7144437-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <receiptdate>20060504</receiptdate>
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    <receiver></receiver>
    <patient>
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        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
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    <patient>
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    <transmissiondateformat>102</transmissiondateformat>
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    <receiver></receiver>
    <patient>
      <reaction>
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      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
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      <drug>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
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      <senderorganization>FDA-Public Use</senderorganization>
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        <drugauthorizationnumb>021290</drugauthorizationnumb>
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      <senderorganization>FDA-Public Use</senderorganization>
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      <drug>
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        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
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    <transmissiondateformat>102</transmissiondateformat>
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      <reportercountry>UNITED STATES</reportercountry>
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      <senderorganization>FDA-Public Use</senderorganization>
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      <drug>
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        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
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    <transmissiondateformat>102</transmissiondateformat>
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      <reportercountry>UNITED STATES</reportercountry>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
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    <safetyreportid>7144464-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
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      <reportercountry>UNITED STATES</reportercountry>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
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        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
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    <safetyreportid>7144465-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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      <reportercountry>UNITED STATES</reportercountry>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
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  <safetyreport>
    <safetyreportid>7144466-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <companynumb>FR-BAYER-2010-000553</companynumb>
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      <reportercountry>FRANCE</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN SODIUM</medicinalproduct>
        <drugdosagetext>750 MG, QD</drugdosagetext>
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        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELIPROLOL BIOGARAN</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN  AND HYDROCHLOROTHIAZIDE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIVELLE-DOT</medicinalproduct>
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  <safetyreport>
    <safetyreportid>7144469-0</safetyreportid>
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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>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>JAW DISORDER</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>MONOPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
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        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>YA0549A</drugbatchnumb>
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        <drugindication>PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090323</drugstartdate>
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        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>ZA1791A</drugbatchnumb>
        <drugdosagetext>BETAJECT</drugdosagetext>
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        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090807</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>AA0042A</drugbatchnumb>
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      <drug>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE</medicinalproduct>
        <drugdosagetext>3-4 TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKELAXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144470-7</safetyreportid>
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    <receiptdate>20071119</receiptdate>
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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>
      <reaction>
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      </reaction>
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        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
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        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144471-9</safetyreportid>
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    <receiver></receiver>
    <patient>
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        <drugauthorizationnumb>021290</drugauthorizationnumb>
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  <safetyreport>
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    <receiver></receiver>
    <patient>
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      <drug>
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        <drugauthorizationnumb>021290</drugauthorizationnumb>
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        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
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    </patient>
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  <safetyreport>
    <safetyreportid>7144473-2</safetyreportid>
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  <safetyreport>
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  <safetyreport>
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      <drug>
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        <drugadministrationroute>048</drugadministrationroute>
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  <safetyreport>
    <safetyreportid>7144476-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
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    <receiver></receiver>
    <patient>
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        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144477-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080514</receiptdate>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
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    </patient>
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  <safetyreport>
    <safetyreportid>7144478-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
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    <receiptdate>20071121</receiptdate>
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      <qualification>1</qualification>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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      <drug>
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        <drugauthorizationnumb>021290</drugauthorizationnumb>
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        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
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    </patient>
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  <safetyreport>
    <safetyreportid>7144479-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070227</receiptdate>
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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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      <drug>
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        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
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        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
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    </patient>
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  <safetyreport>
    <safetyreportid>7144480-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <receiver></receiver>
    <patient>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugauthorizationnumb>021290</drugauthorizationnumb>
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        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
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  <safetyreport>
    <safetyreportid>7144481-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <receiver></receiver>
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        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
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  <safetyreport>
    <safetyreportid>7144482-3</safetyreportid>
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    <receiver></receiver>
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    <receiptdate>20060901</receiptdate>
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    <receiver></receiver>
    <patient>
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      <drug>
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      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>7144484-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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      <reportercountry>UNITED STATES</reportercountry>
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    <receiver></receiver>
    <patient>
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    </patient>
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  <safetyreport>
    <safetyreportid>7144488-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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      <reportercountry>GERMANY</reportercountry>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
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        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
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  <safetyreport>
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    <receiver></receiver>
    <patient>
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    <receiver></receiver>
    <patient>
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    <safetyreportid>7144492-6</safetyreportid>
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      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144561-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-32761</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144562-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-32292</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144563-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080701</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-32656</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144569-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-001091</companynumb>
    <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 INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144572-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-BAYER-2010-000829</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON BETA-1B</medicinalproduct>
        <drugdosagetext>2 MIU, QOD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERGOCALCIFEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1000 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144574-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>CH-BAYER-2010-000149</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugauthorizationnumb>016030</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE 100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101029</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144577-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100402</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201019760NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>118.18</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADNEXA UTERI MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMBOLISM VENOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESSENTIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MAY-THURNER SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HOT FLUSH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMIG</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNCODEABLE ^UNCLASSIFIABLE^</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNCODEABLE ^UNCLASSIFIABLE^</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144588-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201022387BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.364</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugbatchnumb>258582-01</drugbatchnumb>
        <drugdosagetext>2 DF, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUS HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID({=100 MG)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIOVASCULAR SYSTEM DRUGS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144589-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-001600</companynumb>
    <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 INJURY</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>7144592-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201023298BCC</companynumb>
    <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>DESONATE</medicinalproduct>
        <drugauthorizationnumb>021844</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DERMATITIS ATOPIC</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144593-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-001678</companynumb>
    <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 INJURY</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>7144596-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-001708</companynumb>
    <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 INJURY</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>7144599-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BAYER-2010-000887</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</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>CIPROFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>021473</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144602-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-001623</companynumb>
    <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 INJURY</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>7144605-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-000571</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GALLBLADDER INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144608-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-000610</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GALLBLADDER INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144609-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101121</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-000233</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144611-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201023667BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PARKINSON'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASP EFF SPARK ORIGINAL COLD</medicinalproduct>
        <drugbatchnumb>BTA8Z06</drugbatchnumb>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASAL CONGESTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVODOPA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMTAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144613-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BAYER-2010-000593</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144618-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101128</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-BAYER-2010-000139</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144627-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-000882</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>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>021085</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144632-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201023570BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>120.46</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugbatchnumb>213710H</drugbatchnumb>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144638-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-000846</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>GALLBLADDER INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144639-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-000423</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GALLBLADDER INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144641-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BAYER-2010-000135</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>BETAFERON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144643-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-001112</companynumb>
    <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 INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144644-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201023469BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.636</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION DURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugbatchnumb>10506</drugbatchnumb>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE 2 DF</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH TYLENOL PM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE [GLUCOSAMINE]</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144645-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201023527BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.364</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugbatchnumb>53646</drugbatchnumb>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144646-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-001009</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>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>021085</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144648-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
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    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-000701</companynumb>
    <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 INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144650-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
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    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-000591</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GALLBLADDER INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144651-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201022905BCC</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>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugbatchnumb>207270C</drugbatchnumb>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101022</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144652-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101021</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201022818BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugindication>TOOTHACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144653-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-BAYER-2010-000038</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE 20 MCG/24HR</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE 20 MCG/24HR</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE 20 MCG/24HR</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101122</drugenddate>
        <drugtreatmentduration>181</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144657-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100923</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201022322BCC</companynumb>
    <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>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021317</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144660-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-000853</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>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER NON-FUNCTIONING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OCELLA</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144664-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-000744</companynumb>
    <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 INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144680-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201023568BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.818</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIDOL EXTENDED RELIEF CAPLETS</medicinalproduct>
        <drugbatchnumb>210090E</drugbatchnumb>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>5 DF, 5ID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSMENORRHOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIDOL EXTENDED RELIEF CAPLETS</medicinalproduct>
        <drugbatchnumb>210090E</drugbatchnumb>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>1 DF, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101102</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144681-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-001003</companynumb>
    <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 INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144689-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-TEVA-258209ISR</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugauthorizationnumb>020622</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030210</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144690-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-TEVA-258214ISR</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>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASOCONSTRICTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISOPROLOL</medicinalproduct>
        <drugauthorizationnumb>019982</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100502</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144746-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201023637BCC</companynumb>
    <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>
        <drugdosagetext>DAILY DOSE 1125 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144779-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011007339</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>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>7144780-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201012000098</companynumb>
    <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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A723779C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101019</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144781-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201012000102</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 EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>020815</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144782-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011007627</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144783-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011007564</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>PUBIS FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A745676C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144784-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201011004114</companynumb>
    <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>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DRAINAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144785-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201012000158</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONCUSSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A719441C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101117</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101121</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144786-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201008008723</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>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTEBRAL FORAMINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A713107C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144813-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201012000367</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>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144814-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE201012000417</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144815-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201012000348</companynumb>
    <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>HYPOGLYCAEMIC UNCONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugbatchnumb>A748487A</drugbatchnumb>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>15 U, EACH EVENING</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN N</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101112</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144816-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201012000672</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>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144817-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-ELI_LILLY_AND_COMPANY-TR201012000477</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugbatchnumb>A730450A</drugbatchnumb>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>24 U, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>GESTATIONAL DIABETES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugdosagetext>24 U, 3/D</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>GESTATIONAL DIABETES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
        <drugdosagetext>UNK, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144818-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201012000139</companynumb>
    <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>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144819-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-ELI_LILLY_AND_COMPANY-KR201011007508</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</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>BRONCHIAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG MIX 75/25</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>16 U, 2/D</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER ANTINEOPLASTIC AGENTS</medicinalproduct>
        <drugindication>MYELOMA RECURRENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugindication>MYELOMA RECURRENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAL ANTIDIABETICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144820-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201002003457</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>UNK, 2/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>1000 MG, EACH MORNING</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>500 MG, EACH EVENING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugdosagetext>30 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugindication>CHEST PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>25 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugdosagetext>UNK, EACH MORNING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>20 MEQ, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSAID'S</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144821-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ELI_LILLY_AND_COMPANY-GB201011007485</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144822-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201001003971</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>CHOLANGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANCREASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>35 MG, EACH EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORMAL SALINE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DEHYDRATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050818</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORMAL SALINE</medicinalproduct>
        <drugdosagetext>250 ML/HR</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORMAL SALINE</medicinalproduct>
        <drugdosagetext>1 LITER, UNK</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071221</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORMAL SALINE</medicinalproduct>
        <drugdosagetext>1 LITER, UNK</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071221</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORMAL SALINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090121</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144823-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ELI_LILLY_AND_COMPANY-ES201011007107</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</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>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144824-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR201011007189</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144825-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ELI_LILLY_AND_COMPANY-BR201011005112</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugbatchnumb>A748580C</drugbatchnumb>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>32 IU, EACH MORNING</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugbatchnumb>A748580C</drugbatchnumb>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>4 IU, EACH EVENING</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144826-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201012000223</companynumb>
    <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>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>A695110A</drugbatchnumb>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144827-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201005000733</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>BENIGN PROSTATIC HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTRIGLYCERIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091005</drugenddate>
        <drugtreatmentduration>956</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090902</drugenddate>
        <drugtreatmentduration>891</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090428</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIL SODIUM</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL /USA/</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091119</drugenddate>
        <drugtreatmentduration>966</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE PAMOATE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080515</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144831-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090903</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-CELGENEUS-056-21880-10081783</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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARDEGIC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKENAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEXAQUINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OGASTRO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144832-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-CELGENEUS-028-C5013-10113078</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>020785</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELPHALAN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144834-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE201011006858</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>30 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144835-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ELI_LILLY_AND_COMPANY-AU201011006652</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144836-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-ELI_LILLY_AND_COMPANY-MX201011006886</companynumb>
    <primarysource>
      <reportercountry>MEXICO</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>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>021253</drugauthorizationnumb>
        <drugdosagetext>10 MG,</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101121</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144837-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201011002527</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>40 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144838-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE201011006845</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNS SECOND DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERGENYL</medicinalproduct>
        <drugdosagetext>2 D/F, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIVIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPIPERON</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEROSOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144839-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ELI_LILLY_AND_COMPANY-NL201011003453</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>144</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FOOD CRAVING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100920</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>15 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100926</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>12.5 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101010</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101115</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
        <drugdosagetext>UNK, OTHER</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
        <drugdosagetext>UNK, OTHER</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144840-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ELI_LILLY_AND_COMPANY-GB201011002245</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF INJURIOUS BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>018936</drugauthorizationnumb>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>DEPRESSED MOOD</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugdosagetext>18 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101004</drugenddate>
        <drugtreatmentduration>75</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugdosagetext>27 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144841-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-ELI_LILLY_AND_COMPANY-CH201011002641</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BORDERLINE PERSONALITY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>30 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>50 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144842-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ELI_LILLY_AND_COMPANY-GB201009003559</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NARCOTIC INTOXICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>021253</drugauthorizationnumb>
        <drugdosagetext>5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>021253</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugdosagetext>40 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100904</drugenddate>
        <drugtreatmentduration>38</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBIMAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100822</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugdosagetext>40 MG, 3/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100822</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugindication>HYPERTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100822</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144843-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201006004561</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CLEFT PALATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIAPHRAGMATIC ABNORMAL RELAXATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE CONGENITAL ABNORMALITIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPOPLASIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>7.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100603</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMITT</medicinalproduct>
        <drugdosagetext>990 MG, UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100603</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugdosagetext>600 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090920</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144846-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-CELGENEUS-087-21880-10112826</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100923</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101008</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LENADEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100928</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LENADEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101004</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144847-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-CELGENEUS-056-21880-10112877</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144848-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-CELGENEUS-056-21880-10110594</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>CELL DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS E</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144851-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-CELGENEUS-083-21880-10092543</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOPULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101111</drugenddate>
        <drugtreatmentduration>70</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELPHALAN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101107</drugenddate>
        <drugtreatmentduration>66</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101107</drugenddate>
        <drugtreatmentduration>66</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100902</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144852-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-CELGENEUS-083-21880-10102976</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144859-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101021</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-AMGEN-AUTNI2010001090</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIMPARA</medicinalproduct>
        <drugauthorizationnumb>021688</drugauthorizationnumb>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPARATHYROIDISM SECONDARY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100608</drugenddate>
        <drugtreatmentduration>76</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugdosagetext>60 MG, QWK</drugdosagetext>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100420</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>160 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100319</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICARD</medicinalproduct>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100428</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOMEXOR</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100428</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM ACETATE</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100310</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144869-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2010160067</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>24</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>2 INTAKES A WEEK, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>200 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100512</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JOSACIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYCOPLASMA INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100517</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERFALGAN</medicinalproduct>
        <drugdosagetext>80 MG/KG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100524</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144870-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-CELGENEUS-167-C5013-10112786</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTRACARDIAC THROMBUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CC-5013\PLACEBO</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100826</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CC-5013\PLACEBO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100826</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100825</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101117</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144875-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-12945BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING DRUNK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</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>20101113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHYTAMOL</medicinalproduct>
        <drugdosagetext>650 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHYTAMOL</medicinalproduct>
        <drugindication>ARRHYTHMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>1600 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE RELAXANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIURETIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENAZPRINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDODERM</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144876-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-CELGENEUS-082-21880-10112888</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</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>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144877-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10120591</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>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101014</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144878-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7027474</companynumb>
    <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 PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101026</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INTRAUTERINE DEVICE</medicinalproduct>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144886-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-JNJFOC-20101200569</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</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>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <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>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144887-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161321</companynumb>
    <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>RELPAX</medicinalproduct>
        <drugauthorizationnumb>021016</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144903-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006967</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS FLOATERS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144904-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-JNJFOC-20101200395</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POROKERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMPONI</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144905-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2010SE57253</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>021399</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFASULY</medicinalproduct>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS CITRATE</medicinalproduct>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAC</medicinalproduct>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEZAFIBRATE</medicinalproduct>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMITT</medicinalproduct>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144906-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-TYCO HEALTHCARE/MALLINCKRODT-T201002367</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>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIRAY 350</medicinalproduct>
        <drugbatchnumb>10H1875T</drugbatchnumb>
        <drugauthorizationnumb>019710</drugauthorizationnumb>
        <drugdosagetext>UNK, SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COMPUTERISED TOMOGRAM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144913-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10120412</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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100316</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144914-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10120270</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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144915-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100317</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-ASTRAZENECA-2010SE11802</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7314</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUETIAPINE FUMARATE</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050901</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZTROPINE MESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EXTRAPYRAMIDAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050901</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050901</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144916-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2010SE57294</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>CORONARY ARTERY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAL</medicinalproduct>
        <drugauthorizationnumb>019810</drugauthorizationnumb>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144917-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ASTRAZENECA-2010SE57188</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144918-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-PURDUE-GBR-2010-0007463</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>2 X 5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPINAL FRACTURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101124</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DELTACORTENE</medicinalproduct>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOX</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIATEC                            /00885601/</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
        <drugdosagetext>125 MCG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASELINE                           /00473501/</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144919-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010007576</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>NPLATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144920-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010007005</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1020932</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090402</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144927-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC.-2010-RO-01585RO</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>076504</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>SNORING</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AREDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144928-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ASTRAZENECA-2010SE57131</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144929-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-12993BP</companynumb>
    <primarysource>
      <qualification>2</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>COMBIVENT</medicinalproduct>
        <drugbatchnumb>065571A</drugbatchnumb>
        <drugauthorizationnumb>020291</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144930-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-PURDUE-GBR_2008_0004178</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYNORM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061010</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUNITINIB MALATE</medicinalproduct>
        <drugdosagetext>37.5 MG, DAILY, CYCLIC OD; 4WEEKS ON/2 WEEKS OFF</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060802</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELOZOK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAXOBERAL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULCOLAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM                             /01479303/</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070212</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144931-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-CELGENEUS-087-21880-10101343</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100907</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100819</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LENADEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100823</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LENADEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100907</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUFFERIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100907</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100907</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100907</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144937-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10081509</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>
      <reaction>
        <reactionmeddrapt>METASTATIC MALIGNANT MELANOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-HODGKIN'S LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144938-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10120379</companynumb>
    <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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144939-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>MX-JNJFOC-20081203442</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>39</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CACHEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TMC114</medicinalproduct>
        <drugbatchnumb>7DGL95X</drugbatchnumb>
        <drugauthorizationnumb>021976</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TMC114</medicinalproduct>
        <drugbatchnumb>7DGL95X</drugbatchnumb>
        <drugauthorizationnumb>062477</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FTC</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TMC125</medicinalproduct>
        <drugbatchnumb>7BL8100</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144940-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20100807323</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMPONI</medicinalproduct>
        <drugbatchnumb>03097;03128;03190</drugbatchnumb>
        <drugadministrationroute>058</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>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYOCHRYSINE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POSTMENOPAUSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144941-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>MX-JNJFOC-20081203449</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>39</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CACHEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TMC125</medicinalproduct>
        <drugbatchnumb>7BL8100</drugbatchnumb>
        <drugauthorizationnumb>022187</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TMC125</medicinalproduct>
        <drugbatchnumb>7BL8100</drugbatchnumb>
        <drugdosagetext>PATIENT WAS TAKEN HALF OF THE PRESCRIBED  DOSE DUE TO AN ERROR HE MADE IN TAKING THE MEDICATION.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FTC</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TMC114</medicinalproduct>
        <drugbatchnumb>7DGL95X</drugbatchnumb>
        <drugdosagetext>PATIENT WAS TAKEN HALF OF THE PRESCRIBED  DOSE DUE TO AN ERROR HE MADE IN TAKING THE MEDICATION.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144942-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010159609</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>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLMETEC</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100418</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugauthorizationnumb>019787</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144947-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101106040</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugauthorizationnumb>021346</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>021444</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144948-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20100906277</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADALIMUMAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144949-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20100701400</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>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>CYCLE 8</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER RECURRENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>CYCLE 7</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>CYCLE 6</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>CYCLE 5</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>CYCLE 4</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>CYCLE 3</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>CYCLE 2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugdosagetext>CYCLE 1</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZUNOL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMELTEON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMEDIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144950-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PE-JNJFOC-20101200440</companynumb>
    <primarysource>
      <reportercountry>PERU</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>47</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GOLIMUMAB</medicinalproduct>
        <drugbatchnumb>03504</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GOLIMUMAB</medicinalproduct>
        <drugbatchnumb>03504</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </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>DEFLAZACORT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144951-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>LT-JNJFOC-20101202781</companynumb>
    <primarysource>
      <reportercountry>LITHUANIA</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>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRUSH SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPOLEPT</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144957-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2010SE52829</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>50 MG TWO TIMES A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>50 MG TWO TIMES A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HALLUCINATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</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>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMANTADINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>CONDUCTION DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE PLUS D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMANDA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STOOL SOFTNER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM SILVER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVENTIL</medicinalproduct>
        <drugdosagetext>AS REQUIRED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugdosagetext>AS REQUIRED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugdosagetext>AS REQUIRED</drugdosagetext>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
        <drugdosagetext>AS REQUIRED</drugdosagetext>
        <drugindication>DIZZINESS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144960-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>SE-JNJFOC-20101101434</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSAID, NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144961-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2010SE44266</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>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENDOMETRIAL CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugauthorizationnumb>019726</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100825</drugenddate>
        <drugtreatmentduration>517</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOLVADEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144962-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2010SE56662</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL SENSORY NEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENORETIC 100</medicinalproduct>
        <drugauthorizationnumb>018760</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAK-700</medicinalproduct>
        <drugbatchnumb>100974</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
        <drugtreatmentduration>233</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
        <drugtreatmentduration>233</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMCOR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100505</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144963-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010158052</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZULFIDINE</medicinalproduct>
        <drugauthorizationnumb>007073</drugauthorizationnumb>
        <drugdosagetext>1250 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100905</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIMATIL</medicinalproduct>
        <drugdosagetext>50 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100905</drugenddate>
        <drugtreatmentduration>417</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugdosagetext>200 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100905</drugenddate>
        <drugtreatmentduration>417</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144964-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010112151</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>
      <patientweight>41.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>100 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYALURONATE SODIUM</medicinalproduct>
        <drugdosagetext>25 MG, UNKNOWN/D</drugdosagetext>
        <drugadministrationroute>014</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYSLEE</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CILOSTAZOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUVELA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100809</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144973-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20091200895</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugbatchnumb>0822925</drugbatchnumb>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BORTEZOMIB</medicinalproduct>
        <drugbatchnumb>100731</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORINOSTAT</medicinalproduct>
        <drugbatchnumb>Y1732/X4663</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORINOSTAT</medicinalproduct>
        <drugbatchnumb>Y1732/X4663</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEVALONIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144974-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101201043</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYE LASER SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144975-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101201090</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144976-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101200895</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>MENISCUS LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144977-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20100706039</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>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TARSAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENOSYNOVITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OROPHARYNGEAL PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144979-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20101000892</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugauthorizationnumb>021346</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>1-2 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DELIX PLUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144980-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-BRISTOL-MYERS SQUIBB COMPANY-15419740</companynumb>
    <primarysource>
      <reportercountry>MEXICO</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COAPROVEL TABS 300MG/ 25MG</medicinalproduct>
        <drugauthorizationnumb>020758</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144981-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-14440036</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>63</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO MENINGES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugbatchnumb>07T00679B</drugbatchnumb>
        <drugdosagetext>CHIMERIC ANTI-EGFR MAB. THERAPY START DATE 25AUG08.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081103</drugenddate>
        <drugtreatmentduration>70</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>THERAPY START DATE 25AUG08, 2ND COURSE ON 15SEP08</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080915</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>THERAPY START DATE 25AUG08.2ND COURSE ON 15SEP08</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080915</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>THERAPY START DATE 08SEP08</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080922</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLOX</medicinalproduct>
        <drugdosagetext>1 DOSAGEFORM = 5/325 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080825</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYCLINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080904</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>ALSO TAKEN 40MG QD IV FROM 08NOV08-17NOV08 9DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081117</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugdosagetext>ALSO TAKEN 5 MG 1 IN 8 HR, IV FROM 08NOV08-08NOV08</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144982-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BRISTOL-MYERS SQUIBB COMPANY-15423395</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>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugauthorizationnumb>009218</drugauthorizationnumb>
        <drugdosagetext>1 DF=1 POSOLOGIC UNIT,INTERRUPTED ON 20-OCT-10.</drugdosagetext>
        <drugindication>CARDIAC VALVE PROSTHESIS USER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLEXANE</medicinalproduct>
        <drugdosagetext>6000 IU AXA SOLN FOR INJ. 1 DF=2 POSOLOGIC UNITS. INTERRUPTED ON 30OCT2010.</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FONDAPARINUX SODIUM</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101030</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
        <drugdosagetext>1 DF=1 POSOLOGIC UNIT.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
        <drugdosagetext>1 DF=1 POSOLOGIC UNIT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILATREND</medicinalproduct>
        <drugdosagetext>1 DF=1.5 POSOLOGIC UNIT,25 MG TABS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>1 DF=1 POSOLOGIC UNIT,25 MG TABS</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144983-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-14963284</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>
      <patientweight>47</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>19JUL06-28JAN10,1290D;29JN-06JUN10,4MG,129D;07JN10-ONG,3MG,12JN:28JN10(17D),29JAN-06JUN10 4MG 129DY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100607</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144984-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2010157877</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FUNCTION TEST DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDAREX</medicinalproduct>
        <drugauthorizationnumb>018972</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144985-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2010159195</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA MOUTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
        <drugdosagetext>3 UG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100128</drugenddate>
        <drugtreatmentduration>53</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144986-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-14821268</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>44</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HISTIOCYTOSIS HAEMATOPHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPRYCEL</medicinalproduct>
        <drugauthorizationnumb>021986</drugauthorizationnumb>
        <drugdosagetext>INTERRUPT ON 21APR09 RESTART ON 20MAY AT 50MG 2/1D 100 MG 1/1 D FROM 30JUN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXIPIME</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICAFUNGIN SODIUM</medicinalproduct>
        <drugdosagetext>INJ</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKACIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090408</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B1 TAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMINO ACID + ELECTROLYTES</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLATELETS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090421</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GANCICLOVIR</medicinalproduct>
        <drugdosagetext>FORMULATION: INJ</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSCARNET SODIUM</medicinalproduct>
        <drugdosagetext>FORMULATION INJ,  ALSO 180MG/D FROM02SEP-04OCT09</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090902</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSELTAMIVIR PHOSPHATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
        <drugdosagetext>FORMULATION: INJ</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugdosagetext>FORMULATION: INJ</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAZOBACTAM</medicinalproduct>
        <drugdosagetext>FORMULATION: INJ</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIPERACILLIN</medicinalproduct>
        <drugdosagetext>FORMULATION: INJ</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE SODIUM SUCCINATE</medicinalproduct>
        <drugdosagetext>1G/BODY,FORMULATION: INJ</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091004</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144988-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-15222367</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>34</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKERATOSIS PALMARIS AND PLANTARIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAIL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDREA</medicinalproduct>
        <drugauthorizationnumb>016295</drugauthorizationnumb>
        <drugdosagetext>11JAN2004-17APR2005:500MG,18APR-15MAY2005:1000MG,16MAY05-23JAN06:750MG,24JAN2006-27JUL2010:1000MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYCYTHAEMIA VERA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100727</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENDOXAN</medicinalproduct>
        <drugauthorizationnumb>012142</drugauthorizationnumb>
        <drugindication>POLYCYTHAEMIA VERA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100727</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100727</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER</medicinalproduct>
        <drugdosagetext>TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100727</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100727</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144989-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-15328719</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS B DNA INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BARACLUDE</medicinalproduct>
        <drugauthorizationnumb>021797</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BASEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADEFOVIR DIPIVOXIL KIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144990-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-MYLANLABS-2010S1021669</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>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugbatchnumb>6T0109</drugbatchnumb>
        <drugauthorizationnumb>076258</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugbatchnumb>6S0233</drugbatchnumb>
        <drugauthorizationnumb>076258</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144991-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-BRISTOL-MYERS SQUIBB COMPANY-15358740</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugauthorizationnumb>009218</drugauthorizationnumb>
        <drugdosagetext>INTERRP ON 2009 FOR SOME DAYS AND RESUMED.ADJUSTED ON 23AUG10</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OS-CAL + D</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144992-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15373616</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STENT PLACEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugauthorizationnumb>009218</drugauthorizationnumb>
        <drugindication>MITRAL VALVE REPLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144993-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-BRISTOL-MYERS SQUIBB COMPANY-15375298</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIPIPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>DOSE INCREASED TO 150 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144998-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-BRISTOL-MYERS SQUIBB COMPANY-15375561</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>RECENT DOSE:29DEC09</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEAD AND NECK CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091229</drugenddate>
        <drugtreatmentduration>125</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>RECENT DOSE:28OCT09</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEAD AND NECK CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091028</drugenddate>
        <drugtreatmentduration>63</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>RECENT DOSE:12JAN10</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEAD AND NECK CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100112</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>RECENT DOSE:28OCT09</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEAD AND NECK CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091028</drugenddate>
        <drugtreatmentduration>63</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>RECENT DOSE:02NOV09.GIVEN OVER 5 DAYS. ACTUALLY DAILY DOSE:1400MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEAD AND NECK CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091101</drugenddate>
        <drugtreatmentduration>67</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7144999-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-15378144</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>73</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>ABILIFY TABS 6MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DELUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100925</drugenddate>
        <drugtreatmentduration>95</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100922</drugenddate>
        <drugtreatmentduration>61</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRIZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100923</drugenddate>
        <drugtreatmentduration>94</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TASMOLIN</medicinalproduct>
        <drugdosagetext>TASMOLIN TABLET</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERENACE</medicinalproduct>
        <drugdosagetext>SERENACE TABLET 3 MG.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>SEROQUEL TABS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROHYPNOL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOTAN</medicinalproduct>
        <drugdosagetext>LEXOTAN TAB 2MG.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPROMAZINE HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100922</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145000-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-MX-00285MX</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>ONE DAILY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>020850</drugauthorizationnumb>
        <drugdosagetext>A HALF DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>THREE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101009</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145001-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13328BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC 150</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021698</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145002-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20101108513</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHIATRIC SYMPTOM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020588</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145003-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20101000830</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>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTERED AT INAPPROPRIATE SITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAKTARIN</medicinalproduct>
        <drugbatchnumb>ABF2200</drugbatchnumb>
        <drugauthorizationnumb>017450</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAKTARIN</medicinalproduct>
        <drugbatchnumb>ABF2200</drugbatchnumb>
        <drugauthorizationnumb>017450</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>FUNGAL INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145004-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20101007016</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTIQ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTIQ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1 TO 4 G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORDAZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145005-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20101100316</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>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugdosagetext>350 DF</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZALIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145006-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20101201224</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLUENZA VIRUS VACCINE POLYVALENT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145012-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010001529</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>NPLATE</medicinalproduct>
        <drugdosagetext>62.9 A?G, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091215</drugenddate>
        <drugtreatmentduration>76</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugindication>THROMBOCYTOPENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145013-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010007600</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>NPLATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145014-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MYLANLABS-2010S1021641</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALENDRONIC ACID</medicinalproduct>
        <drugauthorizationnumb>076584</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TEMPORAL ARTERITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADCAL-D3</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIMATOPROST AND TIMOLOL MALEATE</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>PREDNISOLONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145015-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2010SE56666</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>RHINOCORT</medicinalproduct>
        <drugauthorizationnumb>020746</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145019-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7001707</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>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL PM</medicinalproduct>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145021-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10120282</companynumb>
    <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>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145022-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10113046</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>KNEE OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090427</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145023-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-JNJFOC-20101200866</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NARCOTIC INTOXICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugdosagetext>EVERY 3 DAYS AS NEEDED</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUNITINIB MALATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUNITINIB MALATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUNITINIB MALATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUNITINIB MALATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGESTROL ACETATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145024-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101003270</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 3</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
        <drugbatchnumb>G214</drugbatchnumb>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
        <drugbatchnumb>G214</drugbatchnumb>
        <drugdosagetext>16NG/KG/MIN, 30,000NG/ML CONCENTRATION, PUMP RATE 54ML/DAY</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145025-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-235372J09USA</companynumb>
    <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>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030602</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145026-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7014246</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN NEOPLASM BENIGN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145027-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-430049K09USA</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>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVANTRONE</medicinalproduct>
        <drugauthorizationnumb>019297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145028-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7029930</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101030</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145029-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7021913</companynumb>
    <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>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NEURITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145030-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BRISTOL-MYERS SQUIBB COMPANY-15419450</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORENCIA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTELOS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>1DF=300 UNITS NOT GIVEN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091217</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145031-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060607</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2006NL02726</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145032-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MYLANLABS-2010S1021869</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS BULLOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOCLASTIC VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugauthorizationnumb>090868</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145033-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7015595</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER PROLAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100822</drugenddate>
        <drugtreatmentduration>149</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN A AND C MULTIVITAMIN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145036-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MYLANLABS-2010S1021879</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGLE CLOSURE GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOROIDAL DETACHMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugauthorizationnumb>076314</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145037-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-238934K09USA</companynumb>
    <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>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERONEAL NERVE PALSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145038-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7029825</companynumb>
    <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>REBIF</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101123</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145039-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7028504</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100825</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145040-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR80440</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN AMLO FIX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021990</drugauthorizationnumb>
        <drugdosagetext>160/5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145041-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA80594</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145042-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP26355</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TASUOMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145043-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US80138</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</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>20101115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONOPIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145044-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010IE06320</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUMERUS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020704</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>400 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100127</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>400 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIPIPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>45 MG, QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145045-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP75059</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TASIGNA</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>800MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100404</drugenddate>
        <drugtreatmentduration>285</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145046-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2010GB05623</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100303</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADCAL-D3</medicinalproduct>
        <drugdosagetext>1 DF, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>500 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-CODAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugdosagetext>7.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1000 MG, BID</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145047-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010FR73131</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>200 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANAFRANIL</medicinalproduct>
        <drugdosagetext>25 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANAFRANIL</medicinalproduct>
        <drugdosagetext>2 DF IN THE EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLOR</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETROL</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145048-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US81248</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>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAPILLOEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101012</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145049-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US47190</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELECTIVE ABORTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SICKLE CELL ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145050-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP36373</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTICONVULSANT DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>50 TABLETS ONCE TOTAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100531</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145051-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010IN39232</companynumb>
    <primarysource>
      <reportercountry>INDIA</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>ALBUMIN URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASUNRA</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THALASSAEMIA BETA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100519</drugenddate>
        <drugtreatmentduration>618</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASUNRA</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>25 MG/KG/DAY</drugdosagetext>
        <drugindication>IRON OVERLOAD</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145052-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010FR80353</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>DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG/5 ML, 1 DF MONTHLY</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145053-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB03440</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>DROOLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN CELL VOLUME DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090717</drugenddate>
        <drugtreatmentduration>585</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080916</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145054-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010TW17668</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081028</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145055-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2007GB02741</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C VIRUS TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</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>20070825</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>350 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080306</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>450 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080612</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080709</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>550 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>600 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>650 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080820</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>700 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>750 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080918</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>800 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145056-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010GR80738</companynumb>
    <primarysource>
      <reportercountry>GREECE</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>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145057-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA74050</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>CARDIAC PACEMAKER INSERTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALISKIREN ALI+</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM ANTAGONISTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACE INHIBITOR NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145058-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA80547</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DEMENTIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101111</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND HCT</medicinalproduct>
        <drugdosagetext>16 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HCT</medicinalproduct>
        <drugdosagetext>12.5 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN CALCIUM</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>500 MG, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DATRIL</medicinalproduct>
        <drugdosagetext>04 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>1 PATCH 75 UG EVERY 3 DAYS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HCL</medicinalproduct>
        <drugdosagetext>2 MG 1-2 TABLET, QID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145059-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20101202290</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRIZOLE</medicinalproduct>
        <drugauthorizationnumb>020657</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CANDIDIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145060-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20101105337</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PALEXIA RETARD</medicinalproduct>
        <drugauthorizationnumb>022304</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101030</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PALEXIA RETARD</medicinalproduct>
        <drugauthorizationnumb>061345</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101030</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145061-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101201162</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG PRESCRIBING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PROCEDURAL PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145062-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101200682</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAKTHROUGH PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENZYME ABNORMALITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <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>1008471P1</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145063-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101200742</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.71</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMEROL</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>100 MG TABLET/300 MG/2 PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
        <drugdosagetext>ONE AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145064-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101104826</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>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENOSYNOVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145065-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-JNJFOC-20101201220</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>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugdosagetext>HALF A PATCH USED</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145066-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-JNJFOC-20101200737</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>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145067-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US80788</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145068-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US72823</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEOPLASM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145069-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US46182</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA FACIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPERATURE INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTAVIA</medicinalproduct>
        <drugdosagetext>0.25 MG, QOD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugdosagetext>UNK,UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>UNK,UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145070-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010AU54247</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>117</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BIFASCICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>1 DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETALOC</medicinalproduct>
        <drugdosagetext>HALF TWICE A DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERSYL PLUS</medicinalproduct>
        <drugdosagetext>1 IN MORNING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIABEX S.R.</medicinalproduct>
        <drugdosagetext>1 TWICE A DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROGRAD C</medicinalproduct>
        <drugdosagetext>1 DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>100 IU/ML, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>70 U,  BEFORE BED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>1 DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>1 IN EVENING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXOLON</medicinalproduct>
        <drugdosagetext>1 EVERY 6 HOURS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOL</medicinalproduct>
        <drugdosagetext>SIX ON 1 DAY REPEAT 48 HOURS LATER</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugdosagetext>2 TWICE A DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>1 IN MORNING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTELIN</medicinalproduct>
        <drugdosagetext>1 DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANADOL OSTEO</medicinalproduct>
        <drugdosagetext>2 THREE TIMES A DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugdosagetext>2 DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>1 DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLOW-K</medicinalproduct>
        <drugdosagetext>2 DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANIDIP</medicinalproduct>
        <drugdosagetext>1 IN MORNING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugdosagetext>1 TWICE A DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145071-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CH80337</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELPHALAN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>CYCLIC APPLICATION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugdosagetext>25 MG, QD, CYCLIC APPLICATION</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090506</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>20 MG, QD, CYCLIC APPLICATION</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090506</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>1.3 MG/M2, CYCLIC APPLICATION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091112</drugenddate>
        <drugtreatmentduration>172</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DISTRANEURIN</medicinalproduct>
        <drugdosagetext>600 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>150 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>500 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugdosagetext>12.5 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAFALGAN</medicinalproduct>
        <drugdosagetext>1000 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYNORM</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMPORTAL</medicinalproduct>
        <drugdosagetext>40 ML, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBETASOL</medicinalproduct>
        <drugdosagetext>2 DF, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145072-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US24529</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>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100414</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>60 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugindication>FATIGUE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>50 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145073-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP78806</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>BREAST CANCER RECURRENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145074-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CH80990</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ORAL SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENDOXAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145075-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US81991</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60.771</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULAR FILTRATION RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART VALVE REPLACEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFRACTORY ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SERUM FERRITIN INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145076-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010IT78443</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>020823</drugauthorizationnumb>
        <drugdosagetext>150 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091210</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORMIX</medicinalproduct>
        <drugdosagetext>200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORVAST</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145077-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR81333</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>34</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT ADHESION ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugdosagetext>4.6 MG/24 HOURS (1 PATCH)</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>9.5 MG/24 HOURS (1 PATCH)</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE</medicinalproduct>
        <drugdosagetext>1 DF, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALSAN</medicinalproduct>
        <drugdosagetext>1 DF AFTER LUNCH</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMALGIN</medicinalproduct>
        <drugdosagetext>1 DF BEFORE LUNCH</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>1 TABLETE IN THE AFTERNOON</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>1 TABLET IN FASTING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROID DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>1 TABLET IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145078-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US80047</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOTOR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LYMPHOPROLIFERATIVE DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145080-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP72851</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>34</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTICONVULSANT DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOTRACHEAL INTUBATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>0.2 G, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101021</drugenddate>
        <drugtreatmentduration>60</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMETEC</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101021</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145081-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010VE80761</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO SPINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1000 MG ONCE A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON OVERLOAD</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>100 MG TWICE A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HAEMOGLOBIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>500 MG THREE TIMES A DAY (5 DAYS)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugdosagetext>500 MG TWICE A DAY (10 DAYS)</drugdosagetext>
        <drugindication>PYREXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATAMEL FORTE</medicinalproduct>
        <drugdosagetext>650 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTEROGERMINA</medicinalproduct>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145082-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US80910</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STEM CELL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1000 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEOPLASM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145083-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR39896</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED ACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE SPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIITH NERVE PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugauthorizationnumb>021014</drugauthorizationnumb>
        <drugdosagetext>300 MG, Q8H</drugdosagetext>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugauthorizationnumb>021014</drugauthorizationnumb>
        <drugdosagetext>300 MG, Q8H</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>50 MG, Q8H</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
        <drugdosagetext>25 MG, 1 TABLET AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>10 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLEPTAL</medicinalproduct>
        <drugdosagetext>300 MG, Q14H</drugdosagetext>
        <drugindication>HEAD INJURY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145084-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CH80213</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC VARICES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL ENDOSCOPIC THERAPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugauthorizationnumb>019201</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100625</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145085-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CH80991</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ORAL SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</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>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugdosagetext>60 MG, EVERY 6 MONTHS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145086-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP68704</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADENOCARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIODONTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>LARGE INTESTINE CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070323</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145087-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010DK81629</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOLFF-PARKINSON-WHITE SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugauthorizationnumb>010187</drugauthorizationnumb>
        <drugdosagetext>7 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101013</drugenddate>
        <drugtreatmentduration>4612</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
        <drugdosagetext>400 MICROGRAM(S)/DOSE</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145088-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010TW82653</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>46</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>750 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>APLASTIC ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>750 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101004</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145089-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US31289</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1000 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SICKLE CELL ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugdosagetext>45 MCG: 21MCG, 2 PUFFS BID</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>1 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYUREA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULFATE</medicinalproduct>
        <drugdosagetext>90 MCG, 2 PUFFS/ 4-6 HOURS</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145090-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08865</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57.142</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTINOMYCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA OF CHRONIC DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIOPSY BONE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HELICOBACTER GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ONYCHOMYCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEPTIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UROSEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>20 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>50 MG A DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>20 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>100 MG A DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>40 DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICRO-K</medicinalproduct>
        <drugdosagetext>10 TWICE A DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COSOPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYLANTA</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
        <drugdosagetext>500 MG, Q4H</drugdosagetext>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
        <drugdosagetext>2 TABLETS EVERY 6 HOURS AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
        <drugdosagetext>2 AT BED TIME</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
        <drugdosagetext>500 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
        <drugdosagetext>250 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugdosagetext>12 MG A DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugdosagetext>10 MG A DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugdosagetext>10,000 UNITS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugdosagetext>20,000 UNITS WEEKLY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugdosagetext>40,000 UNITS WEEKLY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugdosagetext>30 UNITS, TWICE A MONTH</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILVER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTEO BI-FLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILK OF MAGNESIA</medicinalproduct>
        <drugdosagetext>45 CC AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
        <drugdosagetext>15 MG, QHS AS NEEDED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARAFATE</medicinalproduct>
        <drugdosagetext>1 G, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugdosagetext>200 MCG EVERY OTHER WEEK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugdosagetext>1 TABLET (250 MG) DAILY WITH FOOD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEPTRA DS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000120</drugenddate>
        <drugtreatmentduration>59</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENAZOPYRIDINE HCL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOROXIN</medicinalproduct>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010404</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN-D</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010404</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CECLOR CD</medicinalproduct>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUSSIONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXIL ^AYERST LAB^</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145091-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NAPPMUNDI-USA-2010-0046426</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>44.444</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLON CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019516</drugauthorizationnumb>
        <drugdosagetext>1200 MG, Q12H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100310</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA                              /00142201/</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100310</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100309</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019516</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULCOLAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESIPRAMINE HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100311</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100311</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>CANCER PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145093-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007US21920</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145094-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR44689</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG/ 100 ML</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG/100 ML</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145095-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2009JP13580</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHTHOUS STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBCUTANEOUS ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ICL670A ICL+DISTAB</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1375 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELOFIBROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090205</drugenddate>
        <drugtreatmentduration>155</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ICL670A ICL+DISTAB</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1000 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON OVERLOAD</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090312</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELOFIBROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090303</drugenddate>
        <drugtreatmentduration>181</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>10 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090904</drugenddate>
        <drugtreatmentduration>184</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOSYN</medicinalproduct>
        <drugdosagetext>13.5 G, DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090605</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
        <drugdosagetext>1 G, DAILY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090525</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>0.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090303</drugenddate>
        <drugtreatmentduration>181</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>1 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090904</drugenddate>
        <drugtreatmentduration>184</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugdosagetext>35 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090904</drugenddate>
        <drugtreatmentduration>185</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugdosagetext>35 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090904</drugenddate>
        <drugtreatmentduration>184</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090518</drugenddate>
        <drugtreatmentduration>76</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>500 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090518</drugenddate>
        <drugtreatmentduration>75</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHADOL</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090904</drugenddate>
        <drugtreatmentduration>185</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHADOL</medicinalproduct>
        <drugdosagetext>75 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090904</drugenddate>
        <drugtreatmentduration>184</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESFERAL</medicinalproduct>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080821</drugenddate>
        <drugtreatmentduration>246</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS, CONCENTRATED</medicinalproduct>
        <drugdosagetext>2 U, QW</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090304</drugenddate>
        <drugtreatmentduration>182</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS, CONCENTRATED</medicinalproduct>
        <drugdosagetext>2 U, QW</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090904</drugenddate>
        <drugtreatmentduration>184</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145096-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010BR14435</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONCOMITANT DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY BYPASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEPTIC ULCER PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED ALISKIREN ALI+TAB+CF</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>DOUBLE BLIND</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100914</drugenddate>
        <drugtreatmentduration>178</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>DOUBLE BLIND</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100914</drugenddate>
        <drugtreatmentduration>178</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED NO TREATMENT RECEIVED NOMED</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>DOUBLE BLIND</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100914</drugenddate>
        <drugtreatmentduration>178</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALISKIREN</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100122</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145097-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US82950</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145098-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010FR81229</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNTOCINON</medicinalproduct>
        <drugdosagetext>05 IU IN 50 ML OF GLUCOSE 10 %</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>UTERINE ATONY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100816</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOSE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100816</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145099-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US65239</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1500 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100602</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOMEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALSALATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145100-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US15669</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>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145101-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US82924</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145102-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US82980</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>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1000 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON METABOLISM DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
        <drugtreatmentduration>602</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145103-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA82981</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1500 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145104-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR82540</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>STALEVO 100</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021485</drugauthorizationnumb>
        <drugdosagetext>100/25/200 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>300 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145105-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101204</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010TZ18695</companynumb>
    <primarysource>
      <reportercountry>TANZANIA, UNITED REPUBLIC OF</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>17</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COARTEM</medicinalproduct>
        <drugauthorizationnumb>022268</drugauthorizationnumb>
        <drugdosagetext>2 TABLETS BID X 3/7</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090518</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145106-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101202192</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugauthorizationnumb>017821</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WHIPLASH INJURY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145107-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20100703238</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>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAIN KILLERS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145108-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20101005544</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>INCORRECT DRUG ADMINISTRATION DURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145109-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20101202757</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>ALLERGIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAVANIC</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLCYSTEINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145110-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101201416</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.76</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT ADHESION ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugbatchnumb>9LM6671P1</drugbatchnumb>
        <drugauthorizationnumb>021180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NUTRITIONAL SUPPORT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145111-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-JNJFOC-20101201934</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTIEPILEPTICS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTIPSYCHOTIC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145112-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-JNJFOC-20101201856</companynumb>
    <primarysource>
      <reportercountry>GREECE</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>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMINYL</medicinalproduct>
        <drugauthorizationnumb>021169</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145113-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101201803</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>120.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>1008471P1</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAKTHROUGH PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROXICODONE</medicinalproduct>
        <drugdosagetext>30MG/ 1 EVERY 4 TO 6 HOURS AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAKTHROUGH PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145114-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101001244</companynumb>
    <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>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <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>1000868</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145115-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101100896</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>115.21</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTERED AT INAPPROPRIATE SITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145116-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PURDUE-USA-2010-0056452</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021745</drugauthorizationnumb>
        <drugindication>SCIATICA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145117-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-BAXTER-2010BH027334</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</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>PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100311</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLCYSTEINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</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>ACICLOVIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COCILLANA-ETYFIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145120-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201041941NA</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>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASYLOL</medicinalproduct>
        <drugauthorizationnumb>020304</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060717</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145121-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-002225</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>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145122-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-002110</companynumb>
    <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>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081125</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145124-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-002231</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE INJURIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145126-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NAPPMUNDI-USA-2010-0046750</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>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>10 MG, Q12H</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugindication>BREAKTHROUGH PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40 MG, DAILY</drugdosagetext>
        <drugindication>OEDEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>20 MG, DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>0.25 MG, DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugdosagetext>100 MG, DAILY</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145127-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-002081</companynumb>
    <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>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145128-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-002186</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145129-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-002169</companynumb>
    <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>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145130-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-002100</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>GALLBLADDER PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145131-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-002097</companynumb>
    <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>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145154-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20100700329</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCENTRATED MOTRIN INFANTS DROPS</medicinalproduct>
        <drugauthorizationnumb>020603</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCENTRATED MOTRIN INFANTS DROPS</medicinalproduct>
        <drugauthorizationnumb>020603</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCENTRATED TYLENOL INFANT DROPS</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCENTRATED TYLENOL INFANT DROPS</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145155-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20100908331</companynumb>
    <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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOZ FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugbatchnumb>1003190</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOZ FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugbatchnumb>1003190</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROBAXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80/12.5MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIXED CONNECTIVE TISSUE DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145156-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-JNJFOC-20101202775</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019860</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019860</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMPERAN TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145157-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20101000750</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUROTEP MT</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145158-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-JNJFOC-20101100592</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</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>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145159-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA069441</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>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>3F37F</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STENT PLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEBIVOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>060</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145160-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-US-EMD SERONO, INC.-7029244</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>BLOOD TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100409</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145162-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US50305</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGRESSIVE MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>QUALITY OF LIFE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTAVIA</medicinalproduct>
        <drugdosagetext>0.25 MG, QOD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTAVIA</medicinalproduct>
        <drugdosagetext>0.0625 MG, QOS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100720</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAFLUTAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145163-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US52910</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGOMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTAVIA</medicinalproduct>
        <drugbatchnumb>2A2875A</drugbatchnumb>
        <drugdosagetext>0.25 MG, QOD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTAVIA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL SINUS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYQUIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145164-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC.-2010-RO-01561RO</companynumb>
    <primarysource>
      <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>PRODUCT TASTE ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEGESTROL ACETATE</medicinalproduct>
        <drugbatchnumb>956329A</drugbatchnumb>
        <drugauthorizationnumb>075997</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145165-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC.-2010-RO-01563RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugauthorizationnumb>077262</drugauthorizationnumb>
        <drugdosagetext>500 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>625 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>1 G</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145166-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DE-SANOFI-AVENTIS-2010SA040840</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE BEFORE PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020905</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145167-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH010269</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>GANGRENE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145168-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH021773</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FAILURE TO THRIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145172-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DE-SANOFI-AVENTIS-2010SA073487</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020905</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145174-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH021972</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>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145197-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161069</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>CARDIAC STRESS TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CADUET</medicinalproduct>
        <drugauthorizationnumb>021540</drugauthorizationnumb>
        <drugdosagetext>5/10 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CADUET</medicinalproduct>
        <drugauthorizationnumb>021540</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145198-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010164727</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145199-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH022099</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145203-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7029946</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051206</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145204-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-MPIJNJ-2010-05679</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021602</drugauthorizationnumb>
        <drugdosagetext>2.1 MG, CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101021</drugenddate>
        <drugtreatmentduration>111</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLDESAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOPRAL                            /01479301/</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILATREND</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145205-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028635</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOODY PERITONEAL EFFLUENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS VIRAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DRUG USED IN DIABETES</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145206-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20100300539</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFLAMMATORY BOWEL DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPHENAMINE</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145207-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101200526</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugdosagetext>47 INFUSIONS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NARCOTIC ANALGESICS, NOS</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145208-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH029278</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145209-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7030049</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOMICIDAL IDEATION</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>20100801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100925</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145210-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7030041</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TETANUS AND WHOOPING COUGH IMMUNIZATION</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145211-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH029285</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145212-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US80815</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145213-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP75659</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>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugauthorizationnumb>017963</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>060</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145214-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2009CA17403</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROSTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>20 MG, QMO</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SHORT-BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>20 MG, EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145215-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010FR51748</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>SKIN TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG, UNK</drugdosagetext>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145219-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2010165772</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugauthorizationnumb>020385</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100921</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENTAL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULPIRIDE</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145220-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161654</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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugdosagetext>40 MG OR 60 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145221-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161363</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.399</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NOCTURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOVIAZ</medicinalproduct>
        <drugauthorizationnumb>022030</drugauthorizationnumb>
        <drugdosagetext>4 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY INCONTINENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXIL</medicinalproduct>
        <drugdosagetext>FREQUENCY: EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugdosagetext>FREQUENCY: EVERY 6 WEEKS,</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>FREQUENCY: 4 TIMES DAILY,</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugdosagetext>5 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>1200 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>UNIT DOSE: 1000;</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugdosagetext>FREQUENCY: AS NEEDED,</drugdosagetext>
        <drugindication>AGITATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145222-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20101104042</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZALDIAR</medicinalproduct>
        <drugauthorizationnumb>021123</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOOTHACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145229-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US81976</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOBI</medicinalproduct>
        <drugauthorizationnumb>050753</drugauthorizationnumb>
        <drugdosagetext>300 MG, BID</drugdosagetext>
        <drugindication>CYSTIC FIBROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091123</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145230-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US81932</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.957</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOBI</medicinalproduct>
        <drugauthorizationnumb>050753</drugauthorizationnumb>
        <drugdosagetext>300 MG, BID</drugdosagetext>
        <drugindication>CYSTIC FIBROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100211</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145231-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2010GB05403</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>ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <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>20090909</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE</medicinalproduct>
        <drugdosagetext>2 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugdosagetext>10 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090909</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145232-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US81667</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATHETER SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOBI</medicinalproduct>
        <drugauthorizationnumb>050753</drugauthorizationnumb>
        <drugdosagetext>300 MG, BID 28 DAYS ON AND 28 DAYS OFF</drugdosagetext>
        <drugindication>CYSTIC FIBROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOBI</medicinalproduct>
        <drugauthorizationnumb>050753</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101124</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145233-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US81031</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101030</drugenddate>
        <drugtreatmentduration>81</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145234-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-JNJFOC-20101201258</companynumb>
    <primarysource>
      <reportercountry>INDIA</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>BRADYPHRENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>QUALITY OF LIFE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN W/PARACETAMOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>300 MG IN DIVIDED DOSES</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145235-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2010GB05696</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </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>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080123</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145236-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010RU18460</companynumb>
    <primarysource>
      <reportercountry>RUSSIAN FEDERATION</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED ALISKIREN ALI+TAB+CF</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>CODE NOT BROKEN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101128</drugenddate>
        <drugtreatmentduration>186</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>CODE NOT BROKEN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101128</drugenddate>
        <drugtreatmentduration>186</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED NO TREATMENT RECEIVED NOMED</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>CODE NOT BROKEN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101128</drugenddate>
        <drugtreatmentduration>186</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALISKIREN</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMPARATOR ENALAPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145240-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13422BP</companynumb>
    <primarysource>
      <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 150</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021698</drugauthorizationnumb>
        <drugdosagetext>450 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101126</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145241-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010FR77436</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>020234</drugauthorizationnumb>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TRIGEMINAL NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100509</drugenddate>
        <drugtreatmentduration>506</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>020234</drugauthorizationnumb>
        <drugdosagetext>200 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100914</drugenddate>
        <drugtreatmentduration>128</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETAZIDINE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXFORGE</medicinalproduct>
        <drugdosagetext>5/160, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080711</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030623</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145242-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100728</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010US11531</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>ABDOMINAL WALL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STI571/CGP57148B T35717+TAB</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>DOSE BLINDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100722</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145243-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2010GB05468</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>OVERDOSE</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>20000912</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145244-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US81671</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOBI</medicinalproduct>
        <drugauthorizationnumb>050753</drugauthorizationnumb>
        <drugdosagetext>300 MG, BID</drugdosagetext>
        <drugindication>CYSTIC FIBROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENEMA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145246-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20091004371</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCHIZOPHRENIA, DISORGANISED TYPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, DISORGANISED TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugauthorizationnumb>021999</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, DISORGANISED TYPE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145247-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AMGEN-FRANI2010000665</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARBEPOETIN ALFA</medicinalproduct>
        <drugdosagetext>30 MG, Q2WK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090404</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UN ALFA</medicinalproduct>
        <drugdosagetext>1 A?G, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENITEC                            /00574901/</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORDITROPINE SIMPLEXX</medicinalproduct>
        <drugdosagetext>3.3 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICOFENOLATO MOFETIL G</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KAYEXALATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEDROGYL</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugdosagetext>2 DF, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
        <drugdosagetext>250 MG, TID</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145250-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2009289882</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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATTENTION-SEEKING BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPULSIVE SHOPPING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRIME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION OF GRANDEUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXHIBITIONISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSEXUALITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE-COMPULSIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOLOGICAL GAMBLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANS-SEXUALISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CABERGOLINE</medicinalproduct>
        <drugauthorizationnumb>020664</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>2555</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145251-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010115504</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTONIA NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIC-ISCHAEMIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KLEBSIELLA BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL ASPHYXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA KLEBSIELLA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR NEONATAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>50 MG/DAY</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PANIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WYPAX</medicinalproduct>
        <drugdosagetext>1 MG</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PANIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145252-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENZYME-CLOF-1001225</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOLAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021673</drugauthorizationnumb>
        <drugdosagetext>30 MG/M2, QDX5</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080608</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMTUZUMAB OZOGAMICIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>3 MG/M2, QDX3 DAY 1, 4, AND 7</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080604</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMTUZUMAB OZOGAMICIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>3 MG/M2, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080607</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMTUZUMAB OZOGAMICIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>3 MG/M2, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080610</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145274-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US80767</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>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FANAPT</medicinalproduct>
        <drugauthorizationnumb>022192</drugauthorizationnumb>
        <drugdosagetext>6 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145278-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2010US03584</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.098</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTAVIA</medicinalproduct>
        <drugbatchnumb>ZA2875A</drugbatchnumb>
        <drugdosagetext>0.25 MG (0.50 ML), QOD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTAVIA</medicinalproduct>
        <drugdosagetext>0.125 MG, QOD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTAVIA</medicinalproduct>
        <drugbatchnumb>ZA2875A</drugbatchnumb>
        <drugdosagetext>0.25 MG, QOD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100828</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTAVIA</medicinalproduct>
        <drugbatchnumb>ZA2875A</drugbatchnumb>
        <drugdosagetext>0.625 MG, QOD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>2-3 TIMES DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPYRA</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145279-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-BAXTER-2010BH028980</companynumb>
    <primarysource>
      <reportercountry>INDIA</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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>1008055</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145280-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201010005480</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugbatchnumb>09C00510A</drugbatchnumb>
        <drugdosagetext>450 MG, OTHER</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100921</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>890 MG, OTHER</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100921</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>620 MG, OTHER</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100921</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>1 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE</medicinalproduct>
        <drugdosagetext>100 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREGABALIN</medicinalproduct>
        <drugdosagetext>150 MG, 3/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN</medicinalproduct>
        <drugdosagetext>0.4 MG, EACH EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
        <drugdosagetext>5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOTRIMAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE AND ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>1000 UG, UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100826</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145281-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-ELI_LILLY_AND_COMPANY-PL201008003750</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NECITUMUMAB (11F8) (LY3012211)</medicinalproduct>
        <drugdosagetext>800 MG, OTHER</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HCL</medicinalproduct>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugdosagetext>1987 MG, OTHER</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>119 MG, OTHER</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMAL</medicinalproduct>
        <drugdosagetext>100 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugdosagetext>2 D/F, 4/D</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOSPIREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HELICID</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIOCODIN                          /01295801/</medicinalproduct>
        <drugdosagetext>1 D/F, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145282-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHIRE-ALL1-2010-06321</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.562</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR GRAFT COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSRENOL</medicinalproduct>
        <drugbatchnumb>A5065A</drugbatchnumb>
        <drugauthorizationnumb>021468</drugauthorizationnumb>
        <drugdosagetext>1000 MG, AFTER EACH MEAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNSPECIFIED SLEEPING PILL</medicinalproduct>
        <drugdosagetext>UNK UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145283-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-319175</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>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>1.8 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTARA (MICRONIZED)</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145284-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</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>GASTRITIS ATROPHIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN-LOSING GASTROENTEROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORDITROPIN NORDIFLEX CHU</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>LEUPLIN</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>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>RENIVACE</medicinalproduct>
        <drugdosagetext>2.2 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>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>DIGOSIN</medicinalproduct>
        <drugdosagetext>0.12 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMBOCOR</medicinalproduct>
        <drugdosagetext>120 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145285-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100601</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-NOVOPROD-309143</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTRAPID</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULATARD HM</medicinalproduct>
        <drugauthorizationnumb>019959</drugauthorizationnumb>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GOPTEN</medicinalproduct>
        <drugdosagetext>2 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRONOL</medicinalproduct>
        <drugdosagetext>2 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>6 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIOFOR</medicinalproduct>
        <drugdosagetext>2550 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIOSOTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BESTPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MILURIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORIS                             /01326101/</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MILGAMMA                           /00089801/</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRANXENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETONAL                            /00321701/</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENTOXIFYLLINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100416</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLAVULANATE POTASSIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100416</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145286-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-NOVOPROD-319380</companynumb>
    <primarysource>
      <reportercountry>CHINA</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>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPITUITARISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLIN R</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>019991</drugauthorizationnumb>
        <drugdosagetext>INTERMITTENTLY</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XIAOKE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145287-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-NOVOPROD-289492</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>30</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENINGEAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORDITROPIN</medicinalproduct>
        <drugauthorizationnumb>019721</drugauthorizationnumb>
        <drugdosagetext>1.4 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090112</drugenddate>
        <drugtreatmentduration>2649</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISON                      /00028601/</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINIRIN                            /00361901/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASTONIN H</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145288-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>LB-NOVOPROD-317174</companynumb>
    <primarysource>
      <reportercountry>LEBANON</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>144</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>0.6 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugindication>OBESITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145289-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-NOVOPROD-319439</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugbatchnumb>UK</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugauthorizationnumb>020986</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145290-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NOVOPROD-318289</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>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID CHU FLEXPEN</medicinalproduct>
        <drugauthorizationnumb>020986</drugauthorizationnumb>
        <drugdosagetext>18 U, QD</drugdosagetext>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100606</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID CHU FLEXPEN</medicinalproduct>
        <drugbatchnumb>NA</drugbatchnumb>
        <drugauthorizationnumb>020986</drugauthorizationnumb>
        <drugdosagetext>2400 U, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100606</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID CHU FLEXPEN</medicinalproduct>
        <drugbatchnumb>N/A</drugbatchnumb>
        <drugauthorizationnumb>020986</drugauthorizationnumb>
        <drugdosagetext>900 U, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID CHU FLEXPEN</medicinalproduct>
        <drugbatchnumb>N/A</drugbatchnumb>
        <drugauthorizationnumb>020986</drugauthorizationnumb>
        <drugdosagetext>2-2-2 U QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>20 U, QD</drugdosagetext>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100606</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>900 U, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100606</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>6-0-0 U QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145291-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NOVOPROD-319105</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugbatchnumb>N/A</drugbatchnumb>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>0.3 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101023</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugbatchnumb>N/A</drugbatchnumb>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>0.6 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITOROL</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIGMART</medicinalproduct>
        <drugdosagetext>15 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugdosagetext>15 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIYARISAN BM</medicinalproduct>
        <drugdosagetext>3 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRAMALIL</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMICRON</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDE                          /00571901/</medicinalproduct>
        <drugdosagetext>12 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIBENOL</medicinalproduct>
        <drugdosagetext>150 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145301-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH029254</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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100922</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145302-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-PFIZER INC-2010162229</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145303-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010163751</companynumb>
    <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>ADVIL</medicinalproduct>
        <drugauthorizationnumb>020402</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145304-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010160944</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101129</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>YODEL</medicinalproduct>
        <drugdosagetext>80 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100406</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugdosagetext>0.5 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100406</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>1 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>5 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>5 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100406</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100406</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SITAGLIPTIN PHOSPHATE</medicinalproduct>
        <drugdosagetext>50 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100406</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145307-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH021164</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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145308-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028611</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>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145309-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028938</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN STEM STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101123</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145310-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028956</companynumb>
    <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>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101129</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145311-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH029024</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145312-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-AVENTIS-2010SA071540</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KARDEGIC</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100312</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROFENID</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FRACTURED SACRUM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100311</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROFENID</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100311</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100312</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145322-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-US-EMD SERONO, INC.-7029915</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugbatchnumb>Y15A7820</drugbatchnumb>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugbatchnumb>Y15A7820</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145323-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-US-EMD SERONO, INC.-7029917</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugbatchnumb>Y16A2618</drugbatchnumb>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101126</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALMAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMETICONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSCOPAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACHEFLAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145324-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-US-EMD SERONO, INC.-7029918</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugbatchnumb>Y16A2618</drugbatchnumb>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100409</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145325-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-US-EMD SERONO, INC.-7029904</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYSIPELAS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100421</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145326-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-US-EMD SERONO, INC.-7025558</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIANE</medicinalproduct>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145327-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-US-EMD SERONO, INC.-7029625</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISCITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugbatchnumb>Y16A5614</drugbatchnumb>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugbatchnumb>Y16A5614</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145328-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-US-EMD SERONO, INC.-230151J10CAN</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>CENTRAL NERVOUS SYSTEM LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145329-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HU-ABBOTT-10P-076-0647062-00</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>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101018</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145330-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-10P-020-0689307-00</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>870129A01</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>870129A01</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145331-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-BAXTER-2010BH025121</companynumb>
    <primarysource>
      <reportercountry>INDIA</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>PERITONEAL TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>1008052</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145332-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010163162</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</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>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEELCHAIR USER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145333-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010163508</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATIC CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145334-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010095834</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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>CHANTIX STARTING PACK</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145335-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010133577</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>200 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101014</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE</medicinalproduct>
        <drugdosagetext>30 MG, EVERY SIX HOURS</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145336-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010091922</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>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <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>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ROUTINE HEALTH MAINTENANCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100320</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100329</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SLEEP DISORDER THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100329</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100110</drugenddate>
        <drugtreatmentduration>1097</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENAZOPYRIDINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091222</drugenddate>
        <drugtreatmentduration>1078</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091217</drugenddate>
        <drugtreatmentduration>1073</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091230</drugenddate>
        <drugtreatmentduration>1049</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070618</drugenddate>
        <drugtreatmentduration>123</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070225</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070618</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACULAR ^ALLERGAN^</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GATIFLOXACIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070523</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145337-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010015616</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF PRESSURE</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>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145338-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010163198</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.39</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHROSCOPIC SURGERY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugindication>SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugdosagetext>7.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugdosagetext>30 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugdosagetext>150 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145339-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-NOVOPROD-319436</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>93</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugauthorizationnumb>021536</drugauthorizationnumb>
        <drugdosagetext>18 U, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100820</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugbatchnumb>YP51032</drugbatchnumb>
        <drugauthorizationnumb>021536</drugauthorizationnumb>
        <drugdosagetext>32 U, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
        <drugdosagetext>15+1500</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GALVUS</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145341-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-NOVOPROD-319447</companynumb>
    <primarysource>
      <reportercountry>TURKEY</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>NOVOSEVEN</medicinalproduct>
        <drugindication>HAEMOPHILIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145342-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-NOVOPROD-319437</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVONORM</medicinalproduct>
        <drugbatchnumb>UK</drugbatchnumb>
        <drugauthorizationnumb>020741</drugauthorizationnumb>
        <drugdosagetext>2 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEMANTINE HCL</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>1 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVISCAN                          /00261401/</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COVERSYL                           /00790702/</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145343-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-NOVOPROD-307423</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>105.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREATH ODOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>0.6 MG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100330</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugbatchnumb>N/A</drugbatchnumb>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>1.2 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100418</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>0.6 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100423</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>1.2 MG, QD</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100506</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145344-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NOVOPROD-319375</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID CHU PENFILL</medicinalproduct>
        <drugbatchnumb>NA</drugbatchnumb>
        <drugauthorizationnumb>020986</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID 30 MIX CHU PENFILL</medicinalproduct>
        <drugbatchnumb>NA</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145345-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-NOVOPROD-315993</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>150</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>1.8 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
        <drugtreatmentduration>142</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMID                          /00032601/</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145347-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100413</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA020469</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>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STENT PLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145348-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TH-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-CS-01038RT</companynumb>
    <primarysource>
      <qualification>3</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>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145349-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13629BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADRENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <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>20100804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145350-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-SW-00367DB</companynumb>
    <primarysource>
      <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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>FORMULATION; INHAL.</drugdosagetext>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVIAL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BERODUAL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOLYSIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145351-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2008-BP-17449BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENIGN PROSTATIC HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND SECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>810212A,8C2204</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL/THYROXINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSTATE MED</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145352-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC.-2010-RO-01587RO</companynumb>
    <primarysource>
      <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>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugbatchnumb>061091A</drugbatchnumb>
        <drugauthorizationnumb>076504</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugbatchnumb>061091A</drugbatchnumb>
        <drugauthorizationnumb>076504</drugauthorizationnumb>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugindication>SINUSITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145353-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13779BP</companynumb>
    <primarysource>
      <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>HAEMORRHAGE INTRACRANIAL</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>7145354-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-US-EMD SERONO, INC.-7029756</companynumb>
    <primarysource>
      <reportercountry>CHINA</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>ASCITES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GONAL-F</medicinalproduct>
        <drugauthorizationnumb>020378</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>IN VITRO FERTILISATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101109</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145355-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7030126</companynumb>
    <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>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090819</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145356-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7030165</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PATCH</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugindication>BLADDER DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145361-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101200612</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>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIALDA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145362-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20101200799</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL SQUAMOUS CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADCAL-D3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-CODAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145363-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-US-WYE-H17415610</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugbatchnumb>E42038</drugbatchnumb>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HANGOVER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugbatchnumb>E42038</drugbatchnumb>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>4 TABLETS X1</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALAISE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100820</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugbatchnumb>E42038</drugbatchnumb>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100906</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145364-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-567104</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugdosagetext>RECEIVED ONLY ONE DOSE; FORM: PILL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
        <drugdosagetext>TAKEN INFREQUENTLY</drugdosagetext>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugdosagetext>TAKEN INFREQUENTLY</drugdosagetext>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145365-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-687506</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>ABORTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRA-UTERINE DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMIFLU</medicinalproduct>
        <drugauthorizationnumb>021087</drugauthorizationnumb>
        <drugdosagetext>DOSE FORM: ORAL FORMULATION (NOT OTHERWISE SPECIFIED)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091120</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145366-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-692877</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>LAST DOSE PRIOR TO SAE: 10 MARCH 2010.TEMPORARILY INTERUPTED.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100331</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100421</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>FREQUENCY: W1,W2,W3, TEMPORARILY INTERUPPTED</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100324</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100421</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>DOSE: 6 AUC, FREQUENCY: W1, TEMPORARILY INTERRUPTED</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100331</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100421</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145367-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-ROCHE-706549</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENGUE FEVER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugdosagetext>FREQUENCY: DAILY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>FREQUENCY: QD.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>FREQUENCY: QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145368-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-708005</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BENIGN NEOPLASM OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN NODULE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugdosagetext>FORM: INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091230</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091230</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugdosagetext>FREQUENCY: AMPULE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SCULPTRA</medicinalproduct>
        <drugdosagetext>ROUTE:DEEP DERMIS, DOSE: HALF OF A FLASK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080918</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugdosagetext>FREQUENCY: 1 TABLET PER DAY, DOSE: 20 MG</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>DOSE: 175 MCG, FREQ: 1 TABLET/DAY</drugdosagetext>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>DOSE: 20 MG, FREQ: 1 TABLET/DAY,ADDITIONAL  INDICATION: STRESS RELIEVER</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBRA</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145369-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-718194</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>NOTE: IT IS ONE ADMINISTERING WEEKLY HOLIDAY MEDICINE FOR TWO WEEKS.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100629</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELPLAT</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIDOXAL CALCIUM PHOSPHATE</medicinalproduct>
        <drugdosagetext>REPORTED AS ADEROXAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLOW-K</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMITT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145370-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-719236</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHAPPED LIPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON ADENOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145371-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-719278</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE NODULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOPHLEBITIS SUPERFICIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021858</drugauthorizationnumb>
        <drugdosagetext>FORM: INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145372-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-719932</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>ABDOMINAL ADHESIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>FREQUENCY:DAY 1 AND 15 OF 3 WEEK CYCLE. ACTUAL DOSE GIVEN:1500MG. LAST DOSE PRIOR TO SAE: 6 AUG 2010</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>FREQUENCY: DAY 1 OF 3 WEEKS CYCLE. ACTUAL DOSE RECEIVED:211MG. LAST DOSE PRIOR TO SAE: 26 JUL 2010</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugdosagetext>SCHEDULE REPORTED AS 20G- 0 -20G</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UNEVALUABLE EVENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100806</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERGENTAN</medicinalproduct>
        <drugdosagetext>SCHEDULE REPORTED AS 2X1</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100806</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100803</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MCP</medicinalproduct>
        <drugdosagetext>DOSE REPORTED AS 3X5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100728</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
        <drugdosagetext>ONCE  A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENABETA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEP</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145373-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ALEXION-A201000958</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE RELATED SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLUGGISHNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIRIS</medicinalproduct>
        <drugdosagetext>600 MG, QW</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAROXYSMAL NOCTURNAL HAEMOGLOBINURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100828</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIRIS</medicinalproduct>
        <drugdosagetext>900 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMAXIN                           /00788801/</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MENACTRA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>IMMUNISATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100807</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>2 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145374-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-724032</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADJUSTMENT DISORDER WITH MIXED ANXIETY AND DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEILITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEFAECATION URGENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>20 MG DAILY X 7 DAYS</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19910124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19910222</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990414</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>20 MG 4 X PER WEEK AND 40 MG 3 X PER WEEK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990731</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>INCREASED DOSE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>DOSE OF 8-10 MG/KG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNALAR OINTMENT</medicinalproduct>
        <drugdosagetext>TID FOR 4 DAYS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLAQUIN FORTE CREAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIPHASIL-28</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugdosagetext>COMPOUND</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PCE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145375-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-731701</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugbatchnumb>H6136H01</drugbatchnumb>
        <drugauthorizationnumb>021858</drugauthorizationnumb>
        <drugdosagetext>FIRST INJECTION, INDICATION: BAD BONE SCAN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugbatchnumb>H6136H01</drugbatchnumb>
        <drugauthorizationnumb>021858</drugauthorizationnumb>
        <drugdosagetext>2ND INJECTION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100826</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugdosagetext>INDICATION: BAD BONE SCAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE DENSITY DECREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugdosagetext>2 TABLETS IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SOMNOLENCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugdosagetext>DOSE: 20 IN AM AND 10 AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ADRENAL INSUFFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugdosagetext>IN THE EVENING (PM)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>VITAMIN B12 DEFICIENCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145376-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>UA-ROCHE-732517</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>111.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIOSTITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>SOLUTION FOR INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100528</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMSIROLIMUS</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100528</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145377-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-734187</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>FASCIITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugbatchnumb>H6128H01</drugbatchnumb>
        <drugauthorizationnumb>021858</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULAR</medicinalproduct>
        <drugdosagetext>DOSE: 8.5 DAILY, DRUG REPORTED AS SULARS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>DOSE: 0.15 DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145378-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-738134</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>1.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EXTERNAL AUDITORY CANAL ATRESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRIS COLOBOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICROPHTHALMOS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICROTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE LABOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100506</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRIN</medicinalproduct>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROPOIETIN ALFA</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100506</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100506</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMID</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100506</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUVASTATIN</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100506</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100506</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EISEN(II)-GLUCONAT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145379-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-ROCHE-738710</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>FORM: INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>FREQUENCY AS REPORTED: TWICE PER DAY FOR DAYS 1-14.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>FORM: INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANADOL</medicinalproduct>
        <drugdosagetext>FREQUNCY: WHEN NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMAL</medicinalproduct>
        <drugdosagetext>FREQUENCY: WHEN NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON HCL</medicinalproduct>
        <drugdosagetext>FREQUENCY: WHEN NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN</medicinalproduct>
        <drugdosagetext>FREQUENCY: WHEN NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPINOX</medicinalproduct>
        <drugdosagetext>FREQUENCY: WHEN NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
        <drugdosagetext>FREQUENCY: WHEN NEEDED</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145389-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-AMGEN-US305832</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CUTANEOUS VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080903</drugenddate>
        <drugtreatmentduration>1746</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145390-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-AMGEN-KDL412094</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>6 MG, QCYCLE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090213</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145391-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AMGEN-QUU435610</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>APHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
        <drugtreatmentduration>197</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLATELETS, CONCENTRATED</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOL                          /00661201/</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>47.5 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145392-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU416377</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACUTE LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW RETICULIN FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC LYMPHOCYTIC LEUKAEMIA TRANSFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME TRANSFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFRACTORY ANAEMIA WITH AN EXCESS OF BLASTS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugbatchnumb>1016578</drugbatchnumb>
        <drugdosagetext>750 A?G, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOCYTOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100602</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugbatchnumb>1016579</drugbatchnumb>
        <drugdosagetext>750 A?G, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100525</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugbatchnumb>10139001</drugbatchnumb>
        <drugdosagetext>750 A?G, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100525</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugbatchnumb>1013896</drugbatchnumb>
        <drugdosagetext>750 A?G, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100525</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugbatchnumb>1013900</drugbatchnumb>
        <drugdosagetext>750 A?G, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100525</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugbatchnumb>1017279</drugbatchnumb>
        <drugdosagetext>750 A?G, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100525</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugbatchnumb>1017790</drugbatchnumb>
        <drugdosagetext>750 A?G, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100525</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugbatchnumb>1013896</drugbatchnumb>
        <drugdosagetext>750 A?G, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100525</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROID NOS</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENALIDOMIDE</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
        <drugtreatmentduration>57</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100521</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100525</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145393-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ROCHE-742007</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUROENDOCRINE CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugbatchnumb>B1001, B1002</drugbatchnumb>
        <drugdosagetext>DOSAGE FORM: INFUSION. 20 JUL 2010 REPORTED AS WEEK 260.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugbatchnumb>B0001,B1002</drugbatchnumb>
        <drugdosagetext>23 JUNE 2010; LAST INFUSION PRIOR TO SAE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLINA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRAPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145394-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20101003047</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYPTOCOCCOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugdosagetext>INITIAL DOSE OF 3 TO 5 MG/KG AT WEEK 0, WEEK 2, WEEK 6 AND THEN EVERY SIX TO EIGHT WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SARCOIDOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145395-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-SANOFI-AVENTIS-2010SA065115</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>82</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTAQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>022425</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101003</drugenddate>
        <drugtreatmentduration>140</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISIHEXAL</medicinalproduct>
        <drugdosagetext>DOSAGE: 1/2-0-1/2</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL</medicinalproduct>
        <drugdosagetext>DOSAGE: 1/2-0-1/2</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>DOSAGE: 0-0-1/2</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>DOSAGE: 1-0-0 HUB</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORMOTEROL FUMARATE</medicinalproduct>
        <drugdosagetext>DOSAGE: 1-0-1 HUB</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145397-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010FR81588</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARROW HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALSARTAN  AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugdosagetext>ONE TABLET DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101030</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>ONE TABLET DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101030</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145398-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010US08469</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL STROMAL TUMOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPICE CARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMN107 AMN+CAP</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC-D 12 HOUR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145399-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2010GB04602</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>GASTROINTESTINAL TUBE INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</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>19940922</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145400-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2010GB05306</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OCULOGYRIC CRISIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>625 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145401-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2010GB04979</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</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>20090629</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145402-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-743782</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>167</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>050723</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BASILIXIMAB</medicinalproduct>
        <drugdosagetext>LAST DOSE PRIOR TO SAE: APPROXIMATELY 07 NOVEMBER 2010</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145403-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010162985</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>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOVIAZ</medicinalproduct>
        <drugauthorizationnumb>022030</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLLAKIURIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145404-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161660</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145405-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010162146</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>VENLAFAXINE HCL</medicinalproduct>
        <drugauthorizationnumb>020151</drugauthorizationnumb>
        <drugdosagetext>UNK G/L, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145406-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010163629</companynumb>
    <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>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145407-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010148795</companynumb>
    <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>25 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPOTEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145408-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010145176</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>020882</drugauthorizationnumb>
        <drugdosagetext>300 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145409-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010163175</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>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugdosagetext>600 MG, UNK</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145410-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161299</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>46.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAIR GROWTH ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAIR TEXTURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>50 MG, ALTERNATE DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145411-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010162163</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>VENLAFAXINE HCL</medicinalproduct>
        <drugauthorizationnumb>020151</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145412-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160786</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST HERPETIC NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 4X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE</medicinalproduct>
        <drugdosagetext>200 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugdosagetext>3 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145413-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010164129</companynumb>
    <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>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145414-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010163189</companynumb>
    <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>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145415-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101204</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010164053</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.052</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>100 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>1 MG, 4X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugdosagetext>300 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISDEXAMFETAMINE DIMESYLATE</medicinalproduct>
        <drugdosagetext>70 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>500 MG, 2X/DAY</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145416-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-ROCHE-743827</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONGESTIVE CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>FREQUENCY: D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145417-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-745309</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIC SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>CYCLE 1</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>CYCLE 1</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101004</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145418-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-SANOFI-AVENTIS-2010SA070073</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS TOXIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTAQ</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022425</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTAQ</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022425</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMCONCOR /SPA/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEGURIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMAZINA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINTROM</medicinalproduct>
        <drugdosagetext>DOSE:0.5 UNIT(S)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANGOREX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101108</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145419-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-JNJFOC-20101106048</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>CYCLE 1</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145420-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-AVENTIS-2010SA070544</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME SHORTENED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTAQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>022425</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101026</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERSYL /FRA/</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARDEGIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLECAINIDE ACETATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145421-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2009JP48659</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DIASTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROGENIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>80 MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081028</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>120 MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081125</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>160 MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugdosagetext>12 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080930</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIART</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIART</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIART</medicinalproduct>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDENALIN</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAINTATE</medicinalproduct>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NATRIX</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090812</drugenddate>
        <drugtreatmentduration>190</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT CC</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090401</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANALDINE</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER D</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090303</drugenddate>
        <drugtreatmentduration>210</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENECID</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLELOCK</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090501</drugenddate>
        <drugtreatmentduration>59</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090304</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLORIC</medicinalproduct>
        <drugdosagetext>0.5 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBESSER</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRANDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>2 DF IN THE MORNING AND AT 2 DF IN THE NOON DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATELEC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100303</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145422-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2010GB05106</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>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DROOLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>200MG MANE AND 225MG NOCTE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100819</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>200MG MANE AND 250MG NOCTE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>175 MG MORNING + 150 MG NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENSURE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugdosagetext>15 ML</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FYBOGEL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUDOCREM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ANAL ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALAMINE LOTION</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>ALTERNATE DAYS</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>RECTAL ULCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145423-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100114</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010AU81125</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145424-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-SANOFI-AVENTIS-2010SA071683</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNDERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTAQ</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022425</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145425-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DROOLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METHAEMOGLOBINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSTRUCTIVE AIRWAYS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HURRICAINE</medicinalproduct>
        <drugdosagetext>GEL</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145426-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-TEVA-256262ISR</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>074656</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100803</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>074656</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100803</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON HYDROCHLORIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APREPITANT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100427</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100630</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145427-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-TEVA-256871ISR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugauthorizationnumb>020622</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145428-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ROCHE-745466</companynumb>
    <primarysource>
      <reportercountry>CHINA</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>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2A</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145429-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-745730</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugbatchnumb>B0015B019</drugbatchnumb>
        <drugdosagetext>FORM: INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145430-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20101106741</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>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IXPRIM</medicinalproduct>
        <drugauthorizationnumb>021123</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>PREVISCAN (FLUINDIONE)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145431-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101202586</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHOKING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DROOLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugauthorizationnumb>021999</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145432-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-JNJFOC-20101202270</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145433-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20100707441</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>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENISCUS LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHARYNGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLONOSCOPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIVERTICULITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIVERTICULITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145434-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-745828</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>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>LAST DOSE PRIOR TO EVENT: 16 NOVEMBER 2010</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>LAST DOSE PRIOR TO EVENT: 16 NOVEMBER 2010</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>LAST DOSE PRIOR TO EVENT: 16 NOVEMBER 2010</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145450-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-ROCHE-745991</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145451-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010165148</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>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145452-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010162546</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>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145453-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010006595</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>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCREAMING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</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>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, 1X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, 1X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>1.25 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE LEVEL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND HYDROCODONE BITARTRATE</medicinalproduct>
        <drugdosagetext>10/325 MG, AS NEEDED OR TAKING 1 TO 4 TABLETS IN A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145454-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160896</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>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>25 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>COLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZEGERID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145455-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161421</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85.714</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>084427</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>25 UG, UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>50 UG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145456-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160936</companynumb>
    <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>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>400 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>BURNING SENSATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145457-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010165484</companynumb>
    <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>MALAISE</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>20101117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>1 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145458-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161489</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ENURESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>0.5 MG, 4X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>500 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145459-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010130339</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.306</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</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>20100621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVSIN</medicinalproduct>
        <drugdosagetext>0.125 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FLATULENCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145460-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160173</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55.791</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY HEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAINFUL RESPIRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>VITAMIN D DEFICIENCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugindication>CEREBRAL AUTOSOMAL DOMINANT ARTERIOPATHY WITH SUBCORTICAL INFARCTS AND LEUKOENCEPHALOPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugindication>CEREBRAL AUTOSOMAL DOMINANT ARTERIOPATHY WITH SUBCORTICAL INFARCTS AND LEUKOENCEPHALOPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145461-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010166215</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>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145462-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010152168</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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145463-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010165160</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>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145464-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010122202</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>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</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>20070421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145465-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101127</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010158634</companynumb>
    <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>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145466-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161306</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145467-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010165158</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>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145468-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-746003</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMAL NEWBORN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OSELTAMIVIR</medicinalproduct>
        <drugauthorizationnumb>021087</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>INFLUENZA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101122</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145469-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010165294</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>MALAISE</reactionmeddrapt>
      </reaction>
      <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>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>1 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145470-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010166217</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>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</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>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145471-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010166210</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>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145472-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ROCHE-746028</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACTEMRA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080415</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG TOXICITY PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080905</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080905</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>DRUG NAME: HIDROCHLOROTIAZIDE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100905</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145473-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-10P-167-0617454-00</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>COMPLICATION OF DELIVERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091218</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145474-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ABBOTT-10P-008-0683438-00</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>LYMPHOCYTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071121</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145475-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060306</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-746165</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE LEAKAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145476-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>LK-ROCHE-746181</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 FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE</medicinalproduct>
        <drugauthorizationnumb>050585</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APIXABAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080911</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080911</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080717</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145477-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-746226</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOGEN RESISTANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OSELTAMIVIR</medicinalproduct>
        <drugauthorizationnumb>021087</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>H1N1 INFLUENZA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OSELTAMIVIR</medicinalproduct>
        <drugauthorizationnumb>021087</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugdosagetext>DOSE INREASED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMATINIB MESYLATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145478-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-ROCHE-745329</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>DOSE:1095, FREQUENCY:3 WEEK, LAST DOSE PRIOR TO SAE:12 NOV 2010</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091112</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145480-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-745550</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145481-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2010R1-39932</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE + ZIDOVUDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANTIRETROVIRAL THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145482-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2010R1-39905</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>OVERDOSE</reactionmeddrapt>
      </reaction>
      <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>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>070469</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPHENIDATE</medicinalproduct>
        <drugdosagetext>1500 MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHANOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145483-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-RANBAXY-2010RR-39808</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugauthorizationnumb>076990</drugauthorizationnumb>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JATROSOM</medicinalproduct>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYRAMINE</medicinalproduct>
        <drugindication>SUICIDE ATTEMPT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145484-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-SANOFI-AVENTIS-2010SA072238</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTAQ</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022425</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLECAINIDE ACETATE</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145485-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-ROCHE-745974</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>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRCERA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECORMON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145486-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-01272BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.25</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMPULSIVE SHOPPING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE-COMPULSIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOLOGICAL GAMBLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145487-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-01858BP</companynumb>
    <primarysource>
      <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>SPIRIVA</medicinalproduct>
        <drugbatchnumb>906980A,8C1203,906849A,UNKNOWN,9051</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>906980A,8C1203,906849A,UNKNOWN,9051</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
        <drugdosagetext>0.5 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>2.5 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
        <drugdosagetext>25 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>50 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
        <drugdosagetext>2 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIPAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTIFICIAL TEARS POLYVINYL ALCOHOL</medicinalproduct>
        <drugindication>DRY EYE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugindication>AGITATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUBRICATING OPH OINT</medicinalproduct>
        <drugindication>DRY EYE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOISTURIZING LOTION</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DRY SKIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL DISCOMFORT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM HYALURONATE</medicinalproduct>
        <drugadministrationroute>014</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145488-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13304BP</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>150 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145489-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-01275BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>106.59</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPULSIVE SHOPPING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE-COMPULSIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOLOGICAL GAMBLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145490-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20101101841</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DISPENSING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugbatchnumb>35528;35538A</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GENERALISED NON-CONVULSIVE EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugbatchnumb>35528;35538A</drugbatchnumb>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugbatchnumb>35528;35538A</drugbatchnumb>
        <drugdosagetext>1 X 50 MG MORNING AND 2 X 100 MG NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugbatchnumb>35528;35538A</drugbatchnumb>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INFLUENZA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOFRAMYCIN EAR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHOLESTEATOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145491-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20091204992</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugdosagetext>CYCLE 1</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER RECURRENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugdosagetext>CYCLE 2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugdosagetext>CYCLE 3</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugdosagetext>CYCLE 4</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAI KENCHU TO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SHAKUYAKU-K ANZO-TO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEQUALINIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHARYNGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NON-PYRINE COLD PREPARATION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRAN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>NEUTROPENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRAN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRAN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRAN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>WHITE BLOOD CELL COUNT DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRAN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRAN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCENTRATED HUMAN RED BLOOD CELLS</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145492-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-01269BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>101.15</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BIPOLAR I DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPULSIVE SHOPPING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE-COMPULSIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOLOGICAL GAMBLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145493-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROXANE LABORATORIES, INC.-2010-DE-04246GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTENSOR PLANTAR RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>076934</drugauthorizationnumb>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
        <drugdosagetext>150 MG</drugdosagetext>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145494-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-745987</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>LARGE INTESTINE CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>DRUG REPORTED AS: XELODA 300 DOSAGE IS UNCERTAIN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LARGE INTESTINE CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELPLAT</medicinalproduct>
        <drugdosagetext>DOSAGE IS UNCERTAIN</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>DOSAGE IS UNCERTAIN</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100914</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145495-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070410</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-746054</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145496-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-746114</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145497-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA072737</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>NON-CARDIOGENIC PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTAQ</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022425</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145498-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EC-ROCHE-746146</companynumb>
    <primarysource>
      <reportercountry>ECUADOR</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugdosagetext>FREQUENCY:EVERY MONTH</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100313</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145499-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-746234</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GANCICLOVIR</medicinalproduct>
        <drugauthorizationnumb>020460</drugauthorizationnumb>
        <drugdosagetext>DRUG STOPPED</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GANCICLOVIR</medicinalproduct>
        <drugauthorizationnumb>020460</drugauthorizationnumb>
        <drugdosagetext>ROUTE INTRAVETREAL, DOSE: UP TO 3 MG IN 0.1ML</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR SODIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145500-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-746253</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugauthorizationnumb>050585</drugauthorizationnumb>
        <drugdosagetext>IN THE MORNING AND IN THE EVENING</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145501-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-ROCHE-746389</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUSTULAR PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMIFLU</medicinalproduct>
        <drugauthorizationnumb>021087</drugauthorizationnumb>
        <drugdosagetext>FREQUENCY AS REPORTED: X2</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>H1N1 INFLUENZA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTIVELLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>FREQUENCY: X1/6 DAYS PER WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COELIAC DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145502-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-746275</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMIFLU</medicinalproduct>
        <drugauthorizationnumb>021087</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145504-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-SANOFI-AVENTIS-2010SA073711</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>95</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTAQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>022425</drugauthorizationnumb>
        <drugdosagetext>2X1 FILM-COATED TABLET AT 400 MG DAILY PER OS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101011</drugenddate>
        <drugtreatmentduration>77</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145505-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-746294</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENINGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145518-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHIRE-ALL1-2010-06356</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>FOSRENOL</medicinalproduct>
        <drugauthorizationnumb>021468</drugauthorizationnumb>
        <drugdosagetext>500 MG, 2X/DAY:BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSRENOL</medicinalproduct>
        <drugauthorizationnumb>021468</drugauthorizationnumb>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145519-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20101101493</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMATOFORM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>5 MG/KG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145536-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010139848</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>GENITAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIPIDS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101023</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145537-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010152300</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>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>80 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELCHOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145538-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010149300</companynumb>
    <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>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145539-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA067164</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>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugbatchnumb>21079</drugbatchnumb>
        <drugauthorizationnumb>020164</drugauthorizationnumb>
        <drugdosagetext>AT 6AM AND 6 PM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugbatchnumb>21079</drugbatchnumb>
        <drugauthorizationnumb>020164</drugauthorizationnumb>
        <drugdosagetext>AT 6AM AND 6 PM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SURGERY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugbatchnumb>21079</drugbatchnumb>
        <drugauthorizationnumb>020164</drugauthorizationnumb>
        <drugdosagetext>AT 6 AM AND 6 PM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugbatchnumb>21079</drugbatchnumb>
        <drugauthorizationnumb>020164</drugauthorizationnumb>
        <drugdosagetext>AT 6 AM AND 6 PM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145540-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VN-SANOFI-AVENTIS-2010SA073387</companynumb>
    <primarysource>
      <reportercountry>VIET NAM</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020164</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101130</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145543-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-746356</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOBIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugauthorizationnumb>017533</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugauthorizationnumb>017533</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>DRUG REPORTED AS DICHLORHYDRATE ALLOPURINOL</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145544-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-746512</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>103</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>2500MG QAM AND 1000MG QPM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145545-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-ROCHE-746547</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061017</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145546-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-200915948EU</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>70.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>016273</drugauthorizationnumb>
        <drugdosagetext>DOSE AS USED: UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVESTIGATIONAL DRUG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVESTIGATIONAL DRUG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOLAZONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>2.5 MG 1X/DAY MON, WED AND FRI.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONTELUKAST SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145547-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-746630</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>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>DOSE: 15 MG/KG ON DAY 1.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPOTECAN</medicinalproduct>
        <drugdosagetext>DOSE: 2.3 MG/M2 FOR 05 CONSECUTIVE DAYS ON DAY 1-5</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIFEROL</medicinalproduct>
        <drugdosagetext>REPORTED: DOXECALCIFEROL</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>REPORTED: INSULIN ASPART</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIOTROPIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145548-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RU-ROCHE-742616</companynumb>
    <primarysource>
      <reportercountry>RUSSIAN FEDERATION</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>ALPHA 2 GLOBULIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IRON DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENOGASTRIC REFLUX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRODUODENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNOGLOBULINS INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SACROILIITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOTRETINOIN</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROMYCINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZOLIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLYOXIDONIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETASONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145549-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100913</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ROCHE-744513</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OSELTAMIVIR</medicinalproduct>
        <drugauthorizationnumb>021087</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>H1N1 INFLUENZA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145550-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-735518</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICES OESOPHAGEAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugdosagetext>FORM: INFUSION</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugdosagetext>FORM: INFUSION</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADEROGIL D3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM BICARBONATE</medicinalproduct>
        <drugdosagetext>TDD: 4 SPOONS /DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145551-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101128</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-BAXTER-2010BH027862</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>1007031</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101124</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145555-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-EISAI INC.-E3810-04225-SPO-JP</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARIET (RABEPRAZOLE)</medicinalproduct>
        <drugauthorizationnumb>020973</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101108</drugenddate>
        <drugtreatmentduration>90</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101108</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145556-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20101202785</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>DUROTEP MT</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145565-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028989</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>INTESTINAL FUNCTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145566-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH029106</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>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145567-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-SANOFI-AVENTIS-2010SA072655</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JEVTANA KIT</medicinalproduct>
        <drugauthorizationnumb>201023</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101014</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORGESIC TABLETS</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYOCHOLINE ^GLENWOOD^</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALNA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVALGIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMAL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101028</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145569-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006838</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1023549</drugbatchnumb>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101026</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145570-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20100807806</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>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145571-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH027561</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>HERNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145572-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-GENZYME-CLOF-1001286</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVOLTRA</medicinalproduct>
        <drugauthorizationnumb>021673</drugauthorizationnumb>
        <drugdosagetext>28.5 MG, QDX5</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101002</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>380 MG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IDARUBICIN HCL</medicinalproduct>
        <drugdosagetext>23 MG, QD</drugdosagetext>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100930</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROXIL</medicinalproduct>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101010</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101010</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101028</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMIPENEM</medicinalproduct>
        <drugdosagetext>2000 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101028</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101021</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugdosagetext>400 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101028</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145573-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA073362</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>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JEVTANA KIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>201023</drugauthorizationnumb>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100813</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JEVTANA KIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>201023</drugauthorizationnumb>
        <drugadministrationroute>051</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100813</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145577-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-002118</companynumb>
    <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>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145578-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-002592</companynumb>
    <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 INJURY</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>7145579-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-002539</companynumb>
    <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 INJURY</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>7145580-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-002470</companynumb>
    <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 INJURY</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>7145582-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-002531</companynumb>
    <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 INJURY</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>7145599-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100614</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0652682-00</companynumb>
    <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>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145600-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100611</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0652114-00</companynumb>
    <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>ERYTHROMYCIN BASE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145601-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100602</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0648623-00</companynumb>
    <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>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145602-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100514</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0645553-00</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>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145603-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100521</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0646736-00</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>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145604-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100609</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0650569-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DERMATITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145605-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100512</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0645093-00</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19800101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145606-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100608</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0651017-00</companynumb>
    <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>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145607-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100521</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0647304-00</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145608-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100602</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0648618-00</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>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145609-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100623</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0654230-00</companynumb>
    <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>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>BRONCHITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>RESPIRATORY TRACT INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145610-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100616</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0652842-00</companynumb>
    <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>ERYTHROMYCIN BASE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugdosagetext>EVERY 6 HOURS</drugdosagetext>
        <drugindication>IMPAIRED GASTRIC EMPTYING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MULTIPLE MEDICATIONS</medicinalproduct>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MULTIPLE MEDICATIONS</medicinalproduct>
        <drugindication>OSTEOPENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MULTIPLE MEDICATIONS</medicinalproduct>
        <drugindication>SARCOIDOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145611-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100625</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0653558-00</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>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</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>MULTI-VITAMIN</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>PRILOSEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugdosagetext>(0.5 PILL)</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugdosagetext>1500/1200 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>DETROL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CITRATE W/ VIT D</medicinalproduct>
        <drugdosagetext>500MG X 4 DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145612-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100729</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0660716-00</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>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN BASE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZOYL PEROXIDE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B</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>HUMIRA</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145613-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100630</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0654920-00</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>HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145614-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0657100-00</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145615-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0658173-00</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145616-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0656974-00</companynumb>
    <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>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19930101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145617-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0660565-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</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>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145618-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0658139-00</companynumb>
    <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>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN DOSE</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19860101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145619-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0656459-00</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAT RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19950101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145620-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100701</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0655038-00</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>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145621-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100625</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0654570-00</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19950101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145622-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100722</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0659190-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>149.82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN BASE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <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>PANTOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <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>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D3</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>NIASPAN</medicinalproduct>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145624-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100803</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0661659-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145625-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100722</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0660049-00</companynumb>
    <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>ERYTHROMYCIN BASE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145626-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100809</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0662675-00</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>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19850101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145627-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0659069-00</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>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145628-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0658783-00</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>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>EAR INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145629-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100806</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0663125-00</companynumb>
    <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>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VIRAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145630-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100804</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0662338-00</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145631-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100812</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0664032-00</companynumb>
    <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>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145632-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100816</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0664711-00</companynumb>
    <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>ERYTHROMYCIN BASE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145633-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MEDIMMUNE-MEDI-0011877</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>SYNAGIS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145634-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100804</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0661804-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145635-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0661036-00</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <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>ESCITALOPRAM</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN 70/30</medicinalproduct>
        <drugdosagetext>BID</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>7145636-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100812</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0663699-00</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</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145637-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100811</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0664382-00</companynumb>
    <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>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>BRONCHITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145638-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100816</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0664300-00</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>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145639-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-12982BP</companynumb>
    <primarysource>
      <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>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
      </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>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOVASCULAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>25 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN ([HUMALOG/] LANTUS)</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN (HUMALOG/[ LANTUS])</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145640-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100811</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0664001-00</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXPIRED DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>IMPAIRED GASTRIC EMPTYING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145641-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13046BP</companynumb>
    <primarysource>
      <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>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC 150</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021698</drugauthorizationnumb>
        <drugdosagetext>150 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145642-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100812</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0663844-00</companynumb>
    <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>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145643-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-12022BP</companynumb>
    <primarysource>
      <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>COMBIVENT</medicinalproduct>
        <drugbatchnumb>065569A</drugbatchnumb>
        <drugauthorizationnumb>020291</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101022</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugbatchnumb>065569A</drugbatchnumb>
        <drugauthorizationnumb>020291</drugauthorizationnumb>
        <drugdosagetext>24 PUF</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101022</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145644-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100819</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0665852-00</companynumb>
    <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>ERYTHROMYCIN BASE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145645-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-DE-06660DE</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM DIFFICILE COLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>1 ANZ</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COTRIM</medicinalproduct>
        <drugdosagetext>2 ANZ</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100618</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugdosagetext>1 ANZ</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL</medicinalproduct>
        <drugdosagetext>1 ANZ</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORASEMID</medicinalproduct>
        <drugdosagetext>1 ANZ</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHIMAZOLE</medicinalproduct>
        <drugdosagetext>1 ANZ</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTHYROIDISM</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FALITHROM</medicinalproduct>
        <drugdosagetext>DOSE BY VALUE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145646-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100816</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0665216-00</companynumb>
    <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 DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19950101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145647-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-12992BP</companynumb>
    <primarysource>
      <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 EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
        <drugbatchnumb>M09168,M09082</drugbatchnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100829</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
        <drugbatchnumb>M09168,M09082</drugbatchnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145648-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0671137-00</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145649-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0665880-00</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>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145650-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-09662BP</companynumb>
    <primarysource>
      <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>COMBIVENT</medicinalproduct>
        <drugbatchnumb>065528A,965071A,965077A,065533A</drugbatchnumb>
        <drugauthorizationnumb>020291</drugauthorizationnumb>
        <drugdosagetext>8 PUF</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145651-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0666851-00</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PHARYNGITIS STREPTOCOCCAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145652-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13002BP</companynumb>
    <primarysource>
      <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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC 75</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020520</drugauthorizationnumb>
        <drugdosagetext>150 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM + VITAMIN D</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145653-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100826</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0666296-00</companynumb>
    <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>ERYTHROMYCIN BASE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHARYNGITIS STREPTOCOCCAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19800101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145654-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-09889BP</companynumb>
    <primarysource>
      <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>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020884</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TRANSIENT ISCHAEMIC ATTACK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145655-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101013</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0678670-00</companynumb>
    <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>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145656-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13045BP</companynumb>
    <primarysource>
      <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>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145657-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101006</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0677168-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PHARYNGITIS STREPTOCOCCAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145658-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-12986BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</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>20101116</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145659-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100916</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0672107-00</companynumb>
    <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>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145660-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC.-2010-RO-01586RO</companynumb>
    <primarysource>
      <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>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED IMMUNE RESPONSIVENESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPOHYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>080352</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYGLANDULAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMAN GROWTH HORMONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESMOPRESSIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145661-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100825</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0666192-00</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTASIS</medicinalproduct>
        <drugdosagetext>0.05%</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>KERATOCONJUNCTIVITIS SICCA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145662-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0677694-00</companynumb>
    <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>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145663-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13014BP</companynumb>
    <primarysource>
      <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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</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>20101117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLECAINIDE ACETATE</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145664-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100910</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0670258-00</companynumb>
    <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 OF EYELID</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN BASE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145665-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100910</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0670893-00</companynumb>
    <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>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN FILMTAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100907</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145666-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0676040-00</companynumb>
    <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 GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145667-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0677708-00</companynumb>
    <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>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugdosagetext>SEVERAL YEARS AGO</drugdosagetext>
        <drugindication>SINUSITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145668-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100915</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0672095-00</companynumb>
    <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>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145669-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0671319-00</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN BASE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145670-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0677055-00</companynumb>
    <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>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145671-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101007</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0676702-00</companynumb>
    <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>ERYTHROMYCIN BASE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugindication>POSTPARTUM DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145672-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0675078-00</companynumb>
    <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>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145673-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100917</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0672507-00</companynumb>
    <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>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145674-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0680547-00</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>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugdosagetext>10/325MG</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VISTARIL</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTOCORT EC</medicinalproduct>
        <drugdosagetext>WEANING OFF FOR CROHN'S DISEASE</drugdosagetext>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARMOR THYROID</medicinalproduct>
        <drugdosagetext>DOESN'T TAKE BECAUSE OF STOMACH PROBLEMS RIGHT NOW</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>HASN'T TAKEN SINCE STOMACH PROBLEMS STARTED</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVESIN</medicinalproduct>
        <drugdosagetext>FOUR TIMES DAILY AS NEEDED</drugdosagetext>
        <drugindication>ABDOMINAL PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugindication>VOMITING</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145676-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0685123-00</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <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>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145677-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0684611-00</companynumb>
    <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>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145678-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0683095-00</companynumb>
    <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>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN BASE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145679-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101021</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0680882-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>EAR INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145680-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0685125-00</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145681-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0683518-00</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145682-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0681542-00</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>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN BASE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>ROSACEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REFLUX MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT CAL D 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>ATIVAN</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BP MEDICATION</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145683-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0680387-00</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugdosagetext>SEVERAL PILLS</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145684-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0684684-00</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>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19800101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTIFED</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145685-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0685657-00</companynumb>
    <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>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19670101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19670101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145686-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0684440-00</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>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAMELOR</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145687-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0682423-00</companynumb>
    <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>ERYTHROMYCIN BASE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145688-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0686330-00</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT LOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>EAR INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145689-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-09P-163-0496748-00</companynumb>
    <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 HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19880101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>BRONCHITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145690-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0686025-00</companynumb>
    <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>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145691-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0683906-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN BASE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145692-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0685681-00</companynumb>
    <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>WRONG DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145693-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0686480-00</companynumb>
    <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>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145694-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0686749-00</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>HEPATIC INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145695-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100311</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0632342-00</companynumb>
    <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>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN DOSE</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145696-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100312</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0632604-00</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>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145697-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0685680-00</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT ODOUR ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>LABYRINTHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>OTITIS MEDIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVALOG INSULIN</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145698-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0688010-00</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>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</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>FOLIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTACID TAB</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>7145699-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0685876-00</companynumb>
    <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>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>EAR INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145700-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0687522-00</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145701-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100415</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0639586-00</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145702-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100322</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0634325-00</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN BASE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19950101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145703-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100413</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0639228-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN BASE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145704-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100317</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0632998-00</companynumb>
    <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>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145705-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100322</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0634272-00</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN BASE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN DOSE</drugdosagetext>
        <drugindication>SINUS DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN BASE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145706-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100317</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0634013-00</companynumb>
    <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>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN DOSE</drugdosagetext>
        <drugindication>INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145707-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100315</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0633616-00</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>RESPIRATORY TRACT INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145708-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100426</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0641182-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145711-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100324</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0634526-00</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>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN BASE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145712-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100420</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0640166-00</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN BASE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145713-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100330</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0635336-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145714-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100416</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0639240-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugdosagetext>500 MG DAILY AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100326</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145715-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100429</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0642461-00</companynumb>
    <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>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>TOOTH ABSCESS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145716-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100325</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0634730-00</companynumb>
    <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>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN BASE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19900101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145717-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100318</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0634014-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN BASE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145718-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100513</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0645057-00</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROCIN LACTOBIONATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100415</drugstartdate>
      </drug>
      <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>MVT</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>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145719-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100331</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0637479-00</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>ERYTHROMYCIN BASE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145720-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100329</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0635265-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.548</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145721-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100603</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0643392-00</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>PRODUCT TASTE ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>WOUND</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100425</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BETA BLOCKERS</medicinalproduct>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145722-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100419</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0640252-00</companynumb>
    <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>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145723-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100426</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0640714-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN BASE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145724-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100416</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0640162-00</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>ERYTHROMYCIN ESTOLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145725-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100325</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0634591-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN BASE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061621</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145734-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897613A</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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101202</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145735-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0666239A</companynumb>
    <primarysource>
      <reportercountry>HONG KONG</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>PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLI</medicinalproduct>
        <drugbatchnumb>11966B</drugbatchnumb>
        <drugauthorizationnumb>021887</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145736-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-10P-020-0689468-00</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145737-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100324</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0635397-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>E.E.S.</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061905</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN DOSE</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145738-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100802</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0661657-00</companynumb>
    <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>E.E.S.</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061905</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145739-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101020</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0889318A</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>
      <patientweight>108.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OFATUMUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101013</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLORAZEPATE DIPOTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145740-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687750A</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OFATUMUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENDAMUSTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145741-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687953A</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OFATUMUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101108</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENDAMUSTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101108</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYELOSTIM</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAZOCIN</medicinalproduct>
        <drugdosagetext>4.5G THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANTIFUNGAL TREATMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugdosagetext>1600MG TWO TIMES PER WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101129</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145742-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>Z0003103B</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>67</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OFATUMUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>100MGM2 PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100309</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145743-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100506</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0643594-00</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>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>E.E.S.</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061905</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145744-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100923</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0673248-00</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>E.E.S.</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>061905</drugauthorizationnumb>
        <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>MALNUTRITION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSCAL 500 PLUS D</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>ZYRTEC</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULCOLAX</medicinalproduct>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRESCRIPTION LAXATIVE</medicinalproduct>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145745-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-SANOFI-AVENTIS-2010SA063495</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROTOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100902</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTECORTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100905</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145749-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0679359A</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 EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145750-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0679477A</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 MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145751-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0680395A</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 EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPECIAL SENSES CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugauthorizationnumb>020936</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145752-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0681275A</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>ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY VALVE STENOSIS CONGENITAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145753-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0681290A</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>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugauthorizationnumb>020936</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MACROBID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030825</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145754-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0681294A</companynumb>
    <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 VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145755-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0681515A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY VALVE STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145756-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0684465A</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>ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATENT DUCTUS ARTERIOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY VALVE STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145757-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0687237A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART DISEASE CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY VALVE STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT TACHYPNOEA OF THE NEWBORN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060321</drugenddate>
        <drugtreatmentduration>105</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145758-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0687242A</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>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEXTROCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART DISEASE CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE CONGENITAL ABNORMALITIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY VALVE STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINE MALFORMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>60MG PER DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145759-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0687531A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION VENTRICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EBSTEIN'S ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODYNAMIC INSTABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAVENTRICULAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL DRUGS AFFECTING FOETUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATENT DUCTUS ARTERIOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONEAL DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERY ATRESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOLFF-PARKINSON-WHITE SYNDROME CONGENITAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugauthorizationnumb>020936</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145760-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0700297A</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>ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL CARDIOVASCULAR ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERY STENOSIS CONGENITAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145761-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0748199A</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>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE CONGENITAL ABNORMALITIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER DEVELOPMENTAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG UNKNOWN</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDOMET</medicinalproduct>
        <drugdosagetext>250MG TWICE PER DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MACROBID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL ER</medicinalproduct>
        <drugdosagetext>120MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLDOPA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145762-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0751150A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHOGAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145763-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0752264A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>1.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPLASTIC LEFT HEART SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROTISING COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHUNT OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG AT NIGHT</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG AT NIGHT</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>20MG AS REQUIRED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugdosagetext>10MG THREE TIMES PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDODERM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145764-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0803637A</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>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC STROKE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
        <drugtreatmentduration>974</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145765-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0803845A</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>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071021</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145766-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0804109A</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041227</drugenddate>
        <drugtreatmentduration>259</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145767-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0804110A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061125</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145768-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0804111A</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>
      <patientsex>1</patientsex>
      <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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070715</drugenddate>
        <drugtreatmentduration>691</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145769-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0804113A</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>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>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145770-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0804114A</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>
      <patientweight>98.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041223</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145771-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0804124A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
        <drugtreatmentduration>717</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070524</drugenddate>
        <drugtreatmentduration>874</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145772-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0804160A</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>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>840</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145773-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0804177A</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>BRAIN STEM INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS CEREBRAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145774-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0847408A</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 MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145775-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0847409A</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>ATRIOVENTRICULAR BLOCK COMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145776-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0847422A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANKYLOGLOSSIA CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAILURE TO THRIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYLORIC STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FUSION SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145777-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0848937A</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>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145778-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0849263A</companynumb>
    <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>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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145779-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0849266A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</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>FEAR</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>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145780-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0851709A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUCTUS ARTERIOSUS PREMATURE CLOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPOPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIGHT VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugauthorizationnumb>020936</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050325</drugenddate>
        <drugtreatmentduration>300</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050919</drugenddate>
        <drugtreatmentduration>453</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN AND MINERAL PRENATAL SUPPLEMENT W/ FOLIC ACID CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145781-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0871147B</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROSCHISIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL RESECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER AND SMALL INTESTINE TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE ORGAN TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19981201</drugenddate>
        <drugtreatmentduration>257</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIORIDAZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN AND MINERAL PRENATAL SUPPLEMENT W/ FOLIC ACID CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145782-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0871544A</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>ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL CARDIOVASCULAR ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY VALVE STENOSIS CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIGHT VENTRICLE OUTFLOW TRACT OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145783-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0871948A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALLOT'S TETRALOGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145784-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0877372A</companynumb>
    <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>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugauthorizationnumb>020983</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145785-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0881192A</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>ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION VENTRICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>10MG AT NIGHT</drugdosagetext>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145786-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0882749A</companynumb>
    <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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLLAPSE OF LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXPIRED DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugbatchnumb>UNKNOWN,0ZP7936</drugbatchnumb>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145787-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0883769A</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>
      <patientweight>103.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVE BIRTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>300MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100714</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>200MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100715</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100421</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100421</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100421</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145788-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0884906A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL GROWTH RESTRICTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULTRASOUND SCAN ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugauthorizationnumb>020857</drugauthorizationnumb>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugindication>ANTIVIRAL TREATMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100603</drugenddate>
        <drugtreatmentduration>143</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREZISTA</medicinalproduct>
        <drugdosagetext>1200MG PER DAY</drugdosagetext>
        <drugindication>ANTIVIRAL TREATMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100603</drugenddate>
        <drugtreatmentduration>106</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugindication>ANTIVIRAL TREATMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100603</drugenddate>
        <drugtreatmentduration>106</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145789-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0885112A</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>100MGM2 CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145790-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0888046A</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>BEDRIDDEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugbatchnumb>R432388</drugbatchnumb>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVALIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145791-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0888257A</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>DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT EXPIRATION DATE ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT LOT NUMBER ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GOODYS EXTRA STRENGTH HEADACHE POWDER</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BC HEADACHE POWDER</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145792-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0890613A</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMATIC CRISIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugbatchnumb>R472338</drugbatchnumb>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145793-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0894732A</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>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANTLE CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROMACTA</medicinalproduct>
        <drugauthorizationnumb>022291</drugauthorizationnumb>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100714</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145794-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0894794A</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>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUMATRIPTAN SUCCINATE</medicinalproduct>
        <drugbatchnumb>CMA09001</drugbatchnumb>
        <drugauthorizationnumb>020080</drugauthorizationnumb>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100711</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DRAMAMINE</medicinalproduct>
        <drugindication>NAUSEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145795-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897390A</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>PROMACTA</medicinalproduct>
        <drugauthorizationnumb>022291</drugauthorizationnumb>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugindication>MYELOPROLIFERATIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100820</drugenddate>
        <drugtreatmentduration>52</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145796-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897426A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021654</drugauthorizationnumb>
        <drugdosagetext>4G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145797-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897501A</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>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROMACTA</medicinalproduct>
        <drugauthorizationnumb>022291</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROMIPLOSTIM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145798-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897584A</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>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROMACTA</medicinalproduct>
        <drugauthorizationnumb>022291</drugauthorizationnumb>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145799-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897674A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</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>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021654</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145800-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897764A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</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>7145801-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897768A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</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>7145802-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897776A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</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>7145803-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0897983A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITEK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145804-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0898132A</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>
      <patientweight>51.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugauthorizationnumb>020007</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugdosagetext>232MG EVERY TWO WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AXITINIB</medicinalproduct>
        <drugdosagetext>10MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101023</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRUCIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLCOVORIN</medicinalproduct>
        <drugdosagetext>600MG EVERY TWO WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PALONOSETRON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SCOPOLAMINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101031</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISACODYL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101029</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUMIN (HUMAN)</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101031</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUIDS</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145806-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0898160A</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>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021218</drugenddate>
        <drugtreatmentduration>400</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITRACAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145807-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0898168A</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>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROMACTA</medicinalproduct>
        <drugauthorizationnumb>022291</drugauthorizationnumb>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145808-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0898180A</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>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100708</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugauthorizationnumb>018473</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100708</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145809-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0898191A</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>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INHALATION THERAPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugauthorizationnumb>020983</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145810-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0898192A</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>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVE BIRTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE LABOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugauthorizationnumb>020857</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090822</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugdosagetext>200MGD PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090924</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREZISTA</medicinalproduct>
        <drugdosagetext>600MGD PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090924</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145811-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0898225A</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 MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugindication>PANIC ATTACK</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145812-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0898230A</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>ANOMALOUS PULMONARY VENOUS CONNECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145813-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0898392A</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>ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL TRICUSPID VALVE ATRESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DOUBLE OUTLET RIGHT VENTRICLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART DISEASE CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATENT DUCTUS ARTERIOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSPOSITION OF THE GREAT VESSELS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145814-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0898393A</companynumb>
    <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>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145815-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0898395A</companynumb>
    <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>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145816-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0898396A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145835-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0898422A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</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>7145836-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0898423A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</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>7145837-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0898424A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</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>7145838-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0898425A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</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>7145839-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0898426A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</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>7145840-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0898427A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</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>7145841-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0898428A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</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>7145842-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0898430A</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>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145843-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0898432A</companynumb>
    <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>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <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>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145844-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0898433A</companynumb>
    <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145845-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0898434A</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 DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC OPERATION</reactionmeddrapt>
      </reaction>
      <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>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145846-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0898435A</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>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145847-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0898436A</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>ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>40MG UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030808</drugenddate>
        <drugtreatmentduration>191</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145848-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0898437A</companynumb>
    <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 INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145849-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0359635A</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEXUAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOCIAL PHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugindication>PHOBIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021201</drugenddate>
        <drugtreatmentduration>170</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020820</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUROFEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020820</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CODEINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020820</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOFEPRAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020820</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COCAINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHAMPHETAMINE HYDROCHLORIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145850-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0533467A</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIARY CIRRHOSIS PRIMARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugdosagetext>1000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080815</drugenddate>
        <drugtreatmentduration>85</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASTUZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090514</drugenddate>
        <drugtreatmentduration>357</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145851-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0588099A</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>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <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>20090731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090804</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYKERB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugdosagetext>1250MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090824</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYKERB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugdosagetext>1000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091020</drugenddate>
        <drugtreatmentduration>44</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090804</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145852-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0664531A</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>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMAGNESAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TORSADE DE POINTES</reactionmeddrapt>
      </reaction>
      <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>20100410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100625</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>2400MGM2 PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100625</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BASEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145853-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0665764A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYKERB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090902</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145854-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0668538A</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>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <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>20090823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100130</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG MIX</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUNITRAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONTOMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TASMOLIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145855-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0670772A</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugdosagetext>1500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASTUZUMAB</medicinalproduct>
        <drugdosagetext>2MGK WEEKLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091126</drugenddate>
        <drugtreatmentduration>85</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>75MGM2 EVERY 3 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091105</drugenddate>
        <drugtreatmentduration>64</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145856-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0675047A</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>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugdosagetext>1000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GENITAL HERPES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100912</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
        <drugdosagetext>15MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METABOLIC ACIDOSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL FAILURE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDENALIN</medicinalproduct>
        <drugdosagetext>6MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENSURE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALNUTRITION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugdosagetext>1500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSEUDOMEMBRANOUS COLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100910</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARGAMATE</medicinalproduct>
        <drugdosagetext>75G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNASYN</medicinalproduct>
        <drugdosagetext>3G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FEBRILE NEUTROPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100917</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROACT</medicinalproduct>
        <drugdosagetext>2G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FEBRILE NEUTROPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100910</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIRSTCIN</medicinalproduct>
        <drugdosagetext>1G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FEBRILE NEUTROPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100902</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145857-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0683617A</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>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREATININE RENAL CLEARANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULAR FILTRATION RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE PERCENTAGE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN CELL VOLUME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL PERCENTAGE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVALO</medicinalproduct>
        <drugdosagetext>1IUAX PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATELEC</medicinalproduct>
        <drugdosagetext>1IUAX PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIGMART</medicinalproduct>
        <drugdosagetext>3IUAX PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>1IUAX PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYSLEE</medicinalproduct>
        <drugdosagetext>1IUAX PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROHYPNOL</medicinalproduct>
        <drugdosagetext>1IUAX PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
        <drugdosagetext>1IUAX PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ENTEROCOLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOFERMIN</medicinalproduct>
        <drugdosagetext>3G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ENTEROCOLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAL</medicinalproduct>
        <drugdosagetext>1IUAX PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ENTEROCOLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145858-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0684068A</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 PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN</medicinalproduct>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugdosagetext>4IUAX PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
        <drugdosagetext>1000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145859-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0684277A</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 CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101028</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOMYCIN</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugdosagetext>4IUAX PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICONAZOLE NITRATE</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
        <drugdosagetext>1500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DASEN</medicinalproduct>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101013</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENINAX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101015</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145860-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0684505A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMERGE</medicinalproduct>
        <drugauthorizationnumb>020763</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVIATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145861-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0684743A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugauthorizationnumb>020207</drugauthorizationnumb>
        <drugdosagetext>170MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100127</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUTROGIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100127</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAXIZON</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100129</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAXIZON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100208</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOZYM</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100129</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITRIZOLE</medicinalproduct>
        <drugdosagetext>20ML PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100131</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISODINE GARGLE</medicinalproduct>
        <drugadministrationroute>002</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100228</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTECADIN</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100215</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITRIZOLE</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100228</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145862-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0684977A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145863-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0686117A</companynumb>
    <primarysource>
      <reportercountry>GREECE</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN</medicinalproduct>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101114</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145864-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0686156A</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>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE SUBCUTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugauthorizationnumb>021345</drugauthorizationnumb>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101117</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RASENAZOLIN</medicinalproduct>
        <drugdosagetext>2G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101117</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLURBIPROFEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145865-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0686869A</companynumb>
    <primarysource>
      <reportercountry>FINLAND</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>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLIXOTIDE DISKUS</medicinalproduct>
        <drugauthorizationnumb>020833</drugauthorizationnumb>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145866-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0686985A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugauthorizationnumb>020857</drugauthorizationnumb>
        <drugdosagetext>2IUAX PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIRETROVIRAL THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101105</drugenddate>
        <drugtreatmentduration>107</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugdosagetext>4IUAX PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIRETROVIRAL THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101105</drugenddate>
        <drugtreatmentduration>107</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPTAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145867-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0686987A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>44</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFTAZIDIME</medicinalproduct>
        <drugauthorizationnumb>050634</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSEUDOMONAS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101117</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMOZYME</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100528</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLOMYCIN</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PSEUDOMONAS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090731</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CREON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANCREATIC INSUFFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN A</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANCREATIC INSUFFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANCREATIC INSUFFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANCREATIC INSUFFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070824</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145868-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0686990A</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>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN</medicinalproduct>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIVERTICULITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101120</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145869-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0686991A</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugbatchnumb>09M069</drugbatchnumb>
        <drugauthorizationnumb>062216</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALISKIREN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIOTROPIUM BROMIDE</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETASONE DIPROPIONATE</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145870-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687078A</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>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugdosagetext>6IUAX PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145871-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687135A</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KIVEXA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021652</drugauthorizationnumb>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100923</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100923</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100923</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANSATIPINE</medicinalproduct>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100923</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIRILENE</medicinalproduct>
        <drugdosagetext>2000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100923</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYAMBUTOL</medicinalproduct>
        <drugdosagetext>1200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100923</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIMIFON</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100923</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145872-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687159A</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>94.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugauthorizationnumb>020007</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>POSTOPERATIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LERCANIDIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145873-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687245A</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLAVAMOX</medicinalproduct>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugdosagetext>.505G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELTECT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145874-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687428A</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugbatchnumb>476444</drugbatchnumb>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145875-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687492A</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>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYKERB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145876-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687498A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugdosagetext>3000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101201</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOXOPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GASTER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYSLEE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145877-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687505A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugdosagetext>500MCG PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>EMPHYSEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEO-DUR</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EMPHYSEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>18MCG PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>EMPHYSEMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100704</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>5MCG PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100705</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145878-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687506A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN CHAPPED</reactionmeddrapt>
      </reaction>
      <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>20091021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100112</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>3000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100112</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE PHOSPHATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091215</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100112</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145879-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687657A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PIGMENTATION DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYKERB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugdosagetext>1250MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFLAMMATORY CARCINOMA OF THE BREAST</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>3600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100216</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>3000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPEMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100121</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145880-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687659A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugauthorizationnumb>020658</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145881-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687668A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>14.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS ASSOCIATED LYMPHOPROLIFERATIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HISTIOCYTOSIS HAEMATOPHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERAMMONAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugauthorizationnumb>020207</drugauthorizationnumb>
        <drugdosagetext>42MGM2 PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ALLOGENIC BONE MARROW TRANSPLANTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090415</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARA</medicinalproduct>
        <drugdosagetext>18MGM2 PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ALLOGENIC BONE MARROW TRANSPLANTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090412</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugdosagetext>35MGM2 PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ALLOGENIC BONE MARROW TRANSPLANTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090416</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUTROGIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090508</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugdosagetext>.3MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090426</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>6MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090420</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugdosagetext>7MG PER DAY</drugdosagetext>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090517</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>7MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090524</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIPERACILLIN SODIUM</medicinalproduct>
        <drugdosagetext>2G PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090417</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090526</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090628</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
        <drugdosagetext>.8MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090424</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAGMIN</medicinalproduct>
        <drugdosagetext>1ML PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090628</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUNGUARD</medicinalproduct>
        <drugdosagetext>15MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090615</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>15MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090417</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090628</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugdosagetext>15MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090420</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTIDAS</medicinalproduct>
        <drugdosagetext>160MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090612</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>.015G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090618</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugdosagetext>6MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090628</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090428</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN HCL</medicinalproduct>
        <drugdosagetext>1G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090502</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLYMYXIN-B-SULFATE</medicinalproduct>
        <drugdosagetext>1IUAX PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090521</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUNGIZONE</medicinalproduct>
        <drugdosagetext>800MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090628</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER</medicinalproduct>
        <drugdosagetext>.5G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090529</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAPP</medicinalproduct>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090626</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAKTAR</medicinalproduct>
        <drugdosagetext>1IUAX PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090628</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KAYTWO N</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090628</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145882-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687672A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DERMOVATE</medicinalproduct>
        <drugauthorizationnumb>021142</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145883-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687844A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN</medicinalproduct>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugdosagetext>9IUAX PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101126</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145884-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687912A</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>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145885-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060407</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0687972A</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>DILATREND</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145886-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>D0069614A</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugauthorizationnumb>020658</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TASMAR</medicinalproduct>
        <drugdosagetext>100MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUPRO</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MADOPAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIFROL</medicinalproduct>
        <drugdosagetext>.35MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STALEVO 100</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMANTADINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIRIBEDIL</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145887-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>Z0005226B</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPOTECAN</medicinalproduct>
        <drugauthorizationnumb>020981</drugauthorizationnumb>
        <drugdosagetext>10MG CYCLIC</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100819</drugstartdate>
      </drug>
      <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>20100803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugdosagetext>16MCG TWENTY FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>008</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>008</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>4MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>008</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>10MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugdosagetext>6MCG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>008</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100816</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPIVACAINE HCL</medicinalproduct>
        <drugdosagetext>4ML AS REQUIRED</drugdosagetext>
        <drugadministrationroute>008</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPIVACAINE HCL</medicinalproduct>
        <drugdosagetext>10MLH TWENTY FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>008</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDE</medicinalproduct>
        <drugdosagetext>20ML TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100809</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145888-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006863</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145889-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN LTD.-QUU445284</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMBOLISM ARTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MAJOR DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY SEQUESTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugindication>THROMBOCYTOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugdosagetext>500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugdosagetext>40 MG, QWK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTROSE</medicinalproduct>
        <drugdosagetext>3 ML, QWK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN                       /00097801/</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>20 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugdosagetext>1 DF, 2 TIMES/WK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugdosagetext>2 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESYREL</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>650 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
        <drugdosagetext>2 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARA-C</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECITABINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERGOCALCIFEROL</medicinalproduct>
        <drugdosagetext>50000 UNIT, QWK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGIC  MOUTHWASH</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugdosagetext>500 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VITAMIN C                          /00008001/</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145890-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ALLERGAN-1015565US</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>CHOROIDAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL DETACHMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUMIGAN</medicinalproduct>
        <drugauthorizationnumb>021275</drugauthorizationnumb>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145891-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-JNJFOC-20101201249</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>5</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>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING DRUNK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF-MEDICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND SECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>021180</drugauthorizationnumb>
        <drugdosagetext>NORELGESTROMIN 6 MG/ETHINYL ESTRADIOL 0.6 MG</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENPROCILINA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INFLUENZA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>L-OMBRIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INFECTION PARASITIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145895-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101014</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200942699NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.818</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPLASTIC CHOLECYSTOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE INJURIES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
        <drugtreatmentduration>1095</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OCELLA</medicinalproduct>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE AND ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>5/500 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPROZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENTERMINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145896-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101014</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200942699NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.818</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER CHOLESTEROLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPLASTIC CHOLECYSTOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE INJURIES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
        <drugtreatmentduration>1095</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OCELLA</medicinalproduct>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE AND ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>5/500 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPROZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENTERMINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145899-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ALLERGAN-1015557US</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>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUMIGAN</medicinalproduct>
        <drugauthorizationnumb>021275</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPHAGANA? P</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145900-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR201011006850</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>CROSS SENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100825</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100823</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPEGIC 1000</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLARAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPROSONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145901-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR201011006790</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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 DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM PROGRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145902-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ELI_LILLY_AND_COMPANY-BR201010004961</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145903-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ELI_LILLY_AND_COMPANY-IT201011007110</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>750 MG, PER CYCLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101027</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINITRAN                           /00003201/</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERSYL</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCAPTAN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOBIVON</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOTALIP</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACHIDOL</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145904-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ELI_LILLY_AND_COMPANY-BR201010003311</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>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145905-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ELI_LILLY_AND_COMPANY-ES201011006720</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
        <drugtreatmentduration>597</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugdosagetext>1 D/F, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145906-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201011007015</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>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugindication>LUNG ADENOCARCINOMA STAGE IV</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145907-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-ELI_LILLY_AND_COMPANY-NO201009001135</companynumb>
    <primarysource>
      <reportercountry>NORWAY</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>PENILE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PENILE VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>021368</drugauthorizationnumb>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145908-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE201011006837</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BILIARY NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>YELLOW SKIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145909-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ELI_LILLY_AND_COMPANY-IT201009006292</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>500 MG/M2, UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>500 MG/M2, UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>75 MG/M2, UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>AU 5, UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100827</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145910-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-10P-020-0687747-00</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBULA FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE ER</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021168</drugauthorizationnumb>
        <drugdosagetext>2500MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145911-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ALLERGAN-1015828US</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>CHOROIDAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL DETACHMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUMIGAN</medicinalproduct>
        <drugauthorizationnumb>021275</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>GLAUCOMA</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145916-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ALLERGAN-1015559US</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOROIDAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL DETACHMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUMIGAN</medicinalproduct>
        <drugauthorizationnumb>021275</drugauthorizationnumb>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>DEVELOPMENTAL GLAUCOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145927-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ALLERGAN-1014648US</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>CHOROIDAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL DETACHMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUMIGAN</medicinalproduct>
        <drugauthorizationnumb>021275</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>DEVELOPMENTAL GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091124</drugenddate>
        <drugtreatmentduration>902</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145931-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL324578</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1012740</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>12.5 MG, QWK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145932-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-SANOFI-AVENTIS-2010SA072636</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020496</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL/HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145933-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101006140</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugauthorizationnumb>021999</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOMIPHENE CITRATE</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145936-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100317</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0633938-00</companynumb>
    <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>ERYPED</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050207</drugauthorizationnumb>
        <drugdosagetext>400/5 ML  WITH MEALS AND AT HS</drugdosagetext>
        <drugindication>OESOPHAGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYPED</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050207</drugauthorizationnumb>
        <drugindication>HIATUS HERNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145937-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101001</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0676784-00</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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYPED</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050207</drugauthorizationnumb>
        <drugdosagetext>TWO OR THREE TIMES DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYPED</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050207</drugauthorizationnumb>
        <drugindication>IMPAIRED GASTRIC EMPTYING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYPED</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050207</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>INSULIN PUMP</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugindication>GASTRIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145938-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100422</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0641329-00</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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYPED</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050207</drugauthorizationnumb>
        <drugdosagetext>400 MG/5ML TAKE 2.5CC</drugdosagetext>
        <drugindication>GASTRIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100421</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>TOPRAL</medicinalproduct>
        <drugdosagetext>50MG IN AM ; 25MG @ HS</drugdosagetext>
        <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>LIPITOR</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>AMBIEN</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGEST GOLD</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZERTEC OTC</medicinalproduct>
        <drugindication>PRODUCT USED FOR 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>ESTER C</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145939-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100426</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0641936-00</companynumb>
    <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>ERYPED</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050207</drugauthorizationnumb>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100422</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>INSULIN PUMP PER SLIDING SCALE</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145940-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100924</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0674532-00</companynumb>
    <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>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050207</drugauthorizationnumb>
        <drugindication>OESOPHAGEAL DILATATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145941-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0678299-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>E.E.S.</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050207</drugauthorizationnumb>
        <drugdosagetext>2ML DAILY FOR SIX WEEKS</drugdosagetext>
        <drugindication>EYE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>NEBULIZER</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145942-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100728</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0661153-00</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>
      <patientweight>79.45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ETHYLSUCCINATE</medicinalproduct>
        <drugbatchnumb>73013CG21</drugbatchnumb>
        <drugauthorizationnumb>050207</drugauthorizationnumb>
        <drugdosagetext>200MG/5ML</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100728</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145943-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-746312</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LISTERIOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145944-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-616398</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FOCAL SEGMENTAL GLOMERULOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080906</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODESOXYCHOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOSIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMELIAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040708</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUFAST</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUFFERIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEPRENONE</medicinalproduct>
        <drugdosagetext>DRUG: CELOOP, DOSE FORM: MINUTE GRAIN.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080426</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145945-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-642268</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>CYTOMEGALOVIRUS CHORIORETINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITRECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1.25 MG, UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090323</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANIBIZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>0.05 ML, UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIAMCINOLONE ACETONIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090213</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145946-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-703965</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACUNAR INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugbatchnumb>B0003</drugbatchnumb>
        <drugdosagetext>FORM:INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugbatchnumb>B0003</drugbatchnumb>
        <drugdosagetext>DOSE: 4MG/KG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugbatchnumb>B0003</drugbatchnumb>
        <drugdosagetext>DOSE: 4MG/KG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100304</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugbatchnumb>B0003</drugbatchnumb>
        <drugdosagetext>DOSE: 4MG/KG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugbatchnumb>B0003</drugbatchnumb>
        <drugdosagetext>DOSE: 4MG/KG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM/VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ROUTINE HEALTH MAINTENANCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ROUTINE HEALTH MAINTENANCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL PM</medicinalproduct>
        <drugdosagetext>FREQUENCY: QHS, PRN</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080516</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMUCIL-2</medicinalproduct>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
        <drugdosagetext>DRUG NAME: DARVOCET-N-100</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugdosagetext>DRUG NAME: VICODIN 5/500</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050720</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VACCINE NOS</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DELSYM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100312</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN/ GUAIFENESIN/ NOSCAPINE/ PHENYLEPHRINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>FREQUENCY: Q 4-6 HOURS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM CITRATE</medicinalproduct>
        <drugdosagetext>DOSE: 1 BOTTLE X1</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100509</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugdosagetext>TDD: 8 PUFFS.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>TDD: 1-2 UNITS.  DRUG NAME: INSULIN NOVOLOG.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOSYN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>DRUG NAME: MORPHINE SULPHATE.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145947-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TH-ROCHE-727725</companynumb>
    <primarysource>
      <reportercountry>THAILAND</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>APLASIA PURE RED CELL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRCERA</medicinalproduct>
        <drugbatchnumb>H0462H02, H0466H01,H0467H01,H0468H+</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRCERA</medicinalproduct>
        <drugbatchnumb>H0462H02, H0466H01,H0467H01,H0468H+</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100504</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRCERA</medicinalproduct>
        <drugbatchnumb>H0462H02, H0466H01,H0467H01,H0468H+</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100805</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRCERA</medicinalproduct>
        <drugbatchnumb>H0462H02, H0466H01,H0467H01,H0468H+</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100822</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECORMON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETALOC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANIDIP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDERGINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugdosagetext>VYTORIN 10/40</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHALKCAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KIDMIN</medicinalproduct>
        <drugdosagetext>200 ML, HEMODIALYSIS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODA MINT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICPLEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145948-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR201011007068</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145949-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ELI_LILLY_AND_COMPANY-ES201011006773</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>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPAMIDA</medicinalproduct>
        <drugdosagetext>2.5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINVASTATINA</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOLOTIL</medicinalproduct>
        <drugdosagetext>UNK, EVERY 6 HRS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLLYRIUM</medicinalproduct>
        <drugdosagetext>UNK, 2/D</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DRY EYE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145950-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ELI_LILLY_AND_COMPANY-CA201010004461</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EURO-FER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>C-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145951-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ELI_LILLY_AND_COMPANY-CA201011006763</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>BLOOD COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101115</drugenddate>
        <drugtreatmentduration>483</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145952-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HU-ELI_LILLY_AND_COMPANY-HU201010006288</companynumb>
    <primarysource>
      <reportercountry>HUNGARY</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>HYPERKERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTOSE INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOCLASTIC VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERIPARATIDE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D3</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145953-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR201011006754</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>RETINAL DETACHMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100930</drugenddate>
        <drugtreatmentduration>113</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145954-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-741820</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPETITE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2A</medicinalproduct>
        <drugdosagetext>WEEK 11</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugdosagetext>WEEK 11</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100922</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145955-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENZYME-CLOF-1001285</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>38.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBILIRUBINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTRIGLYCERIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOLAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021673</drugauthorizationnumb>
        <drugdosagetext>UNK, 310 MG TOTAL DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100724</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>70 MG/M2, UNK, 5970 MG TOTAL DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100720</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145956-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-745419</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>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINAL ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>NOTE: DOSAGE IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELPLAT</medicinalproduct>
        <drugdosagetext>NOTE: DOSAGE IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>5-FU</medicinalproduct>
        <drugdosagetext>ROUTE: INTRAVENOUS BOLUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>5-FU</medicinalproduct>
        <drugdosagetext>ROUTE: INTRAVENOUS DRIP, NOTE: DOSAGE IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFOLINATE</medicinalproduct>
        <drugdosagetext>NOTE: DOSAGE IS UNCERTAIN</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145957-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-ROCHE-746194</companynumb>
    <primarysource>
      <reportercountry>FINLAND</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>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAGMIN</medicinalproduct>
        <drugdosagetext>DRUG REPORTED AS FRAGMIN 2500 IU/ML.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MESENTERIC VEIN THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100626</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMCONCOR</medicinalproduct>
        <drugdosagetext>BISOPROLOL HEMIFUMARAS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KERLON</medicinalproduct>
        <drugdosagetext>DRUG REPORTED AS BETAXOLOL HYDROCHLORIDE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>DRUG REPORTED AS OMEPRAZOL COPYFARM.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145958-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EG-ROCHE-746196</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 GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CONTRACTIONS INVOLUNTARY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2A</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2A</medicinalproduct>
        <drugdosagetext>DOSE, FREQUENCY NOT REPORTED.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED BMS-790052 (HCV NS5A INHIBITOR)</medicinalproduct>
        <drugdosagetext>THE TREATMENT WAS UNBLINDED AND PATIENT WAS RECEIVING BLINDED BMS-790052 (HCV NS5A INHIBITOR).</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101019</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145959-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061002</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-746229</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>PEGASYS</medicinalproduct>
        <drugdosagetext>ROUTE:INJECTION</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145960-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0032985</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>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080305</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145961-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-746300</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>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROPLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AOTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERESTA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145962-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-746712</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>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>FREQUENCY REPORTED AS DAY ONE EVERY 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugdosagetext>DOSE REPORTED AS 500 MG/M2, FREQUENCY REPORTED AS DAY 1 EVERY 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>DOSE REPORTED AS 75 MG/M2, FREQUENCY REPORTED AS DAY 1 EVERY 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CACIT D3</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145964-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101205</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-SANOFI-AVENTIS-2010SA073543</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090813</drugenddate>
        <drugtreatmentduration>70</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091021</drugenddate>
        <drugtreatmentduration>70</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145965-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-BAXTER-2010BH027449</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BURKITT'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BURKITT'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BURKITT'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BURKITT'S LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145966-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA058991</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>203</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG CARCINOMA CELL TYPE UNSPECIFIED STAGE III</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>0F009A</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>3-4 YEARS DOSE:40 UNIT(S)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTICLICK</medicinalproduct>
        <drugbatchnumb>N240</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>3-4 YEARS</drugdosagetext>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145967-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100909</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0670744-00</companynumb>
    <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>ERYTHROCIN STEARATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>060359</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145968-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0679056-00</companynumb>
    <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>ERYTHROMYCIN STEARATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>060359</drugauthorizationnumb>
        <drugindication>PHARYNGITIS STREPTOCOCCAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145969-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0668373-00</companynumb>
    <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>ERYTHROMYCIN STEARATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>060359</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145970-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0679150-00</companynumb>
    <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>ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN STEARATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>060359</drugauthorizationnumb>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19950101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145971-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100917</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0672502-00</companynumb>
    <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>ERYTHROMYCIN STEARATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>060359</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145972-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0670470-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS ALLERGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN STEARATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>060359</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145973-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PERRIGO-10US015207</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>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN SLOW RELEASE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>075077</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTENTIONAL OVERDOSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTENTIONAL OVERDOSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTENTIONAL OVERDOSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAFFEINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145974-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PERRIGO-10US015185</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN SLOW RELEASE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>075077</drugauthorizationnumb>
        <drugdosagetext>20,000 MG, SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COMPLETED SUICIDE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145975-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PERRIGO-10US015155</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>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>25-50 MG, 3-4 TIMES DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145976-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-AVENTIS-2010SA070602</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>49</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO OESOPHAGUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL SENSORY NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELPLAT</medicinalproduct>
        <drugauthorizationnumb>021759</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100528</drugenddate>
        <drugtreatmentduration>153</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELPLAT</medicinalproduct>
        <drugauthorizationnumb>021759</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100623</drugenddate>
        <drugtreatmentduration>153</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELPLAT</medicinalproduct>
        <drugauthorizationnumb>021759</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100714</drugenddate>
        <drugtreatmentduration>153</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELPLAT</medicinalproduct>
        <drugauthorizationnumb>021759</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100811</drugenddate>
        <drugtreatmentduration>153</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELPLAT</medicinalproduct>
        <drugauthorizationnumb>021759</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
        <drugtreatmentduration>153</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELPLAT</medicinalproduct>
        <drugauthorizationnumb>021759</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101006</drugenddate>
        <drugtreatmentduration>153</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELPLAT</medicinalproduct>
        <drugauthorizationnumb>021759</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101027</drugenddate>
        <drugtreatmentduration>153</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TS-1</medicinalproduct>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100528</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TS-1</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100623</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TS-1</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100714</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TS-1</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100811</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TS-1</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TS-1</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TS-1</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORIZON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERENACE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101117</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145978-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-CELGENEUS-087-21880-10111551</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101124</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LENADEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101024</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145979-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AMGEN-DEUSP2010007126</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>AMAUROSIS FUGAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>3 A?G/KG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145980-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-SANOFI-AVENTIS-2010SA066618</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>DIABETIC MASTOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN GLARGINE</medicinalproduct>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145981-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-SANOFI-AVENTIS-2010SA072331</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIPEN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON POLYMALTOSE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURAN T4</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145982-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH027449</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BURKITT'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BURKITT'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BURKITT'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BURKITT'S LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145983-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-CELGENEUS-167-50794-10113163</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>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDAZA</medicinalproduct>
        <drugauthorizationnumb>050794</drugauthorizationnumb>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100628</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145986-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-001543</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>ALEVE (CAPLET)</medicinalproduct>
        <drugbatchnumb>294929J</drugbatchnumb>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145987-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-001033</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>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</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>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145988-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-000972</companynumb>
    <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>THROAT IRRITATION</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>7145989-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-001474</companynumb>
    <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>ALEVE (CAPLET)</medicinalproduct>
        <drugbatchnumb>211270F</drugbatchnumb>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145990-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-001116</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>UNK UNK, IRR</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145994-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA073036</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>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE:50 UNIT(S)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTICLICK</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145998-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-US-EMD SERONO, INC.-7017783</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugbatchnumb>Y16A2618</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>SECONDARY PROGRESSIVE MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugbatchnumb>Y16A2618</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOOD SUPPLEMENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIOSAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7145999-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-US-EMD SERONO, INC.-7016479</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA MACROCYTIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugbatchnumb>Y16A6770</drugbatchnumb>
        <drugdosagetext>MULTIDOSE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100820</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugbatchnumb>Y16A6770</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugbatchnumb>Y16A6770</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIDE3</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN D DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIDE3</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146000-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-US-EMD SERONO, INC.-7025675</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</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>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugbatchnumb>Y15A3994</drugbatchnumb>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugbatchnumb>Y15A3994</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVANTRONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146001-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-US-EMD SERONO, INC.-7030773</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>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146002-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-US-EMD SERONO, INC.-7005729</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYSIPELAS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOLMES-ADIE PUPIL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOSOCOMIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100416</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONDROFLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXODUS (ESCITALOPRAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAVONID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDSIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HISPERIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146003-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-US-EMD SERONO, INC.-7013986</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARATHYROID CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSITIVITY OF TEETH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugbatchnumb>Y16A5407</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020415</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORIPURUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZELMAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146004-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-US-EMD SERONO, INC.-7008651</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE URINARY TRACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146005-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-HQWYE230001SEP05</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>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>004782</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRATAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146006-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-GB-WYE-G06813410</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>
      <patientweight>62.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABILE BLOOD PRESSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DUODENAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CO-CODAMOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLYCERYL TRINITRATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIDAZOLAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANCURONIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MUSCLE RELAXANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugdosagetext>1 DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020301</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLIXONASE</medicinalproduct>
        <drugdosagetext>1 UG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
        <drugindication>ANGINA PECTORIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146007-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-US-EMD SERONO, INC.-7030001</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>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UMBILICAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146008-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-US-EMD SERONO, INC.-7030120</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040505</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146009-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010007690</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WINRHO</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146012-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-CEPHALON-2010006178</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>APLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM DIFFICILE COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TREANDA</medicinalproduct>
        <drugauthorizationnumb>022249</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101011</drugenddate>
        <drugtreatmentduration>391</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146013-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20100804970</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52.16</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>ACD27011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>ACD27011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146014-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101200821</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>111</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>0RMA63701</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>0RMA63701</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM CD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRA-ZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICRO-K</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146015-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101201410</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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146016-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20101101502</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BENIGN PROSTATIC HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAROTIDECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146017-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20100709132</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</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>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS STREPTOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>0RMKA83502;0RMA63801</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BEHCET'S SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>0RMKA83502;0RMA63801</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>0RMKA83502;0RMA63801</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>0RMKA83502;0RMA63801</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>0RMKA83502;0RMA63801</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>0RMKA83502;0RMA63801</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRICANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSCOPAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILK OF MAGNESIA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146018-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-20785-10113246</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>NEPHRECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>020785</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090429</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146019-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-SANOFI-AVENTIS-2010SA070803</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>162</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APIDRA SOLOSTAR</medicinalproduct>
        <drugauthorizationnumb>021629</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACARBOSE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETIC NEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEZAFIBRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146020-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GENENTECH-310355</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BENIGN BREAST NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090629</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146023-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CZ-GENENTECH-308992</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>AUTOIMMUNE HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>375 MG/M2, Q3M</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090121</drugenddate>
        <drugtreatmentduration>92</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugindication>B-CELL LYMPHOMA RECURRENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146024-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101200597</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>107</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146025-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101200586</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146026-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-GENENTECH-310323</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>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101102</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146027-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-HQWYE216915MAY07</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>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146028-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2009176818</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF-MEDICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugauthorizationnumb>050784</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OROPHARYNGEAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081215</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146029-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-PFIZER INC-2010103771</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QRS COMPLEX PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>019787</drugauthorizationnumb>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>1200 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACENOCOUMAROL</medicinalproduct>
        <drugdosagetext>98 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
        <drugdosagetext>7.125 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COVERSYL</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOTALOL</medicinalproduct>
        <drugdosagetext>7200 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROMOCARD</medicinalproduct>
        <drugdosagetext>6000 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>800 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146030-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GENENTECH-310331</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146031-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-GENENTECH-310168</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>FACIAL BONES FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <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>SIMVASTATIN</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>PLENDIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMCONCOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TROMBYL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146032-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101128</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-JNJFOC-20101202740</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>MAINTENANCE DOSE: 2-2.99 MG/KG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146033-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101128</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-JNJFOC-20101200551</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</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>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146036-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13737BP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146037-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA068362</companynumb>
    <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 MALFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146038-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2010SE55012</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16960</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENISCUS LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101019</drugenddate>
        <drugtreatmentduration>841</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146039-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ASTRAZENECA-2010SE56320</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugdosagetext>1/4 OF THE TABLET EVERY OTHER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101125</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146040-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-AMGEN-AUSSP2010007116</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOTIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>2 A?G/KG, Q2WK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>600 A?G, ONE TIME DOSE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146041-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-AVENTIS-2010SA070430</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE MALFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>0F003A</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>0F003A</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>DOSE:18 UNIT(S)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146043-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101200828</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugdosagetext>25-50 MG.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146044-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-15414105</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>
      <patientweight>43</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BRIPLATIN</medicinalproduct>
        <drugauthorizationnumb>018057</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugauthorizationnumb>018768</drugauthorizationnumb>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146045-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BRISTOL-MYERS SQUIBB COMPANY-14913586</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>58</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>RECENT DOSE TAKEN ON 23DEC09.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEAD AND NECK CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>RECENT DOSE TAKEN ON 15DEC09.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEAD AND NECK CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091215</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CILENGITIDE</medicinalproduct>
        <drugdosagetext>RECENT DOSE TAKEN ON 23DEC09.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEAD AND NECK CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>RECENT DOSE TAKEN ON 15DEC09. TAKEN ON DAY 1 TO 4 OF THE CYCLE.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEAD AND NECK CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091215</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIOTROPIUM BROMIDE</medicinalproduct>
        <drugdosagetext>1 DF = 1 CAPSULE A DAY.</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APREPITANT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091119</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146046-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15418957</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugauthorizationnumb>009218</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146047-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-15414154</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>
      <patientweight>55</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BRIPLATIN</medicinalproduct>
        <drugauthorizationnumb>018057</drugauthorizationnumb>
        <drugdosagetext>NO OF COURSES:3</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugauthorizationnumb>018768</drugauthorizationnumb>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146048-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-15414147</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>
      <patientweight>44</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BRIPLATIN</medicinalproduct>
        <drugauthorizationnumb>018057</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA STAGE IV</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugauthorizationnumb>019763</drugauthorizationnumb>
        <drugdosagetext>INJ</drugdosagetext>
        <drugindication>LUNG ADENOCARCINOMA STAGE IV</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINDESINE</medicinalproduct>
        <drugdosagetext>INJ:DAY 1 AND 7</drugdosagetext>
        <drugindication>LUNG ADENOCARCINOMA STAGE IV</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146049-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-15420912</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugauthorizationnumb>009218</drugauthorizationnumb>
        <drugdosagetext>FOR SEVERAL YEARS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERESTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORLAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLUPRED</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146050-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-BRISTOL-MYERS SQUIBB COMPANY-15422926</companynumb>
    <primarysource>
      <reportercountry>FINLAND</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>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugindication>RESTLESSNESS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146051-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15429111</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugauthorizationnumb>009218</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146052-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201022181BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84.091</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugbatchnumb>206010C</drugbatchnumb>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>880 MG (DAILY DOSE), BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100928</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146053-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101008</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201022400BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>103.64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugbatchnumb>211140E</drugbatchnumb>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE 660 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101007</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146054-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201023624BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.182</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugbatchnumb>208020D</drugbatchnumb>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE 660 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOOTHACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101105</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146055-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201022358BCC</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>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugbatchnumb>10503</drugbatchnumb>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100924</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146056-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201023127BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.182</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugbatchnumb>271158H</drugbatchnumb>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>UNK, IRR</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146057-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201022284BCC</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugbatchnumb>214310H</drugbatchnumb>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>220 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146058-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201022180BCC</companynumb>
    <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>220 MG, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100927</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>440 MG, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100930</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>UNK UNK, IRR</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK UNK, IRR</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146059-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-000410</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>81 MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>THROMBOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVANE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146060-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-000272</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugauthorizationnumb>021317</drugauthorizationnumb>
        <drugdosagetext>81 MG, QOD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ISCHAEMIC HEART DISEASE PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146061-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100929</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201022223BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55.909</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>220 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID THERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAYER CHEWABLE LOW DOSE BABY ASPIRIN TABLET CHERRY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146062-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-001470</companynumb>
    <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>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>2 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146063-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201021884BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.909</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>BOTTLE COUNT 100S</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVASTIGMINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROSTATIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBIDOPA + LEVODOPA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GOUT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD PRESSURE ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM SILVER</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>B COMPLEX [B3,B6,B2,B1 HCL]</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROSTATIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146064-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-15219348</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>94</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GILBERT'S SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APIXABAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EMBOLISM ARTERIAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100722</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>2-4 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EMBOLISM ARTERIAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100721</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugindication>EMBOLISM ARTERIAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EMBOLISM ARTERIAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100722</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUTAFLOR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100422</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146065-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA073246</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>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>C768</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>C768</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE:70 UNIT(S)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146068-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-SANOFI-AVENTIS-2010SA073354</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEVICE MALFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>0F254A</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>0F254A</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146072-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-BAXTER-2010BH025136</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>CARDIAC DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHYSIOSOL IN PLASTIC CONTAINER</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100926</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146075-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010007572</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146076-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HU-AMGEN-HUNSP2010003489</companynumb>
    <primarysource>
      <reportercountry>HUNGARY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>APLASIA PURE RED CELL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>1022211</drugbatchnumb>
        <drugdosagetext>50 A?G, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100408</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERRLECIT                          /01099901/</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>3 MG, QWK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100408</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMID                          /00032601/</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OLIGURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100408</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONTROLOC                          /01263201/</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAPREL MR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146077-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU418586</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>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>6 MG, Q3WK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100614</drugenddate>
        <drugtreatmentduration>63</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100603</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACLITAXEL PTOTEIN-BOUND PARTICLES FOR INJECTABLE SUSPENSION</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENAZOPYRIDINE HCL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABRAXANE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100603</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMEND                              /01627301/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESNA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146078-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-15127764</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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 ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugbatchnumb>108413</drugbatchnumb>
        <drugdosagetext>DOSE REDUCED TO 2-3RD OF 5MG TAB(AUG/SEP2010) AND TOOK 1/2TAB ONE DAY ALTER WITH 1TAB NEXT DAY.</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugbatchnumb>108413</drugbatchnumb>
        <drugdosagetext>DOSE REDUCED TO 2-3RD OF 5MG TAB(AUG/SEP2010) AND TOOK 1/2TAB ONE DAY ALTER WITH 1TAB NEXT DAY.</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146093-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-1011USA01714</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>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugauthorizationnumb>011664</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC AMYLOIDOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146094-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1011USA00041</companynumb>
    <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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100913</drugenddate>
        <drugtreatmentduration>440</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146095-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-1011USA01769</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>021445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101122</drugenddate>
        <drugtreatmentduration>52</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEDIEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOFU-TSUSHO-SAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALBLOCK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146096-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0810USA04871</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>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTINIC KERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRUXISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORNEAL ABRASION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCORIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED FASTING GLUCOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTATIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIODONTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICULAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROSACEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVIAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPOROMANDIBULAR JOINT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHONDROITIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAXSEED</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146097-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0705USA04136</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>ACTINOMYCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDIX DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR SPINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE INJURIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL TORUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEITIS DEFORMANS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIODONTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST LAMINECTOMY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULPITIS DENTAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICULAR CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICULITIS LUMBOSACRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SACROILIITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEBORRHOEIC KERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SIALOADENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEITIS DEFORMANS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070226</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146098-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101013</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-1010USA01944</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>FEMUR FRACTURE</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>7146099-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1011USA00818</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>CEREBELLAR ATAXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISENTRESS</medicinalproduct>
        <drugauthorizationnumb>022145</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETRAVIRINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146100-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0903USA02032</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>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD HOMOCYSTEINE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRAUMATIC HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070201</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146101-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1004USA00573</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GROIN PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR SPINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELITIS TRANSVERSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLOGICAL DECOMPENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL TORUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUBIS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT BEARING DIFFICULTY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE DENSITY DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071201</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071201</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE DENSITY DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090801</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146102-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1002USA03937</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>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COSOPT</medicinalproduct>
        <drugbatchnumb>0898400</drugbatchnumb>
        <drugauthorizationnumb>020869</drugauthorizationnumb>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090619</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COSOPT</medicinalproduct>
        <drugauthorizationnumb>020869</drugauthorizationnumb>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COSOPT</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>INTRAOCULAR PRESSURE INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146103-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1011USA01668</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>
      <patientweight>81</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMEND</medicinalproduct>
        <drugauthorizationnumb>021549</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALOXI</medicinalproduct>
        <drugbatchnumb>30000636</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101104</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON PHOSPHATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101104</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IVEMEND</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101104</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146104-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-1011USA01713</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugauthorizationnumb>011664</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC AMYLOIDOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146105-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1011USA03363</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A723779C</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146106-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1011USA03881</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>83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC EMBOLUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULAR FILTRATION RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDROCEPHALUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO SPINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>AORTIC EMBOLUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OEDEMA PERIPHERAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORNIFLUMATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>URINARY TRACT DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAMIDRONATE DISODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RENAL CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146107-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0905USA02778</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>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIODONTAL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <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>20060101</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146108-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1004USA03498</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>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BARRETT'S OESOPHAGUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER RECURRENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERUMEN IMPACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMORAL NECK FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCCULT BLOOD POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL TORUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS EXTERNA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SIALOADENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DEPOSIT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080201</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIVELLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071201</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORMONES (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146109-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-1011USA01634</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>31</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACINETOBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugauthorizationnumb>019462</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICAFUNGIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPHA1-PROTEINASE INHIBITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PANCREATITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPHA1-PROTEINASE INHIBITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DISSEMINATED INTRAVASCULAR COAGULATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEICOPLANIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFEPIME</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146110-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0911USA03514</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>86</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACARODERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA POSTOPERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBULA FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FORMICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE NONUNION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SPRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR VERTEBRAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MORTON'S NEUROMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ONYCHOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLANTAR FASCIITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLOLISTHESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 1 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE LEIOMYOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STRESS FRACTURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010301</drugenddate>
        <drugtreatmentduration>63</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061205</drugenddate>
        <drugtreatmentduration>70</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010301</drugenddate>
        <drugtreatmentduration>63</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061205</drugenddate>
        <drugtreatmentduration>70</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19830101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOZOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146111-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1011USA03782</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146112-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-1012USA00703</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>CROUP INFECTIOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugauthorizationnumb>011664</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROUP INFECTIOUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146113-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1012USA00946</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>92</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146114-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1010USA00475</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>101</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugauthorizationnumb>011664</drugauthorizationnumb>
        <drugdosagetext>DAY 1,2,3,4,8,9,11,12 PER CYCLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100923</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugauthorizationnumb>011664</drugauthorizationnumb>
        <drugdosagetext>DAY 1,2,4,5,8,9,11,12 PER CYCLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101112</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugdosagetext>QD 1-21 PER CYCLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100923</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>DAYS 1,4,8,11 PER CYCLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100923</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>DAYS 1,4,8,11 PER CYCLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101112</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146115-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1006USA02459</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>
      <patientweight>133</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMEND</medicinalproduct>
        <drugauthorizationnumb>021549</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100413</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMEND</medicinalproduct>
        <drugauthorizationnumb>021549</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMEND</medicinalproduct>
        <drugauthorizationnumb>021549</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMEND</medicinalproduct>
        <drugauthorizationnumb>021549</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100503</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100503</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESNA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENAZOPYRIDINE HCL TAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146116-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0802USA00106</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>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA POSTOPERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER TRABECULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE EROSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTHESOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EUSTACHIAN TUBE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE STRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS ADHESIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHLEBITIS DEEP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011201</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAMELOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146117-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1010USA00021</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>CEREBELLAR ATAXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISENTRESS</medicinalproduct>
        <drugauthorizationnumb>022145</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISENTRESS</medicinalproduct>
        <drugauthorizationnumb>022145</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISENTRESS</medicinalproduct>
        <drugauthorizationnumb>022145</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETRAVIRINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146118-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GENZYME-THYM-1002139</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>44</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE GRAFT VERSUS HOST DISEASE IN SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS VIRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAVENTRICULAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090816</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDARABINE PHOSPHATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090818</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMOSETRON HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090819</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090818</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090819</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPROSTADIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090824</drugenddate>
        <drugtreatmentduration>51</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090824</drugenddate>
        <drugtreatmentduration>51</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FILGRASTIM (GENETICAL RECOMBINATION)</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>COLONY STIMULATING FACTOR THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090920</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICAFUNGIN SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANTIFUNGAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090917</drugenddate>
        <drugtreatmentduration>67</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIRENZEPINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091017</drugenddate>
        <drugtreatmentduration>94</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091023</drugenddate>
        <drugtreatmentduration>96</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GANCILCOVIR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091108</drugenddate>
        <drugtreatmentduration>100</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE SODIUM SUCCINATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091005</drugenddate>
        <drugtreatmentduration>59</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE SODIUM SUCCINATE</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMINOACETIC ACID, CYSTEINE, GLYCYRRHIZIC ACID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>LIVER DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090909</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESNA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090818</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090818</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090819</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HAPTOGLOBINS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090821</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091023</drugenddate>
        <drugtreatmentduration>96</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETOXAZOL MED TRIMETOPRIM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANTIFUNGAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091202</drugenddate>
        <drugtreatmentduration>58</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBAMIPIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>GASTRITIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100107</drugenddate>
        <drugtreatmentduration>82</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALACICLOVIR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091119</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146120-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>ES-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13587YA</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RETROGRADE EJACULATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNIC OCAS ORODISPERSABLE</medicinalproduct>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146121-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-01284BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.38</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE-COMPULSIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOLOGICAL GAMBLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146122-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13016BP</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</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>20101115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146123-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13036BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146124-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13086BP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146125-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13090BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METACAM ORAL SUSPENSION</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021530</drugauthorizationnumb>
        <drugadministrationroute>031</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101117</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146126-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13065BP</companynumb>
    <primarysource>
      <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>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146127-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13015BP</companynumb>
    <primarysource>
      <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>THYROID 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>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARZOLAMIDE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICATION NOT FURTHER SPECIFIED</medicinalproduct>
        <drugindication>MACULAR DEGENERATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146128-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13188PF</companynumb>
    <primarysource>
      <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>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146129-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13103BP</companynumb>
    <primarysource>
      <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>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>150 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101122</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146130-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-12985BP</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</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>20101109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </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>20101116</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HCL</medicinalproduct>
        <drugindication>ARRHYTHMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugindication>OSTEOPENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPLEX B</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRANBERRY PILL</medicinalproduct>
        <drugindication>URINARY TRACT INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146131-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13109BP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146133-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010007558</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABSCESS INTESTINAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLIA</medicinalproduct>
        <drugindication>OSTEOPOROSIS POSTMENOPAUSAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN A</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146134-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-ASTRAZENECA-2010SE50524</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23967</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>69</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100830</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LENALIDOMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100830</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LENALIDOMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIBIOTIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100826</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEXANE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146135-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ASTRAZENECA-2010SE53133</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HIP ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146136-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2010SE57587</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>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070418</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPHA-ADRENOCEPTOR BLOCKING AGENTS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146141-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ASTRAZENECA-2010SE56375</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>GASTRIC OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146142-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ASTRAZENECA-2010SE55990</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>021399</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100817</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FROBEN</medicinalproduct>
        <drugindication>BACK DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146146-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-JPNCT2010004878</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL VARICES HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANITUMUMAB</medicinalproduct>
        <drugdosagetext>2</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101026</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHISTAMINES</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIRUDOID SOFT</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146147-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-TEVA-258594ISR</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN</medicinalproduct>
        <drugauthorizationnumb>063097</drugauthorizationnumb>
        <drugindication>HODGKIN'S DISEASE MIXED CELLULARITY STAGE UNSPECIFIED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLEOMYCIN</medicinalproduct>
        <drugindication>HODGKIN'S DISEASE MIXED CELLULARITY STAGE UNSPECIFIED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACARBAZINE</medicinalproduct>
        <drugindication>HODGKIN'S DISEASE MIXED CELLULARITY STAGE UNSPECIFIED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINBLASTINE</medicinalproduct>
        <drugindication>HODGKIN'S DISEASE MIXED CELLULARITY STAGE UNSPECIFIED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146148-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028422</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146149-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-TEVA-256262ISR</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>074656</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100803</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>074656</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100803</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON HYDROCHLORIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APREPITANT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100427</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100630</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146150-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-TEVA-256871ISR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugauthorizationnumb>020622</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146151-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
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    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7030029</companynumb>
    <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 OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100715</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146152-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
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    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7013034</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>CARDIAC PACEMAKER INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</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>20090810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100310</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100318</drugstartdate>
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        <drugenddate>20100420</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
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        <drugstartdate>20100801</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugindication>FATIGUE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENABLEX</medicinalproduct>
        <drugindication>MICTURITION URGENCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146153-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ABBOTT-10P-083-0686504-00</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLACID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugdosagetext>1 GRAM DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1 GRAM DAILY</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100625</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146154-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-10P-167-0685671-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146155-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-10P-056-0660110-01</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP PHASE RHYTHM DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021906</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100506</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021906</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COAPROVEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EMBOLISM ARTERIAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100510</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOPRAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OESOPHAGITIS HAEMORRHAGIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOMIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091130</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146156-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7029951</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146157-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-430009J09USA</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>GASTROENTERITIS VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVANTRONE</medicinalproduct>
        <drugauthorizationnumb>019297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVANTRONE</medicinalproduct>
        <drugauthorizationnumb>019297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090720</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146158-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-231875J10USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRAUMATIC LUNG INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEEP VEIN THROMBOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIZANIDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEART DISEASE CONGENITAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEEP VEIN THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ECZEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CATHETER PLACEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DANTROLENE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUTALBITAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEXOFENADINE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146159-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7015654</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100827</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEART PILL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugindication>NEURALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146160-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-GBRCT2010004715</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANITUMUMAB</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>OESOPHAGEAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100825</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100825</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100825</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>1 G, PRN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE</medicinalproduct>
        <drugdosagetext>UNK UNK, PRN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100825</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146161-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028898</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>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101127</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146162-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7029928</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091013</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146163-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7030380</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</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>SAIZEN</medicinalproduct>
        <drugauthorizationnumb>019764</drugauthorizationnumb>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146164-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-232488J09USA</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>CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091001</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED STEROIDS</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED ARTHRITIS MEDICATION</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146165-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-231335J10USA</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>ALCOHOLIC LIVER DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146166-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7029924</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONGENITAL CYSTIC KIDNEY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146167-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7023696</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CERVICAL SPINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100302</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATIONS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146168-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7029826</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPRELAN</medicinalproduct>
        <drugindication>BURSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146169-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAXTER-2010BH029349</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101128</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146170-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101202591</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugauthorizationnumb>021999</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOCALIN</medicinalproduct>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOCALIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146172-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7014110</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BEDRIDDEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080605</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146173-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7024113</companynumb>
    <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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146174-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101008</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-CELGENEUS-167-21880-08111434</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANTLE CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR FLARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081218</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146175-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010DK72177</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APICAL GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTONOMIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>80 MG</drugdosagetext>
        <drugindication>BLOOD PRESSURE DIASTOLIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>XYLOPLYIN DENTAL ADRENALIN</medicinalproduct>
        <drugdosagetext>20 MG/ML/12.5 ?G/ML</drugdosagetext>
        <drugindication>ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>5 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146176-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010MX80449</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146177-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US05871</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>ABDOMINAL ADHESIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADJUSTMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CENTRAL NERVOUS SYSTEM LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGRAPHIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSTHYMIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PIGMENTATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>READING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN PAPILLOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugauthorizationnumb>021200</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146178-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010FR80429</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ACIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALSARTAN  AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100823</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146179-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010IE80272</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146180-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR80474</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 INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugbatchnumb>UNK.</drugbatchnumb>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146181-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0682510-00</companynumb>
    <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>E-MYCIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>060272</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146182-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100802</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0661654-00</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>E-MYCIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>060272</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146183-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010MX82184</companynumb>
    <primarysource>
      <reportercountry>MEXICO</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>INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugdosagetext>1 TABLET (160/12.5 MG) DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146184-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR80480</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>KNEE OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>1 DF, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORASEQ</medicinalproduct>
        <drugdosagetext>2 INHALATIONS DAILY</drugdosagetext>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RASILEZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146185-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US80862</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugindication>MASTOCYTOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CROMOLYN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146186-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR80963</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugdosagetext>1 TABLET DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>1 TABLET DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAZEN</medicinalproduct>
        <drugdosagetext>1 TABLET DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146187-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR80965</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</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>RASILEZ</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146188-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010AU18061</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD AMYLASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STI571/CGP57148B T35717+TAB</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>600MG DAILY DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101027</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STI571/CGP57148B T35717+TAB</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STI571/CGP57148B T35717+TAB</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101126</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146189-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR80461</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE AND VALSARTAN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021990</drugauthorizationnumb>
        <drugdosagetext>80/5MG, 1 TABLET A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>30MG  1 TABLET A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>500MG, 1 TABLET A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146190-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP68721</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</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>20100727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100820</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INTERFERON ALFA</medicinalproduct>
        <drugdosagetext>5000000 IU</drugdosagetext>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090622</drugenddate>
        <drugtreatmentduration>673</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TECELEUKIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090622</drugenddate>
        <drugtreatmentduration>673</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUNITINIB MALATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100726</drugenddate>
        <drugtreatmentduration>125</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SORAFENIB TOSILATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100216</drugenddate>
        <drugtreatmentduration>239</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146191-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010FR80482</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RASILEZ</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>150 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146192-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010DE82429</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN TRIPLE DTR+</medicinalproduct>
        <drugauthorizationnumb>022314</drugauthorizationnumb>
        <drugdosagetext>10/160/12.5 MG,</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100727</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN TRIPLE DTR+</medicinalproduct>
        <drugauthorizationnumb>022314</drugauthorizationnumb>
        <drugdosagetext>10/320/25 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>HALF DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>HALF DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORASEMIDE</medicinalproduct>
        <drugdosagetext>20 MG, HALF TABET, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOXONIDINE</medicinalproduct>
        <drugdosagetext>ONE TABLET, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORMOTEROL FUMARATE</medicinalproduct>
        <drugdosagetext>TWICE DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLAC</medicinalproduct>
        <drugdosagetext>75 , UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>600, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BERODUAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRANGIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEP</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugdosagetext>50 MCG/500 MCG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146193-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP80980</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>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146194-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US80048</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146195-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2010IE01240</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLLAPSE OF LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG SQUAMOUS CELL CARCINOMA STAGE III</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-SMALL CELL LUNG CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>100 MG MANE, 200 MG NOCTE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146196-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US81289</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146197-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010GT82294</companynumb>
    <primarysource>
      <reportercountry>GUATEMALA</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>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugdosagetext>160/12.5 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146198-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2010GB13445</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDOMETHACIN (NGX)</medicinalproduct>
        <drugauthorizationnumb>070673</drugauthorizationnumb>
        <drugdosagetext>75 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146199-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2010DE13193</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOAMING AT MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXEPIN HCL</medicinalproduct>
        <drugauthorizationnumb>070825</drugauthorizationnumb>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATRIPLA</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146200-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2010IT13391</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugauthorizationnumb>076959</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE (NGX)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146201-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2010GB13455</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>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugauthorizationnumb>076086</drugauthorizationnumb>
        <drugdosagetext>150 MG, TOTAL</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CANDIDIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOTRIMAZOLE</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugindication>CANDIDIASIS</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CILEST</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146202-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2010PL13383</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNITROPE</medicinalproduct>
        <drugauthorizationnumb>021426</drugauthorizationnumb>
        <drugdosagetext>0.03 MG/KG/DOSE DAILY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPOPITUITARISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146203-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2010SI12325</companynumb>
    <primarysource>
      <reportercountry>SLOVENIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAM (NGX)</medicinalproduct>
        <drugauthorizationnumb>071193</drugauthorizationnumb>
        <drugdosagetext>1.25 MG, QD (IN THE EVENING)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAM (NGX)</medicinalproduct>
        <drugauthorizationnumb>071193</drugauthorizationnumb>
        <drugdosagetext>0.25 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERSEN FORTE (NGX)</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORMIDOL</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146204-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2010FR13470</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFAMPICIN</medicinalproduct>
        <drugauthorizationnumb>064150</drugauthorizationnumb>
        <drugdosagetext>900 MG, BID (THREE CAPSULE IN THE MORNING AND EVENING)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ENDOCARDITIS STAPHYLOCOCCAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101105</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>1 G, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ENDOCARDITIS STAPHYLOCOCCAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101027</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>2.5 G, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101028</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>3 G, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101030</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>2.5 G, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101031</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
        <drugdosagetext>250 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ENDOCARDITIS STAPHYLOCOCCAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101031</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL</medicinalproduct>
        <drugdosagetext>10 MG IN MORNING AND THE EVENING</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101105</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>1 SCORED TABLET IN THE MORNING AND 1 SCORED TABLET AT LUNCH)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAHOR</medicinalproduct>
        <drugdosagetext>40 MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugdosagetext>1 DF/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZANTAC</medicinalproduct>
        <drugdosagetext>300 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE W/FORMOTEROL FUMARATE</medicinalproduct>
        <drugdosagetext>2 PUFFS/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146205-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2010GB13449</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE (NGX)</medicinalproduct>
        <drugauthorizationnumb>065032</drugauthorizationnumb>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOWER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101114</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONIC ACID</medicinalproduct>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>250 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOWER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICHEW D3</medicinalproduct>
        <drugdosagetext>1DF/1DAYS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>15 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146206-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA062417</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>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBULOINTERSTITIAL NEPHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>009768</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCLERODERMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE/FORMOTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146207-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US78309</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPICE CARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146208-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-EISAI INC.-E2020-08126-SPO-US</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>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugauthorizationnumb>020690</drugauthorizationnumb>
        <drugdosagetext>CUTTING 10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146209-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7027723</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101112</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146210-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP81598</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STARSIS</medicinalproduct>
        <drugauthorizationnumb>021204</drugauthorizationnumb>
        <drugdosagetext>180 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146211-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2009DE03153</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugdosagetext>NO TREATMENT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146212-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GENENTECH-310486</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAND FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146213-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-258049USA</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>COPAXONE</medicinalproduct>
        <drugauthorizationnumb>020622</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146214-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GENENTECH-280383</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMBOLIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC STROKE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080404</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URBASON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUTHYROX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>15 MG, 1/WEEK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146215-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13114BP</companynumb>
    <primarysource>
      <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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>001697</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>001697</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVETIRACETAM</medicinalproduct>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146216-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GENENTECH-309761</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RETINAL DETACHMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL TEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146217-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101120</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13108BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.02</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERUCTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>001452</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>HYPERTRIGLYCERIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>GOUT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146218-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13104BP</companynumb>
    <primarysource>
      <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>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF FOREIGN BODY</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>20101118</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146219-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13105BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>REGURGITATION</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>20101121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOCONAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146220-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13179BP</companynumb>
    <primarysource>
      <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>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>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
        <drugindication>DIZZINESS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146221-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROXANE LABORATORIES, INC.-2010-DE-06746GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugauthorizationnumb>080352</drugauthorizationnumb>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugindication>ACQUIRED EPIDERMOLYSIS BULLOSA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugindication>ACQUIRED EPIDERMOLYSIS BULLOSA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146222-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13181BP</companynumb>
    <primarysource>
      <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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</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>20101120</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146223-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13182BP</companynumb>
    <primarysource>
      <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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>001452</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOVASCULAR EVENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOVASCULAR EVENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146224-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13178BP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>803</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</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>20101117</drugstartdate>
      </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>20101104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugindication>DEMENTIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugindication>DEMENTIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146225-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13127BP</companynumb>
    <primarysource>
      <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>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</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>20101116</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146226-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13183BP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCREASED UPPER AIRWAY SECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146227-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13184BP</companynumb>
    <primarysource>
      <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>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>001700</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>001700</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146228-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13190BP</companynumb>
    <primarysource>
      <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>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101119</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>7146229-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-GENENTECH-310780</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>EPSTEIN-BARR VIRUS ASSOCIATED LYMPHOPROLIFERATIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAZE PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>375 MG/M2, 1/WEEK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>EPSTEIN-BARR VIRUS ASSOCIATED LYMPHOPROLIFERATIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSANT DRUG THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSANT DRUG THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>IMMUNOSUPPRESSANT DRUG THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146230-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GENENTECH-310484</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>3</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>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONTELUKAST</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146231-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-ASTRAZENECA-2010SE57745</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</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>CONGESTIVE CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146232-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-JP-WYE-H18312210</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>44.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANCARON</medicinalproduct>
        <drugauthorizationnumb>018972</drugauthorizationnumb>
        <drugdosagetext>100 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
        <drugtreatmentduration>782</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANCARON</medicinalproduct>
        <drugauthorizationnumb>018972</drugauthorizationnumb>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORASEMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERSYL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TICLOPIDINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRANDOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN R</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146233-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-HQWYE804103FEB04</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>AKATHISIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INDIFFERENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>020151</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030206</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146234-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-HQWYE795109OCT06</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>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COELIAC DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>1-2 CAPLETS AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugdosagetext>2-3</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIBRAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146235-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-000886</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>220 MG, QD</drugdosagetext>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146236-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR80880</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugbatchnumb>UNK.</drugbatchnumb>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>320 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146237-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR83108</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugbatchnumb>UNK.</drugbatchnumb>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5MG/100ML</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146238-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2010US03872</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>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHYSICAL DISABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146239-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2009CA13025</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED GASTRIC EMPTYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY TOXIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARACENTESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugdosagetext>350 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091014</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091014</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugdosagetext>50 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091023</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146240-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP42474</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>HYPOALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPROTEINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRIMARY AMYLOIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugdosagetext>150 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEPHROTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS NOS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146241-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA78594</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100216</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146242-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-US-EMD SERONO, INC.-7023007</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>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146243-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-US-EMD SERONO, INC.-7030353</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON BETA-1A</medicinalproduct>
        <drugindication>AMYOTROPHIC LATERAL SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100129</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146244-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-US-EMD SERONO, INC.-7028255</companynumb>
    <primarysource>
      <reportercountry>IRELAND</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>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040914</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146245-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-US-EMD SERONO, INC.-7021220</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO POSITIONAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146246-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-US-EMD SERONO, INC.-7030003</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091207</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146247-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-US-EMD SERONO, INC.-7000866</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>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</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>MENSTRUATION DELAYED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100316</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100324</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146248-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-US-EMD SERONO, INC.-7030343</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>INJECTION SITE INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugbatchnumb>Y15A7820</drugbatchnumb>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146249-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-EISAI INC.-E7389-01070-CLI-US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>100</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>E7389 (BOLD)</medicinalproduct>
        <drugauthorizationnumb>201532</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101123</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101123</drugenddate>
        <drugtreatmentduration>41</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHEST PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROBAXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugindication>VOMITING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RASH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
        <drugindication>VOMITING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILK OF MAGNESIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILK OF MAGNESIA</medicinalproduct>
        <drugindication>VOMITING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RASH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>RASH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTRISONE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>RASH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101117</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146250-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-001488</companynumb>
    <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>DRY SKIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FINACEA</medicinalproduct>
        <drugauthorizationnumb>021470</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146251-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0689497-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.24</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOSPADIAS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TALIPES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146252-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2010-33255</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</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>20090317</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146253-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2010-42083</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>TRACLEER</medicinalproduct>
        <drugbatchnumb>EP072P0102</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146254-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2010-41008</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BRAIN OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRANIOTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMATOMA</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>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTAVIS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CHANNEL BLOCKERS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146255-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2010-41072</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>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>EP071P0103</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146256-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2010-41396</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>DP026P0102</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146257-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2010-42095</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>EP073P0103</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TADALAFIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146258-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2010-42072</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>TRACLEER</medicinalproduct>
        <drugbatchnumb>EP073P0103</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101125</drugenddate>
        <drugtreatmentduration>206</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146259-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2010-42056</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</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>20100305</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146260-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2010-42082</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>TRACLEER</medicinalproduct>
        <drugbatchnumb>EP072P0102</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080409</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CHANNEL BLOCKERS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146261-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2010-42062</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>TRACLEER</medicinalproduct>
        <drugbatchnumb>DP026P0102</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146262-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2010-42111</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>TRACLEER</medicinalproduct>
        <drugbatchnumb>EP073P0103</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101126</drugenddate>
        <drugtreatmentduration>1362</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146263-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2010-40753</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>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILOPROST INHALATION SOLUTION 20UG US</medicinalproduct>
        <drugbatchnumb>01068A</drugbatchnumb>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>20 ?G, UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100804</drugenddate>
        <drugtreatmentduration>415</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146264-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-CELGENEUS-062-50794-10112856</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PHLEBOTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDAZA</medicinalproduct>
        <drugauthorizationnumb>050794</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146265-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ACTELION-A-CH2010-42309</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146266-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ACTELION-A-CH2010-42042</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPIDURAL ANAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE STRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET TRANSFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, OD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, OD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSTAGLANDIN I2</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOBUTAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146267-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ACTELION-A-CH2010-42037</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET UNKNOWN  EU MG</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146268-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ACTELION-A-CH2010-38916</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 62.5 MG EU</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>93.75 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100722</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 62.5 MG EU</medicinalproduct>
        <drugbatchnumb>8P075A0303</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100721</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 62.5 MG EU</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPIKLON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146269-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ACTELION-A-CH2010-42189</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BERAPROST SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146270-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ACTELION-A-CH2010-42052</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>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIGHT VENTRICULAR FAILURE</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BERAPROST SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL CITRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146271-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ACTELION-A-CH2010-41552</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 62.5 MG JPN</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060704</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 62.5 MG JPN</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050826</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 62.5 MG JPN</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>31.25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BERAPROST SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146272-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ACTELION-A-CH2010-42103</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>32 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146273-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-001556</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>100</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugbatchnumb>213330H</drugbatchnumb>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>440 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN [INSULIN]</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNCODEABLE ^UNCLASSIFIABLE^</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANALGESICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146274-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-001572</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SOMNAMBULISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugdosagetext>DAILY DOSE 1320 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOOTHACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALCOHOL [ETHANOL]</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101109</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146277-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-US-EMD SERONO, INC.-7030357</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146278-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-US-EMD SERONO, INC.-7030346</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugbatchnumb>Y16A7750</drugbatchnumb>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugbatchnumb>Y16A7750</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146279-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-US-EMD SERONO, INC.-7030350</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146280-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA072442</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>CARCINOID SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146281-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7030385</companynumb>
    <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>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101027</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146282-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-SANOFI-AVENTIS-2010SA072510</companynumb>
    <primarysource>
      <reportercountry>INDIA</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>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCOHERENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG ABUSE</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugdosagetext>DOSE INCREASED TO 60 MG/DAY OVER THE NEXT 6 MONTHS.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugdosagetext>DOSE INCREASED TO 60 MG/DAY OVER THE NEXT 6 MONTHS.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146283-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010005033</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1021465</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
        <drugtreatmentduration>322</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146284-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU436540</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BIOPSY BONE MARROW ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>480 A?G, UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROID NOS</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090102</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146285-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU424976</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APLASTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW RETICULIN FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>9 A?G/KG, QWK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100715</drugenddate>
        <drugtreatmentduration>431</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100607</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146286-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HK-AMGEN-US430535</companynumb>
    <primarysource>
      <reportercountry>HONG KONG</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB IMMOBILISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETACIN</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146287-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-10P-087-0663593-00</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100415</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100513</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100408</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN POTASSIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100520</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN POTASSIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN POTASSIUM</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100313</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugindication>ANTIFUNGAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100402</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPHERICAL CARBONACEOUS ADSORBENT</medicinalproduct>
        <drugdosagetext>6 GRAM</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100319</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM RISEDRONATE HYDRATE</medicinalproduct>
        <drugdosagetext>17.5MG/W</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>15MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFACALCIDOL</medicinalproduct>
        <drugdosagetext>1 MICROGRAM</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugdosagetext>10MG DAILY</drugdosagetext>
        <drugindication>GASTRITIS PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100311</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIFIDOBACTERIUM</medicinalproduct>
        <drugdosagetext>2 G</drugdosagetext>
        <drugindication>ENTEROCOLITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100325</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIFIDOBACTERIUM</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBAMIPIDE</medicinalproduct>
        <drugindication>GASTRITIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANEXAMIC ACID</medicinalproduct>
        <drugdosagetext>750 MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100325</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID/CALCIUM PANTOTHENATE</medicinalproduct>
        <drugdosagetext>600MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100325</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETIZOLAM</medicinalproduct>
        <drugdosagetext>0.5MG DAILY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146288-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2010SA073263</companynumb>
    <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>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN CR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021774</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146289-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-A03200903688</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>
      <patientweight>73.48</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONCUSSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST-TRAUMATIC AMNESTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN CR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021774</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN CR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021774</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugdosagetext>DOSE TEXT: TAKES DOSES OF 5MG OR LESS AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugdosagetext>DOSE TEXT: TAKES DOSES OF 7 TO 8 MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>20 MG ALTERNATING WITH 40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLGARD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AS DIRECTED (4-5 TIMES A DAY)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>0.25 TO  0.5</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146290-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-US-EMD SERONO, INC.-7029983</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRISOMET</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100318</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146291-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AMGEN-FRASP2010006888</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, FREQUENCY UNSPECIFIED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE</medicinalproduct>
        <drugdosagetext>12.5 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146292-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010001337</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL SKIN INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</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>20070604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101013</drugenddate>
        <drugtreatmentduration>1228</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1018841</drugbatchnumb>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NABUMETONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146293-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-EISAI INC.-E7389-01068-CLI-US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64</patientweight>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>E7389 (BOLD)</medicinalproduct>
        <drugauthorizationnumb>201532</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100623</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERLOTINIB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100624</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146294-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA-2010-0056445</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>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022272</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146295-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13281BP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146296-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13207BP</companynumb>
    <primarysource>
      <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>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>001697</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>001697</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146297-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13204BP</companynumb>
    <primarysource>
      <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>PRADAXA</medicinalproduct>
        <drugbatchnumb>001452</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugdosagetext>0.4 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM A-D</medicinalproduct>
        <drugdosagetext>2 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AGRYLIN</medicinalproduct>
        <drugdosagetext>0.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHROID</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTAQ</medicinalproduct>
        <drugdosagetext>400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146298-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-12472NB</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BI-SIFROL TABLETS</medicinalproduct>
        <drugbatchnumb>NR</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugdosagetext>4 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMTAN</medicinalproduct>
        <drugdosagetext>300 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MADOPAR</medicinalproduct>
        <drugdosagetext>300 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERMAX</medicinalproduct>
        <drugdosagetext>750 MCG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091125</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146299-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13205BP</companynumb>
    <primarysource>
      <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>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101115</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>7146300-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13209BP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146301-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13334BP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146302-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101120</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13125BP</companynumb>
    <primarysource>
      <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 MOTILITY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021530</drugauthorizationnumb>
        <drugdosagetext>15 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TENDON RUPTURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
        <drugindication>BACK INJURY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BC POWDER</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146303-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13124BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TOOTH LOSS</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>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146304-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13194BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EXPRESSIVE LANGUAGE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020884</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TRANSIENT ISCHAEMIC ATTACK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146305-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13202BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</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>20101118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIKOSYN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146306-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13330BP</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</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>7146307-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13192BP</companynumb>
    <primarysource>
      <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>COMBIVENT</medicinalproduct>
        <drugbatchnumb>065530A</drugbatchnumb>
        <drugauthorizationnumb>020291</drugauthorizationnumb>
        <drugdosagetext>8 PUF</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugdosagetext>360 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CATAPRES</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FLUID RETENTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD POTASSIUM DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146308-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BAXTER-2010BH028111</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>CARDIORENAL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHYSIOSOL IN PLASTIC CONTAINER</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHYSIOSOL IN PLASTIC CONTAINER</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHYSIOSOL IN PLASTIC CONTAINER</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>CARDIORENAL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146309-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101201026</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.84</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugauthorizationnumb>021999</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AFFECTIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AFFECTIVE DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146310-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101200580</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDROCAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INHIBACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASAPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146311-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101200978</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APPENDICITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>ORMKA84104</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>ORMKA84104</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>ORMKA84104</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESALAMINE</medicinalproduct>
        <drugdosagetext>4 TABS DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146312-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20101200845</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.11</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146313-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20101202663</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>INVEGA</medicinalproduct>
        <drugauthorizationnumb>021999</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146314-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA-2010-0046978</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022272</drugauthorizationnumb>
        <drugdosagetext>80 MG, SINGLE</drugdosagetext>
        <drugindication>SPINAL CORD INJURY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100820</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146315-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2010163778</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>20 MG, 1X/DAY AT NIGHT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE</medicinalproduct>
        <drugdosagetext>100 UG, 1X/DAY IN THE MORNING</drugdosagetext>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146316-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010163902</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>PLEURITIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOFT TISSUE INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYBREL</medicinalproduct>
        <drugauthorizationnumb>021864</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090130</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146317-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010158848</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>SUBILEUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101126</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146318-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2010SE57805</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEILAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146319-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAXTER-2010BH025925</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>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL PD-2 W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL PD-2 W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146320-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-GENZYME-POMP-1001214</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAL CAPACITY DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYOZYME</medicinalproduct>
        <drugindication>GLYCOGEN STORAGE DISEASE TYPE II</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146321-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENZYME-MOZO-1000438</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>ACUTE GRAFT VERSUS HOST DISEASE IN LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOOCCLUSIVE LIVER DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOZOBIL</medicinalproduct>
        <drugbatchnumb>10-001372</drugbatchnumb>
        <drugauthorizationnumb>022311</drugauthorizationnumb>
        <drugdosagetext>4 MG, ONCE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101008</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDARABINE PHOSPHATE</medicinalproduct>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIOTEPA</medicinalproduct>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146322-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GENZYME-THYM-1002109</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>ACUTE HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS ASSOCIATED LYMPHOPROLIFERATIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STENOTROPHOMONAS SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>3.75 MG/KG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>APLASTIC ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100919</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugdosagetext>500 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101027</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100922</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>APLASTIC ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101031</drugenddate>
        <drugtreatmentduration>175</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE SODIUM SUCCINATE</medicinalproduct>
        <drugdosagetext>125 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100919</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100919</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100919</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACICLOVIR</medicinalproduct>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146323-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-EISAI INC.-E2020-08063-SPO-US</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 FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugauthorizationnumb>020690</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146324-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAXTER-2010BH029412</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146325-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2010IT13386</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS BULLOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BICALUTAMIDE</medicinalproduct>
        <drugauthorizationnumb>078575</drugauthorizationnumb>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
        <drugtreatmentduration>305</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146326-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2010164501</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>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>FASCIITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>1095</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146327-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161567</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>020151</drugauthorizationnumb>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146328-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PFIZER INC-2010162728</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>REVATIO</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146329-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-PFIZER INC-2010162626</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHUNT OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOSTINEX</medicinalproduct>
        <drugauthorizationnumb>020664</drugauthorizationnumb>
        <drugdosagetext>0.25 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LACTATION INHIBITION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146330-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SK-PFIZER INC-2010164538</companynumb>
    <primarysource>
      <reportercountry>SLOVAKIA (Slovak Republic)</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SILDENAFIL CITRATE</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>3X/WEEK</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146331-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161063</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAIR TEXTURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOURETTE'S DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101104</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugdosagetext>200 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>80 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugdosagetext>20 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugdosagetext>2 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>100 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>300 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>2 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146332-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-PFIZER INC-2010160981</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>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>150 MG + 75 MG + 150 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101023</drugenddate>
        <drugtreatmentduration>450</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146333-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010159868</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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>75 MG, A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146334-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2010161072</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.15</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL ALCOHOL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugauthorizationnumb>020151</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAMPRAL EC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>ALCOHOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
        <drugtreatmentduration>122</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THIAMINE</medicinalproduct>
        <drugdosagetext>200 MG DAILY</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VITAMIN B</medicinalproduct>
        <drugdosagetext>1 DF, 2X/DAY</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146335-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-001772</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>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>440 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNCODEABLE ^UNCLASSIFIABLE^</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146336-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-TEVA-258321ISR</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL ALCOHOL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugauthorizationnumb>070233</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACAMPROSATE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THIAMINE, VITAMIN B SUBSTANCES</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VITAMIN B</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146337-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-TEVA-258599ISR</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>076119</drugauthorizationnumb>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101031</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146338-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-TEVA-258365GER</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>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITROFURANTOIN</medicinalproduct>
        <drugauthorizationnumb>073652</drugauthorizationnumb>
        <drugdosagetext>100MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID 100</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN W/HYDROCHLOROTHIAZIDE (ATACAND PLUS 16/12,5 MG)</medicinalproduct>
        <drugdosagetext>CANDESARTAN CILEXETIL 16 MG + HYDROCHLOROTHIAZIDE 12,5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146339-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006898</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>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>572.67 A?G, UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
        <drugtreatmentduration>141</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND HYDROCODONE BITARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>88 A?G, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146340-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-TEVA-258303ISR</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugauthorizationnumb>070152</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUETIAPINE FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUETIAPINE FUMARATE</medicinalproduct>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146341-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-JNJFOC-20101105368</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146342-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010007580</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>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146343-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010007069</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>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE MACULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1011870</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146344-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-PFIZER INC-2010164325</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</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>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIITH NERVE PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146345-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010162443</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.699</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FINE MOTOR DELAY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugdosagetext>100 MG, 1X/DAY AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>20 MG, 2X/DAY</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>10 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
        <drugdosagetext>2 L, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugdosagetext>200 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>UNK, 3X-5X/DAY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
        <drugdosagetext>2 PUFFS 2X/DAILY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>0.5 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146346-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101204</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160308</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>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugauthorizationnumb>018972</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146347-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010164118</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOVIAZ</medicinalproduct>
        <drugauthorizationnumb>022030</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTONIC BLADDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELMIRON</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYTRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORAMPHENICOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146348-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0679235-00</companynumb>
    <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>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100823</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN</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>ALLEGRA</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>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHERATUSSIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</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>2</drugcharacterization>
        <medicinalproduct>CYCLOPENZIPRINE</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>GLUCATROL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INNOPRAN</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>LASIX</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>VITAMINS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146349-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100927</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA-2010-0046520</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>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYCHONDRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRACHEOSTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146350-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-BAXTER-2010BH028272</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONEAL DIALYSIS COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>FIBRIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146351-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC.-2010-RO-01573RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugauthorizationnumb>076832</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugauthorizationnumb>076832</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146352-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC.-2010-RO-01572RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK COMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMIPRAMINE PAMOATE</medicinalproduct>
        <drugauthorizationnumb>091099</drugauthorizationnumb>
        <drugdosagetext>6000 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146353-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-PFIZER INC-2010165560</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
        <drugauthorizationnumb>022473</drugauthorizationnumb>
        <drugdosagetext>10 MG, 3X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101124</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146354-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2010157822</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</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>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>80 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146355-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-CEPHALON-2010006333</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MODAFINIL</medicinalproduct>
        <drugauthorizationnumb>020717</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NARCOLEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070626</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYSLEE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070705</drugenddate>
        <drugtreatmentduration>151</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZALIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090129</drugenddate>
        <drugtreatmentduration>703</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOBAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070719</drugenddate>
        <drugtreatmentduration>123</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070702</drugenddate>
        <drugtreatmentduration>74</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERENACE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070702</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070719</drugenddate>
        <drugtreatmentduration>123</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070702</drugenddate>
        <drugtreatmentduration>618</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TSUMURA-YOKUKANSAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070626</drugenddate>
        <drugtreatmentduration>74</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146356-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101205</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-CEPHALON-2010006318</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOBULINS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TREANDA</medicinalproduct>
        <drugauthorizationnumb>022249</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101126</drugenddate>
        <drugtreatmentduration>71</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>09P004A5Q3</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101126</drugenddate>
        <drugtreatmentduration>71</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CILAZAPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
        <drugindication>HYPOGONADISM MALE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROGRADUMET</medicinalproduct>
        <drugindication>ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>GOUT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146357-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13333331</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>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPIDER VEIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
        <drugdosagetext>TWO MONTHS PRIOR TO THE REPORT THE PT. TOOK PRAVACHOL 80MG DAILY FOR THREE DAYS.</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELENIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146358-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-14806517</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>PRAVASTATINE TABS</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146359-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-14823876</companynumb>
    <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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
        <drugdosagetext>STARTED WITH 20 MG 3 MONTHS AGO AND DOSE WAS INCREASED TO 40 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146360-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-14857205</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>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
        <drugdosagetext>DURATION OF THERAPY: APPROX FOUR YEARS AGO.</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146361-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-14862916</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>
      <patientweight>92</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CINRYZE</medicinalproduct>
        <drugdosagetext>1 DF= 1000 UNITS; FORM=INJ</drugdosagetext>
        <drugindication>HEREDITARY ANGIOEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090708</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DANAZOL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090715</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENAZOPYRIDINE HCL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146362-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-14864060</companynumb>
    <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>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146363-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091120</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-14866420</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>INCREASED TENDENCY TO BRUISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146364-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-14869309</companynumb>
    <primarysource>
      <reportercountry>PUERTO RICO</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>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
        <drugdosagetext>DURATION OF THERAPY=2 MONTHS FOR 20MG,THEN DOSE VAULE INCREASED TO 40MG.</drugdosagetext>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146365-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-14870547</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146366-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-14876759</companynumb>
    <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>SUPRAVENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146367-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091228</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-14913883</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>
      <patientweight>86</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
        <drugdosagetext>INITIAL DOSE 20MG DAILY(FOR 15 YRS);FOR 5 YRS 40MG DAILY.</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146368-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091223</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-14914865</companynumb>
    <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>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146369-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-14921837</companynumb>
    <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>PARATHYROID DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
        <drugdosagetext>TABS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146370-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-14924708</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>1 DOSAGE FORM = 20MG A? TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>1DF=1/2TABLET</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLOW FE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146371-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-14928253</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>
      <patientweight>63</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091231</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANDROGEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146372-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-14951628</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>PRAVASTATIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146373-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-14954176</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>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146374-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-14963722</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146375-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100204</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-14965420</companynumb>
    <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>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146376-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100204</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-14965495</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146377-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100212</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-14975742</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>102</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLANTAR FASCIITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAVELLA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIMPAT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146378-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100412</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-14983134</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>71</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOSMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOTALOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COLD REMEDY</medicinalproduct>
        <drugbatchnumb>30578</drugbatchnumb>
        <drugdosagetext>GEL SWABS INITIATED A YR AGO</drugdosagetext>
        <drugindication>NASOPHARYNGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITRO-DUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SKELAXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146379-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100324</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-14984504</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>PRAVASTATIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146380-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100224</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-14992028</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146381-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100303</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15000193</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>57</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146382-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100415</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15002496</companynumb>
    <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 COUNTERFEIT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146383-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100304</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15003940</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146384-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100324</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15009533</companynumb>
    <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>PRAVASTATIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146385-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100312</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15019227</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
        <drugdosagetext>STARTED WITH 40 MG, THEN INCREASED TO 80MG AND AGAIN DECREASED TO 40 MG.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146386-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100328</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15028186</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</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTASIS</medicinalproduct>
        <drugdosagetext>RESTASIS EYE DROPS</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146387-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100329</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15042609</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>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146388-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100408</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15049588</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>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTAQ</medicinalproduct>
        <drugbatchnumb>AE02</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146389-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100519</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15054083</companynumb>
    <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>PRAVASTATIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146390-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100413</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15060361</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>86</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugindication>NASOPHARYNGITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146391-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100412</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15061914</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>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146392-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100412</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15061955</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146393-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100421</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15064629</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>104</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
        <drugdosagetext>1 DF = 40MG IN THE MORNING + ADDITIONAL 2 TABLETS IN AFTERNOON ON 15-APR-2010.THERAPY ONGOING.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146394-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100429</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15086119</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</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>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146395-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100611</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15086341</companynumb>
    <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>PRAVASTATIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
        <drugdosagetext>TABLET.</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146396-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100503</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15087927</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>FACIAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
        <drugdosagetext>DURATION OF THERAPY:3-4 MONTHS.</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146397-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100505</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15093644</companynumb>
    <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>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
        <drugdosagetext>STARTED 1 WEEK AGO.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146398-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100506</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15095516</companynumb>
    <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>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146399-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100507</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15095821</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>86</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
        <drugindication>CARDIAC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugindication>LUNG INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146400-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100510</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15098304</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>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146401-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100511</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15103088</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>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugauthorizationnumb>020357</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIABETA</medicinalproduct>
        <drugdosagetext>TABS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEBIVOLOL HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146402-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100512</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15103518</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>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146403-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100511</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15106511</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>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOPID</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146404-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100521</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15118771</companynumb>
    <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>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146405-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15119803</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>113</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugbatchnumb>0C60414A</drugbatchnumb>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
        <drugdosagetext>80MG A? TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCARDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUFFERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QVAR 40</medicinalproduct>
        <drugdosagetext>QVAR 80 SPRAY MDI</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146406-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100524</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15121874</companynumb>
    <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>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146407-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100603</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15135320</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146408-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100607</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15139066</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>PRODUCT COLOUR ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146409-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100623</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15163389</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>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146410-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100629</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15171127</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>TINEA INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146411-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100629</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15171721</companynumb>
    <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>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146412-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100804</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15174873</companynumb>
    <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>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146413-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15185663</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGEUSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
        <drugdosagetext>3 MONTHS AGO</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146414-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100721</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15203268</companynumb>
    <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>PRAVASTATIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>REDUCED TO 20MG, ON 01-JUL-2010 WAS TAKING 10 MG, HAD BEEN CUTTING 20 MG TABS IN HALF.</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146415-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100721</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15204787</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>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEVACOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146416-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100728</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15215981</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>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146417-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100728</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15216039</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>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146418-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100802</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15216765</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>121</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TESTICULAR SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100728</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146419-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100805</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15231889</companynumb>
    <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>PRAVASTATIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146420-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100923</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15236052</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
        <drugdosagetext>1 TABS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIXED HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100726</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146421-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100916</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15247596</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>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONGLYZA</medicinalproduct>
        <drugauthorizationnumb>022350</drugauthorizationnumb>
        <drugdosagetext>ONGLYZA TABS 2.5 MG FOR 8 WEEKS PREVIOUSLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugauthorizationnumb>073318</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugauthorizationnumb>020357</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STARLIX</medicinalproduct>
        <drugdosagetext>120 MG TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAVIK</medicinalproduct>
        <drugdosagetext>4 MG BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146422-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100819</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15247984</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>79</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146423-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100823</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15250616</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>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146424-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15261365</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>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146425-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100831</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15262678</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>83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
        <drugdosagetext>40 MG Q PM</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146426-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100901</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15266000</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
        <drugdosagetext>DOSE TAKEN FOR 4 YEARS,NEW BATCH ON 08AUG2010.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146427-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100902</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15269558</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146428-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100902</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15270457</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>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugdosagetext>INITIAL DOSE 500MG ON APROX JUL2009- APROXJAN2010; 1000 MG FROM JAN-2010-ONGOING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIGRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERGOCALCIFEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM-SANDOZ</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146429-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100902</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15270978</companynumb>
    <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>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146430-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100903</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15272040</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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146431-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100910</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15281330</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146432-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15300387</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
        <drugdosagetext>STARTED APPROXIMATETELY AT 01SEP2010</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146433-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15301617</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIPIDS INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146434-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100929</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15311392</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146435-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15313299</companynumb>
    <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>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
        <drugauthorizationnumb>021178</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146436-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15319577</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>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146437-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15335292</companynumb>
    <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>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146438-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15343411</companynumb>
    <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>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146439-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA76351</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARACENTESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>10 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROENDOCRINE TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091203</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146440-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010ES80476</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAFIRO</medicinalproduct>
        <drugauthorizationnumb>021990</drugauthorizationnumb>
        <drugdosagetext>1 DF/DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101024</drugenddate>
        <drugtreatmentduration>711</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
        <drugdosagetext>2.5 MG/DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugdosagetext>50 MG/ DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>10MG/DAY</drugdosagetext>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINTROM</medicinalproduct>
        <drugdosagetext>2.28 MG/ 7 TIMES PER DAY</drugdosagetext>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146441-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US80786</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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>160 MG, QD</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101124</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146442-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US81267</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1500 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101107</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146443-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2009US14767</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHELATION THERAPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1000 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONGENITAL APLASTIC ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1000 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146444-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP82363</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>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS ENTEROCOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ICL670A ICL+DISTAB</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON OVERLOAD</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090731</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ICL670A ICL+DISTAB</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>625 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090903</drugenddate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESFERAL</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090701</drugenddate>
        <drugtreatmentduration>54</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090804</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146445-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2009CA24394</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IRON INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>750 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON OVERLOAD</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090705</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>750 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090816</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>250 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091110</drugstartdate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>750 MG DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1000 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugdosagetext>35 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugdosagetext>150 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REACTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-CORTEF</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146446-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7030384</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTRAST MEDIA ALLERGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL MENINGEAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080616</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146447-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010TW52421</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA HEPATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL STROMAL TUMOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146448-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US60047</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>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090930</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146449-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US82572</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100112</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146450-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010MX46259</companynumb>
    <primarysource>
      <reportercountry>MEXICO</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEXUALLY TRANSMITTED DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugdosagetext>80/12.5 MG, PER DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
        <drugtreatmentduration>215</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugdosagetext>160/12.5 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146451-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA45800</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WALKING AID USER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090507</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100730</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146452-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-10P-020-0688754-00</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAL FISSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ZINC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>INDUCTION DOSE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>INDUCTION DOSE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANAL FISSURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD ZINC ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146453-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ABBOTT-10P-114-0688505-00</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>39</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DERMATOMYOSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXI</medicinalproduct>
        <drugdosagetext>1 UNIT TWICE A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITROMYCINE COATED TABLETS (2-WATER)</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SKIN INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
        <drugdosagetext>1/2 TABLETS ONCE WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugdosagetext>1/2 TABLET TWICE A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DERMATOMYOSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugdosagetext>1 UNIT  TWICE DAILY AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugindication>DERMATOMYOSITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOL MSR</medicinalproduct>
        <drugdosagetext>1 UNIT TWICE A DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOL MSR</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>1 1/2 TABLET BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DERMATOMYOSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146454-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0688571-00</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICAL HYSTERECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPRON</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020011</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146455-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0688580-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENDOMETRIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTRICHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYSTERECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENOPAUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY SLEEP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPRON</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020011</drugauthorizationnumb>
        <drugindication>ENDOMETRIOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146456-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-10P-167-0689528-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070415</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070415</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULPHASALAZINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070415</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146457-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ABBOTT-10P-013-0672334-00</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOPARESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANIDIP</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>SERTRALINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</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>7146458-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NAPPMUNDI-USA-2010-0053123</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>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022272</drugauthorizationnumb>
        <drugdosagetext>30 MG, BID</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146459-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010007113</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURILEMMOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1023549</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146460-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-CEPHALON-2010006326</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TREANDA</medicinalproduct>
        <drugauthorizationnumb>022249</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100917</drugenddate>
        <drugtreatmentduration>38</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100917</drugenddate>
        <drugtreatmentduration>38</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146461-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US75125</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SERUM FERRITIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1250MG DAILY</drugdosagetext>
        <drugindication>IRON OVERLOAD</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100916</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146462-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US77544</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1500 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146463-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2008US37093</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATOBILIARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BREAST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1000 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON OVERLOAD</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080915</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APROXAL</medicinalproduct>
        <drugdosagetext>150 MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>10 MG, QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>20 MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>37.5/5.25</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146464-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010TW65382</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1250 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THALASSAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146465-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010PE16230</companynumb>
    <primarysource>
      <reportercountry>PERU</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED ALISKIREN ALI+TAB+CF</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>CODE NOT BROKEN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100924</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED ENALAPRIL COMP-ENA+</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>CODE NOT BROKEN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100924</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED NO TREATMENT RECEIVED NOMED</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>CODE NOT BROKEN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100924</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALISKIREN</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMPARATOR ENALAPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100824</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPHENIRAMINE</medicinalproduct>
        <drugindication>NASOPHARYNGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugindication>NASOPHARYNGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTROMETHORPHAN HYDROBROMIDE</medicinalproduct>
        <drugindication>COUGH</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146466-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US60145</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPEUTICS NOS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146467-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2009US19043</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146468-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2006US02698</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146469-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010148313</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>47.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL COLD AND SINUS</medicinalproduct>
        <drugauthorizationnumb>019771</drugauthorizationnumb>
        <drugdosagetext>1 LIQUI-GEL 1 TIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101025</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146470-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-PFIZER INC-2010156259</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENEFIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146471-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2010152829</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHINADVIL</medicinalproduct>
        <drugauthorizationnumb>019771</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101030</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AERIUS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRURITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146472-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-CCAZA-10101391</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66.738</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZACITIDINE</medicinalproduct>
        <drugauthorizationnumb>050794</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100809</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZACITIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101004</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL PM</medicinalproduct>
        <drugdosagetext>500MG/25MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE CHONDROITIN</medicinalproduct>
        <drugdosagetext>500MG-400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GINKGO BILOBA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>120-180MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101013</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYSINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100803</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100909</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100218</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100728</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DECREASED APPETITE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON OVERLOAD</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100928</drugenddate>
        <drugtreatmentduration>97</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCOSAHEXANOIC ACID</medicinalproduct>
        <drugdosagetext>120/180 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS</medicinalproduct>
        <drugdosagetext>2 UNITS</drugdosagetext>
        <drugadministrationroute>051</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN/DPHYRAM</medicinalproduct>
        <drugdosagetext>500/25MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100728</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100714</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100714</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100714</drugenddate>
        <drugtreatmentduration>176</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DRONABINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>APPETITE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEXOFENADINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHINITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100714</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEFERASIROX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON OVERLOAD</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100928</drugenddate>
        <drugtreatmentduration>97</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146473-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2010-42139</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVERSION</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>20101105</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146474-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CEPHALON-2010005958</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>115</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TREANDA</medicinalproduct>
        <drugbatchnumb>18898/1889</drugbatchnumb>
        <drugauthorizationnumb>022249</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101029</drugenddate>
        <drugtreatmentduration>143</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BORTEZOMIB</medicinalproduct>
        <drugbatchnumb>100731</drugbatchnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101105</drugenddate>
        <drugtreatmentduration>150</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101029</drugenddate>
        <drugtreatmentduration>143</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101103</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146475-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH021452</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>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146476-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CEPHALON-2010006346</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CRANIAL NERVE PALSIES MULTIPLE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TREANDA</medicinalproduct>
        <drugauthorizationnumb>022249</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146477-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH022308</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>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146478-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH027611</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>92</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERAHEME</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTEIN SUPPLEMENTS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENSIPAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146479-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJCH-2010027738</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugauthorizationnumb>020150</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>TEXT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146480-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH029261</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100923</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146481-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010006612</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BIOPSY BONE MARROW ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IVIGLOB-EX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146482-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH029287</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146485-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH029297</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>5B5163</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100512</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146486-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NAPPMUNDI-USA-2010-0047287</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>CHOKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INADEQUATE ANALGESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED UPPER AIRWAY SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022272</drugauthorizationnumb>
        <drugdosagetext>60 MG, TID</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100908</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146487-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-725515</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>45.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>DOSAGE FOR: INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100624</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>LAST DOSE PRIOR TO SAE ON 05 AUGUST 2010. DRUG PERMANENTLY DISCONTINUED</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100805</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMOZOLOMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100624</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMOZOLOMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMOZOLOMIDE</medicinalproduct>
        <drugdosagetext>LAST DOSE PRIOR TO SAE ON 05 AUGUST 2010. DRUG PERMANENTLY DISCONTINUED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100805</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETIZOLAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BROTIZOLAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TROPISETRON HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146488-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13176BP</companynumb>
    <primarysource>
      <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>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101121</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146489-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13221BP</companynumb>
    <primarysource>
      <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>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</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>20101119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146490-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13222BP</companynumb>
    <primarysource>
      <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>OESOPHAGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>001452</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101122</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146491-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-703364</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>BACK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2A</medicinalproduct>
        <drugdosagetext>FORM: PRE-FILLED SYRINGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2A</medicinalproduct>
        <drugdosagetext>IN WEEK 24</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVARIN</medicinalproduct>
        <drugdosagetext>DIVIDED DOSES.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146492-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13355BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL 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>PULMONARY EMBOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICYCLOMINE</medicinalproduct>
        <drugindication>ABDOMINAL PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT B</medicinalproduct>
        <drugindication>VITAMIN B COMPLEX DEFICIENCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>3 HEART MEDICATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146493-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13322BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</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>20101116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STALEVO 100</medicinalproduct>
        <drugdosagetext>125 MG</drugdosagetext>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REQUIP XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITONIN SALMON</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRASE MT20</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBETASOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOCINONIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D + CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146494-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13350BP</companynumb>
    <primarysource>
      <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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>150 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTIN</medicinalproduct>
        <drugindication>BLADDER DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANXIETY MEDICINE</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugindication>MUSCULOSKELETAL CHEST PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146495-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13400BP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</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>20101121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146496-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13210BP</companynumb>
    <primarysource>
      <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>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</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>20101122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146497-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13402BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146498-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13356BP</companynumb>
    <primarysource>
      <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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</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>20101119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146499-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13394BP</companynumb>
    <primarysource>
      <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>GINGIVAL 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>20101119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVALIDE</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146500-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13405BP</companynumb>
    <primarysource>
      <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>BLOOD GLUCOSE ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146501-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-715261</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS ENTEROPATHIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSTHYMIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA NODOSUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS EROSIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIXED CONNECTIVE TISSUE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMOCHROMIC NORMOCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHERATUSSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GUAIFENEX DM</medicinalproduct>
        <drugdosagetext>GUAIFENEX</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA D 24 HOUR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146502-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-744260</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</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>ACTEMRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146503-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-746446</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>CHOLANGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PORTAL VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090307</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090404</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090502</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091023</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146504-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA-2010-0056037</companynumb>
    <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 AND/OR ORAL CAVITY CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>WAD21</drugbatchnumb>
        <drugauthorizationnumb>022272</drugauthorizationnumb>
        <drugdosagetext>80 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>W8Y91</drugbatchnumb>
        <drugauthorizationnumb>022272</drugauthorizationnumb>
        <drugdosagetext>40 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146505-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2010160360</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IXPRIM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOLIPRANE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>NEURALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146506-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-JP-WYE-H18273810</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>49</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugdosagetext>6 MG, 1X/WK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>1 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GASTER</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NATRIX</medicinalproduct>
        <drugdosagetext>1 DF, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugdosagetext>50 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>1 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EURODIN</medicinalproduct>
        <drugdosagetext>1 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIN</medicinalproduct>
        <drugdosagetext>5 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIAMIN</medicinalproduct>
        <drugdosagetext>5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101019</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146507-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160485</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>32.88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN-125</medicinalproduct>
        <drugauthorizationnumb>008762</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146508-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2008022040</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugbatchnumb>A0235</drugbatchnumb>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, 1X/DAY</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>1 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>1 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTYNIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLADDER DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146509-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-PFIZER INC-2010162200</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugdosagetext>600 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100819</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACICLOVIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146510-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2010154668</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</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>1</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>20 MG, 3X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>PENTAERYTHRITOL TETRANITRATE</medicinalproduct>
        <drugdosagetext>80 MG, 3X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146511-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2010159041</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>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINIDIAB</medicinalproduct>
        <drugauthorizationnumb>017783</drugauthorizationnumb>
        <drugdosagetext>1/2 TABLET OF 5MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD GLUCOSE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146512-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-PFIZER INC-2010161184</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>METASTATIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146513-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010157496</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>61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUNITINIB MALATE</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146514-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010007797</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BONE MARROW DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNOGLOBULINS</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146515-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028607</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>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146516-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BAXTER-2010BH020992</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UROSEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>POLYMYALGIA RHEUMATICA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>POLYMYALGIA RHEUMATICA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>VASCULITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOCORTICOIDS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146517-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-CELGENEUS-056-50794-09020799</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PHOSPHORUS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDAZA</medicinalproduct>
        <drugauthorizationnumb>050794</drugauthorizationnumb>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090130</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPECIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARDEGIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEO RECORMON</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANOCYTE 34</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHOSPHORUS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>FLUID REPLACEMENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146518-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010164154</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC ANEURYSM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TORISEL</medicinalproduct>
        <drugauthorizationnumb>022088</drugauthorizationnumb>
        <drugdosagetext>25 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146519-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2010146553</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146520-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100114</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010NZ81121</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146521-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GENENTECH-310347</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOROIDAL NEOVASCULARISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146523-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-GENENTECH-301049</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARTILAGE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAND DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1000 MG/ML, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090816</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101013</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARCOXIA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>90 MG, QAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE SULFATE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1.5 MG, QAM</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUTIROX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUTHYROX</medicinalproduct>
        <drugdosagetext>25 A?G, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146524-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HR-MYLANLABS-2010S1021875</companynumb>
    <primarysource>
      <reportercountry>CROATIA (local name: Hrvatska)</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>DEAFNESS NEUROSENSORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS ASEPTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VESTIBULAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>070045</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>070045</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSURIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSURIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN AND CLAVULANATE POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN AND CLAVULANATE POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSURIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSURIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146525-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GENENTECH-310348</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>SENSATION OF FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>0.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100104</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146526-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HR-MYLANLABS-2010S1021875</companynumb>
    <primarysource>
      <reportercountry>CROATIA (local name: Hrvatska)</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>DEAFNESS NEUROSENSORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS ASEPTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VESTIBULAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSURIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugauthorizationnumb>074023</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugauthorizationnumb>074023</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSURIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN AND CLAVULANATE POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN AND CLAVULANATE POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSURIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSURIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146527-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010AU81130</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>GLIVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146528-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-GENENTECH-310623</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>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>B6105B01</drugbatchnumb>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100508</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146529-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7030998</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 LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146530-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7024880</companynumb>
    <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>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NEURITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146531-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7019605</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>SUICIDAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101005</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146532-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7020428</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN ENLARGEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugindication>NARCOLEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
        <drugindication>MUSCLE RELAXANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
        <drugindication>GASTRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146533-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7012812</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</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>20100623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugindication>PSYCHIATRIC SYMPTOM</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>PSYCHIATRIC SYMPTOM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>EMBOLISM ARTERIAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146534-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101204</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010IN82635</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED INTRAABDOMINAL FLUID COLLECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG, UNK</drugdosagetext>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146535-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US59203</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1000 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SICKLE CELL ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146536-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010IN82557</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>GLIVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146537-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US82943</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>100 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCINEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAVATAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PILOCARPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COSOPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON SUPPLEMENTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146538-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US82610</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146539-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010US82671</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>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1000 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146540-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2010JP17339</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAROSMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINELL TTS (NCH)</medicinalproduct>
        <drugauthorizationnumb>020076</drugauthorizationnumb>
        <drugdosagetext>52.5 MG, QD</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100819</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINELL TTS (NCH)</medicinalproduct>
        <drugauthorizationnumb>020076</drugauthorizationnumb>
        <drugdosagetext>17.5 MG, QD</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146541-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2010US18469</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>81.633</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THERAFLU WARMING RELIEF SINUS + COLD (NCH)</medicinalproduct>
        <drugbatchnumb>2005153</drugbatchnumb>
        <drugdosagetext>1 CAPFUL, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFLUENZA LIKE ILLNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101201</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THERAFLU WARMING RELIEF SINUS + COLD (NCH)</medicinalproduct>
        <drugbatchnumb>2005153</drugbatchnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THERAFLU WARMING RELIEF SINUS + COLD (NCH)</medicinalproduct>
        <drugindication>UPPER RESPIRATORY TRACT CONGESTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>2 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146542-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2010US18593</companynumb>
    <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>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIVATE LABEL (NCH)</medicinalproduct>
        <drugauthorizationnumb>020076</drugauthorizationnumb>
        <drugdosagetext>14 MG, QD</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146543-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2010US18119</companynumb>
    <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>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEDRIN (MIGRAINE)</medicinalproduct>
        <drugdosagetext>4 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEDRIN (MIGRAINE)</medicinalproduct>
        <drugdosagetext>3 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEDRIN (MIGRAINE)</medicinalproduct>
        <drugdosagetext>2 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEDRIN (MIGRAINE)</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146544-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2010US15826</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>72.562</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF REPAIR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EX-LAX REG STR CHOCOLATED LAX PCS SEN (NCH)</medicinalproduct>
        <drugbatchnumb>10793</drugbatchnumb>
        <drugdosagetext>30 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101006</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EX-LAX REG STR CHOCOLATED LAX PCS SEN (NCH)</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146545-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MYLANLABS-2010S1021918</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.35</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL GROWTH RESTRICTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARUNAVIR ETHANOLATE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100218</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100218</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE + ZIDOVUDINE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100603</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugauthorizationnumb>078922</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100603</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146546-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-KDC433621</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LIP ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANITUMUMAB</medicinalproduct>
        <drugdosagetext>6 MG/KG, Q2WK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100804</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANITUMUMAB</medicinalproduct>
        <drugdosagetext>4.8 MG/KG, Q2WK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100913</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>200 MG, Q2WK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAKEPRON OD TABLETS 15</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAKEPRON OD TABLETS 15</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HICEE GRANULES 25%</medicinalproduct>
        <drugdosagetext>3 G, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>640 MG, Q2WK</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>3750 MG, Q2WK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM LEVOFOLINATE</medicinalproduct>
        <drugdosagetext>320 MG, Q2WK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM LEVOFOLINATE</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TSUMURA GOSHAJINKIGAN</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TSUMURA GOSHAJINKIGAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TSUMURA HOCHU EKKI-TO</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TSUMURA HOCHU EKKI-TO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TSUMURA SHAKUYAKUKANZOUTOU</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TSUMURA SHAKUYAKUKANZOUTOU</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVACT</medicinalproduct>
        <drugdosagetext>3 UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAKTAR</medicinalproduct>
        <drugdosagetext>.5 G, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODIOL</medicinalproduct>
        <drugdosagetext>3 UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugdosagetext>1.5 G, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUSO</medicinalproduct>
        <drugdosagetext>1.8 G, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TSUMURA HANGESHASHINTO</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TSUMURA HANGESHASHINTO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TSUMURA HANGESHASHINTO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAUZELIN</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAUZELIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAUZELIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHISTAMINES</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHISTAMINES</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROID NOS</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TSUMURA HOCHUUEKKITOU</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146547-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL437091</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE MALFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1021464</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100225</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146548-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-CELGENEUS-087-21880-10112963</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>34.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100916</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101015</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101027</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101117</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101117</drugenddate>
        <drugtreatmentduration>70</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NU-LOTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101117</drugenddate>
        <drugtreatmentduration>70</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101117</drugenddate>
        <drugtreatmentduration>70</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101117</drugenddate>
        <drugtreatmentduration>70</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEZATOL SR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101117</drugenddate>
        <drugtreatmentduration>70</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101103</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101117</drugenddate>
        <drugtreatmentduration>70</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101117</drugenddate>
        <drugtreatmentduration>70</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101117</drugenddate>
        <drugtreatmentduration>70</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101117</drugenddate>
        <drugtreatmentduration>62</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugdosagetext>2 UNITS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101117</drugenddate>
        <drugtreatmentduration>62</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100923</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101104</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146549-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-PFIZER INC-2010143130</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</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>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GROIN PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146550-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-US-WYE-H18038710</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHONDROCALCINOSIS PYROPHOSPHATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugbatchnumb>E4137</drugbatchnumb>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBIDOPA + LEVODOPA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>0.2 MG, AS NEEDED</drugdosagetext>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146551-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-US-WYE-H17364610</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.633</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FLUTTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>25 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146552-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-PFIZER INC-2010123788</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>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100706</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APIXABAN</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100706</drugenddate>
        <drugtreatmentduration>694</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APIXABAN</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100728</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>2 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100706</drugenddate>
        <drugtreatmentduration>694</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>2 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100729</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146553-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MYLANLABS-2010S1021950</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADACTYLY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL ANTICONVULSANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER DEVELOPMENTAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugauthorizationnumb>077254</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146554-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MYLANLABS-2010S1021953</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL ANTICONVULSANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEARNING DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL RETARDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER DEVELOPMENTAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TALIPES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugauthorizationnumb>077254</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146555-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100806</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0663113-00</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>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERY-TAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>062298</drugauthorizationnumb>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100726</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERY-TAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>062298</drugauthorizationnumb>
        <drugindication>TOOTH ABSCESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146556-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0683634-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.824</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERY-TAB 250MG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>062298</drugauthorizationnumb>
        <drugindication>RESPIRATORY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROBITUSSIN DM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THERAFLU</medicinalproduct>
        <drugdosagetext>1.5 PACK A DAY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146557-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0668508-00</companynumb>
    <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>ERY-TAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>062298</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146558-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100910</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0671024-00</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>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERY-TAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>062298</drugauthorizationnumb>
        <drugindication>ACNE</drugindication>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYVANSE</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>7146559-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-MYLANLABS-2010S1021947</companynumb>
    <primarysource>
      <reportercountry>POLAND</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugauthorizationnumb>075790</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRURITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146560-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10091970</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100811</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugdosagetext>1000 MCG/ML</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA S</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE AND ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>500MG-5MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM PLUS VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146561-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13844BP</companynumb>
    <primarysource>
      <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 INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>002005C,9D1002</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLERGY MEDICINE</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146562-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC.-2010-RO-01574RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS ASSOCIATED LYMPHOPROLIFERATIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>040054</drugauthorizationnumb>
        <drugindication>PULMONARY SARCOIDOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugauthorizationnumb>080352</drugauthorizationnumb>
        <drugindication>PULMONARY SARCOIDOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugauthorizationnumb>074069</drugauthorizationnumb>
        <drugindication>EVIDENCE BASED TREATMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVETIRACETAM</medicinalproduct>
        <drugauthorizationnumb>078042</drugauthorizationnumb>
        <drugindication>GRAND MAL CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM + SULFAMETHOXAZOLE</medicinalproduct>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146563-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PFIZER INC-2010162950</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>
      <reaction>
        <reactionmeddrapt>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugindication>HOT FLUSH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146564-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010127341</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
        <drugdosagetext>ONE DROP INTO BOTH EYES, ONCE DAILY, AT NIGHT</drugdosagetext>
        <drugindication>GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101029</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146565-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2010160146</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALATAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY IN THE EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARCOXIA</medicinalproduct>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAFALGAN CODEINE</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146566-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-10P-087-0678763-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEEDING DISORDER NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE FOR DATES BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT TACHYPNOEA OF THE NEWBORN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021906</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPZICOM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MENATETRENONE</medicinalproduct>
        <drugdosagetext>1 MILLILITER</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091113</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146567-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ABBOTT-10P-083-0687748-00</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ABLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPAFENONE HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>650 MG, FREQUENCY 2 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FLUTTER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPAFENONE HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146568-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0688575-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYSTERECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPRON DEPOT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020011</drugauthorizationnumb>
        <drugdosagetext>3 MONTH SHOT</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146569-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-10P-028-0679608-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>23.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMOCHROMIC NORMOCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>JOINT SWELLING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVETIRACETAM</medicinalproduct>
        <drugdosagetext>375 MG MORNING , 500 MG EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146570-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-ABBOTT-10P-129-0683285-00</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRACHIAL PLEXUS INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>3 DOSES OF 40 MG EVERY 2 WEEKS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100708</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugdosagetext>4-8 MG A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146571-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-10P-020-0667899-00</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>880269A03</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>880269A03</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>880269A03</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100709</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100820</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100820</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146572-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-09P-167-0566138-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>106</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KLEBSIELLA SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>TRANSIENT ISCHAEMIC ATTACK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRIDAMOLE</medicinalproduct>
        <drugindication>TRANSIENT ISCHAEMIC ATTACK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TRANSIENT ISCHAEMIC ATTACK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146573-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-10P-056-0688562-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL BELOW THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020593</drugauthorizationnumb>
        <drugindication>STATUS EPILEPTICUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFADIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIMIFON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYAMBUTOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIRILENE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
        <drugindication>LYMPH NODE TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
        <drugindication>PULMONARY TUBERCULOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
        <drugindication>MENINGITIS TUBERCULOUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRODILANTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101013</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDREA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPECIAFOLDINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146574-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0688687-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOESTRIN FE 1/20</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN ANTIBIOTIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146575-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GE-ABBOTT-10P-225-0683662-00</companynumb>
    <primarysource>
      <reportercountry>GEORGIA</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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT LOSS POOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MERIDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020632</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVERWEIGHT</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MERIDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020632</drugauthorizationnumb>
        <drugindication>OBESITY</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MERIDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020632</drugauthorizationnumb>
        <drugindication>BODY MASS INDEX</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146576-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0688372-00</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>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL HD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146577-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-10P-087-0666329-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>42.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100726</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100604</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100726</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100726</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100726</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 300MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100726</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100726</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>ADVERSE DRUG REACTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 10MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100318</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugindication>ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 5MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 400MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETODOLAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100726</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROID</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 40MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROID</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 20MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROID</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 10MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM HYDRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100726</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146578-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-10P-167-0689529-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070717</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULPHASALAZINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080215</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146579-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-09P-163-0600778-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOGENITAL WARTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSON'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>T-LYMPHOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021906</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146580-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0688589-00</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE PROLAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPRON DEPOT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020011</drugauthorizationnumb>
        <drugindication>ENDOMETRIOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADBACK THERAPY</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146581-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MYLANLABS-2010S1021918</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.35</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL GROWTH RESTRICTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARUNAVIR ETHANOLATE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100218</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100218</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE + ZIDOVUDINE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100603</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugauthorizationnumb>078922</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100603</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146582-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-10P-028-0667324-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GROWTH RETARDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100312</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1 TABLET EVERY 4 HOURS AS NEEDED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146583-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ABBOTT-10P-008-0688233-00</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINIPRESS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146584-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-10P-028-0680143-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBELLAR ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION VENTRICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018082</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AFFECTIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018082</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018082</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMANTADINE HCL</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>DOCUSATE SODIUM</medicinalproduct>
        <drugdosagetext>100MG (25ML) TWICE A DAY (IN MORNING AND AT NIGHT)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugdosagetext>20G (30ML) ONCE A DAY AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>AM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugdosagetext>150MG (2.5ML) TWICE A DAY (AM AND DINNER)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIA WITH CASCARA</medicinalproduct>
        <drugdosagetext>66/33% DIE AT NIGHT AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDES</medicinalproduct>
        <drugdosagetext>2 TABLETS DIE AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugdosagetext>25 MG HS + 10 MG PRN (MAX ONCE A DAY)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100114</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146585-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-10P-028-0669591-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <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>20100817</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</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>EFFEXOR XR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</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>ZYPREXA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS INFECTIVE</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146586-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-10P-020-0688351-00</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>AMNIOTIC CAVITY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UMBILICAL CORD ABNORMALITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146587-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MYLANLABS-2010S1022056</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>CONGENITAL HAND MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL ANTICONVULSANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER ANOMALY CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FUSION ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TALIPES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugauthorizationnumb>077254</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146588-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-MYLANLABS-2010S1020724</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOTIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugauthorizationnumb>075278</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIMICAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLDESAM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETON /00072502/</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146589-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DE-MYLANLABS-2009S1006670</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>62</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOWER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MTX /00113801/</medicinalproduct>
        <drugauthorizationnumb>081235</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALOFALK /00000301/</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL DISCOMFORT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLSAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080828</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROSANOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENALAPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146590-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-CELGENEUS-062-21880-10011312</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>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090817</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEXANE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100111</drugenddate>
        <drugtreatmentduration>168</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONDRONAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVAMINSULFON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DELIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100111</drugenddate>
        <drugtreatmentduration>168</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146591-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010162129</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>75 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100927</drugenddate>
        <drugtreatmentduration>81</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SITAGLIPTIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146592-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010156237</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>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>200 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCULOSKELETAL DISCOMFORT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146593-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010151018</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>62.585</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALAVERT</medicinalproduct>
        <drugauthorizationnumb>021375</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASAL CONGESTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101111</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146594-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010149491</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL PM</medicinalproduct>
        <drugbatchnumb>E57954</drugbatchnumb>
        <drugauthorizationnumb>021393</drugauthorizationnumb>
        <drugdosagetext>1 DF, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146595-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010152085</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>74.83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugbatchnumb>E83222</drugbatchnumb>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>1 DF, EVERY 5 H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUS HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101114</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugindication>SINUS CONGESTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146596-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010148517</companynumb>
    <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>ADVIL</medicinalproduct>
        <drugbatchnumb>E73046</drugbatchnumb>
        <drugauthorizationnumb>020402</drugauthorizationnumb>
        <drugdosagetext>2 LIQUI-GELS</drugdosagetext>
        <drugindication>MYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugauthorizationnumb>020402</drugauthorizationnumb>
        <drugindication>INFLAMMATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146597-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010152438</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>55.329</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL PM</medicinalproduct>
        <drugauthorizationnumb>021393</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146598-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010153477</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>61.224</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugbatchnumb>D70899</drugbatchnumb>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>1 TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugindication>DYSMENORRHOEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146599-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010164132</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60.771</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugauthorizationnumb>050670</drugauthorizationnumb>
        <drugdosagetext>250 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugdosagetext>250 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146600-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010148509</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL PM</medicinalproduct>
        <drugauthorizationnumb>021393</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146601-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010157285</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL SENSATION IN EYE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYSTANE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>DRY EYE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELCHOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>12.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>2 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CITRATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MEDICAL DIET</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B3 (NICOTINIC ACID AMIDE)</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MEDICAL DIET</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MEDICAL DIET</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146602-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161870</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</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>12.5 MG (3), UNK</drugdosagetext>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146603-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101204</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010164169</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>88.435</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIKOSYN</medicinalproduct>
        <drugauthorizationnumb>020931</drugauthorizationnumb>
        <drugdosagetext>500 UG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVANE</medicinalproduct>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugdosagetext>180/24 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONTELUKAST SODIUM</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIURETIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146604-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161650</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146605-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010150969</companynumb>
    <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>ADVIL</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146606-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010148528</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>145</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugauthorizationnumb>020402</drugauthorizationnumb>
        <drugdosagetext>6 TO 12 CAPSULES DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146607-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-HQWYE019222MAR04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>48.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146608-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010148421</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>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT TAMPERING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL PM</medicinalproduct>
        <drugbatchnumb>E69201</drugbatchnumb>
        <drugauthorizationnumb>021393</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146609-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010163226</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>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugdosagetext>80 MG, 2X/DAY</drugdosagetext>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugindication>BORDERLINE PERSONALITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146610-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010165223</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>136.05</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIMB DISCOMFORT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>JOINT SWELLING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
        <drugdosagetext>4 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLADDER DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORETHINDRONE</medicinalproduct>
        <drugdosagetext>5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugdosagetext>500 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146611-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010145472</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>NORMAL TENSION GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>CONJUNCTIVITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101111</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>CONJUNCTIVITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101111</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101112</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146612-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010164050</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>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOVIAZ</medicinalproduct>
        <drugauthorizationnumb>022030</drugauthorizationnumb>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLADDER DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYTRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>81 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
        <drugdosagetext>0.6 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>300 MG, 4X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugdosagetext>88 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>300 MG, 3X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOLAZONE</medicinalproduct>
        <drugdosagetext>2.5 MG, WEEKLY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>30 IU, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugdosagetext>7.5/750</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>18 UG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CILOSTAZOL</medicinalproduct>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146613-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010164145</companynumb>
    <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>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146614-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010160660</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146615-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010113712</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.168</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, 1X/DAY FOR 3 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>.5 MG, 2X/DAY FOR 4 DAYS</drugdosagetext>
        <drugindication>TOBACCO ABUSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>1 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091215</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146616-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010090279</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87.528</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146617-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-HQWYE154621OCT05</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>0.625 MG/ 5MG</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146618-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161860</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>
      <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>7146619-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161483</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DETROL</medicinalproduct>
        <drugauthorizationnumb>020771</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146620-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-AMGEN-NORSP2010007062</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SCLERITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146621-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-AMGEN-ARGSP2010007058</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146622-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AMGEN-FRASP2010007054</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL HERPES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2X/WEEK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101011</drugenddate>
        <drugtreatmentduration>1380</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146623-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7030381</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100105</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146624-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7030383</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>119</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUNNEL VISION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080312</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>BLOOD TRIGLYCERIDES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146625-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0033565</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>ARTERIOVENOUS MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091005</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146626-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0034082</companynumb>
    <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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100805</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146627-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7022825</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146628-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7024599</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 PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBARACHNOID HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UROSEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
        <drugindication>MUSCLE SPASTICITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLYGAM</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146629-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7026613</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 LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101026</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146630-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0034056</companynumb>
    <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>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091222</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146631-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-GILEAD-E2B_00000870</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GUILLAIN-BARRE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBRISENTAN</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>THALASSAEMIA BETA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FILICINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONE-ALPHA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGA-CALCIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINTROM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100909</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146632-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0034019</companynumb>
    <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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101130</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146633-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-GILEAD-E2B_00000955</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBRISENTAN</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>5MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ILOPROST</medicinalproduct>
        <drugdosagetext>5MCG SIX TIMES PER DAY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL</medicinalproduct>
        <drugdosagetext>50MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146634-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE201008007824</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>77</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugdosagetext>1870 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100707</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>140 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100630</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146635-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ELI_LILLY_AND_COMPANY-BR201012001174</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>8 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101124</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>350 UG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>1000 IU, UNKNOWN</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101122</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORFINE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146636-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201010003346</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>CAPILLARY LEAK SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugdosagetext>1000 MG/M2, WEEKLY (1/W)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>125 MG/M2, WEEKLY (1/W)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100821</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146637-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201012000008</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>
      <patientweight>36.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>UNK, OTHER</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091127</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>UNK, OTHER</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091127</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANVITAN</medicinalproduct>
        <drugdosagetext>0.5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100309</drugenddate>
        <drugtreatmentduration>114</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXOCOBALAMIN</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100120</drugenddate>
        <drugtreatmentduration>66</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091127</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALONAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAIXAN                             /00256202/</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091127</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146638-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0032575</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 ASSIST DEVICE INSERTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101003</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146639-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2009-BP-14532BP</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>109</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE</medicinalproduct>
        <drugdosagetext>8 PUF</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE</medicinalproduct>
        <drugauthorizationnumb>020291</drugauthorizationnumb>
        <drugdosagetext>8 PUF</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugdosagetext>50 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA PERIPHERAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOPLUS MET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRA</medicinalproduct>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLOPIDINE BESFATE</medicinalproduct>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146640-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-12565BP</companynumb>
    <primarysource>
      <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>SPIRIVA</medicinalproduct>
        <drugbatchnumb>003817A,0D1007</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>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COSOPT</medicinalproduct>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146641-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-GENENTECH-301291</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAIR TEXTURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNODEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100505</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>750 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVALGINA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DORFLEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146642-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-10P-062-0687461-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PROSTATIC SPECIFIC ANTIGEN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101111</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146643-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-ABBOTT-10P-090-0689085-00</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021906</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021906</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021906</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100906</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
        <drugdosagetext>600MG DAILY</drugdosagetext>
        <drugindication>ANTIRETROVIRAL THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE (EPIVIR HBV)</medicinalproduct>
        <drugdosagetext>300MG DAILY</drugdosagetext>
        <drugindication>ANTIRETROVIRAL THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugdosagetext>2 TABS DAILY</drugdosagetext>
        <drugindication>ANTIRETROVIRAL THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFMINOX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CAESAREAN SECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHERGINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UTERINE CONTRACTIONS ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHERGINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACACLOFENAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UTERINE CONTRACTIONS ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM HYDROXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LAXATIVE SUPPORTIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTACID THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYTOCIN 5IU</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>UTERINE CONTRACTIONS ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100915</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146644-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-10P-028-0689312-00</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>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING OF BODY TEMPERATURE CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UROZIDE</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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146645-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-10P-062-0688682-00</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>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146646-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-10P-087-0689245-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020708</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080419</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BASEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETHINYL ESTRADIOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER STAGE IV</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080516</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146647-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-10P-020-0688729-00</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNIOTIC CAVITY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE SEPARATION OF PLACENTA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UMBILICAL CORD ABNORMALITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE CONTRACTIONS ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DACTIL OB</medicinalproduct>
        <drugindication>THROMBOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146648-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-10P-028-0687898-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52.664</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101017</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146649-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0688803-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64.468</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>SPONDYLOARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>SPONDYLOARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146650-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0683461-00</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>CAROTID ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR CALCIFICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100501</drugenddate>
      </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>ATENOLOL</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>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</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>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146651-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-09P-167-0586796-00</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>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLARICID</medicinalproduct>
        <drugbatchnumb>7320</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-DYDRAMOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146652-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GENENTECH-276795</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>100</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081020</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146653-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GENENTECH-305436</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD LACTIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENITAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>H0053</drugbatchnumb>
        <drugdosagetext>1 G, PRN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILUDAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-CODAMOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESLORATADINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILPAR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROFURANTOIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPTAC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101020</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146654-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AMGEN-FRASP2010007298</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>AORTIC DISSECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION ATRIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VECTIBIX</medicinalproduct>
        <drugdosagetext>250 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101029</drugenddate>
        <drugtreatmentduration>122</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMALINE                           /00764901/</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLINIQUE ACIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACILE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UFT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146655-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EC-AMGEN-ECUSP2010006309</companynumb>
    <primarysource>
      <reportercountry>ECUADOR</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CEREBRAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTATIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugdosagetext>50 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146656-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-GENENTECH-297280</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PROLACTIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>H0040</drugbatchnumb>
        <drugdosagetext>1ST INFUSION, ROUTE AS 1 GRAM</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091014</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>H0040</drugbatchnumb>
        <drugdosagetext>1 G, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091029</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugdosagetext>ALENDRONATE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75 MG, QAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>FREQUENCY: DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>40MG DAILY TO 5GM DAILY OVER 16</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE ACETATE</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE ACETATE</medicinalproduct>
        <drugdosagetext>12.5 MG, 1/WEEK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>1 G, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>PRE MED.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIRITON</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIRITON</medicinalproduct>
        <drugdosagetext>PREMED.  DRUG NAME REPORTED AS CHLOROPHENAMINE.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICHEW</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DELTACORTILEN</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM/VITAMIN D</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>12.5 MG, 1/WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNE GLOBULIN NOS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MYOSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugdosagetext>X1 DOSE 30 MINS PREMABTHERA INFUSION.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugdosagetext>X1 DOSE 30 MINS PREMABTHERA INFUSION.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DELTACORTRIL</medicinalproduct>
        <drugdosagetext>DRUG NAME DELTACORTRIL 5 MG.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNE GLOBULIN IV NOS</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MYOSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIPIPRAZOLE</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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146657-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10112571</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>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100607</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146658-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2010BH028539</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>ATRIAL TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146659-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-GENENTECH-307326</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FORMICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUNGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1000 MG, Q15D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080804</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MODURETIC 5-50</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUTHYROX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>THYROID CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METICORTEN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080721</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146660-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070917</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-GENENTECH-310787</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146661-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10090512</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 HUMAN CHORIONIC GONADOTROPIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugdosagetext>10-15 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146662-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010161878</companynumb>
    <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>DIMETAPP</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146663-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-GENENTECH-310634</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101020</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HELICID</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>20 MG, QAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLPRIL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>10 MG, QAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLOZEK</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>5 MG, QAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METYPRED</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>2 MG, QAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTEMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>70 MG, 1/WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146664-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAXTER-2010BH028616</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA FUNGAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EPENDYMOMA MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EPENDYMOMA MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EPENDYMOMA MALIGNANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146665-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-BAXTER-2010BH029445</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</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>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETROPERITONEAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146666-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-CELGENEUS-143-21880-10120065</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>020785</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENDOXAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STEROIDS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146667-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10120268</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>BLOOD CREATININE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090721</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146668-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10110456</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>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146669-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10120053</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>54.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100819</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOETIN ALFA</medicinalproduct>
        <drugdosagetext>60000 UNITS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101128</drugenddate>
        <drugtreatmentduration>114</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOETIN ALFA</medicinalproduct>
        <drugdosagetext>60000 UNITS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101124</drugenddate>
        <drugtreatmentduration>114</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146670-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13534BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>003420A,0D1007</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>ADVAIR</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146671-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-AMGEN-CHNSP2010007243</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PITUITARY TUMOUR BENIGN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, WEEKLY, TOTALLY 12 WEEKS SO FAR</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100831</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146672-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-10102813</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101025</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIDOPHILLUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHONDROITIN + GLUCOSAMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ-10</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugdosagetext>1 PUFF</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>ALLERGIC COUGH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugdosagetext>200 UNIT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugindication>NEUTROPENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAW PALMETTO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT B12</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VORINOSTAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELCHOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146673-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-10P-028-0689358-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>51.302</patientweight>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRENTEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENTOXISYLLINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RALLEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146674-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2010160565</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>469 MG/KG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146675-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-AMGEN-SWESP2010007274</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL CARCINOMA</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>20031022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146676-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0032805</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>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146677-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0034045</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146678-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2010-0034006</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 FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100211</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146679-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-AMGEN-GRCSP2010006201</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</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>20071113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOSORDIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090707</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090707</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOZAL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090707</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090707</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146680-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2010140482</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</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>CARDIAC ARREST</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>CORASPIN</medicinalproduct>
        <drugdosagetext>81 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>ONCE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146681-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-PFIZER INC-CO-WYE-H18391810</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</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>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101017</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>500-1000 MG AS NEEDED</drugdosagetext>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
        <drugdosagetext>DOSE NOT PROVIDED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GINKGO ^SYXYL^</medicinalproduct>
        <drugindication>PAIN IN EXTREMITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GINKGO ^SYXYL^</medicinalproduct>
        <drugindication>VARICOSE VEIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugdosagetext>DOSE NOT PROVIDED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARALEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>500 MG, AS NEEDED</drugdosagetext>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE</medicinalproduct>
        <drugdosagetext>50 UG, 1X/DAY</drugdosagetext>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>DOSE NOT PROVIDED</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146682-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CZ-ABBOTT-10P-217-0689445-00</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>ALCOHOL POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRAUMATIC BRAIN INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugdosagetext>2 IN 1 DAY; 1000MG-0-500MG PER DAY</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORIS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIDUM RISEDRONICUM(RISENDRONAT)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLECALCIFEROL; CA, MG, ZN, MN, CU, B(CALTRATE PLUS)</medicinalproduct>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146683-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0640078-00</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>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100127</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100421</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146684-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0630573-00</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>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOFT TISSUE INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146685-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-08P-087-0491142-00</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOPINAVIR/RITONAVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021906</drugauthorizationnumb>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARUNAVIR ETHANOLATE</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISPHOSPHONATES</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISPHOSPHONATES</medicinalproduct>
        <drugindication>COMPRESSION FRACTURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSAIDS</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSAIDS</medicinalproduct>
        <drugindication>COMPRESSION FRACTURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146686-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ABBOTT-10P-144-0685940-00</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EDUCATIONAL PROBLEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PETIT MAL EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146687-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-10P-028-0689355-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN XL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050775</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN XL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050775</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFZIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146688-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-10P-087-0667882-00</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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100414</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100408</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM RISEDRONATE HYDRATE</medicinalproduct>
        <drugdosagetext>WEEKLY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>WEEKLY</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN SODIUM HYDRATE</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEPOTASTINE BESILATE</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100708</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100527</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100527</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146689-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL238353</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABSCESS LIMB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATOMYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P103316</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070727</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1021305</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>1 MG, QWK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146690-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13742BP</companynumb>
    <primarysource>
      <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>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>908344A</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>BRONCHITIS CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101203</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146691-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-BP-13471BP</companynumb>
    <primarysource>
      <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>EAR DISCOMFORT</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>20091101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <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>20101128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146692-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-AP-00610AP</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>94</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <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>20100619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
        <drugtreatmentduration>153</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101125</drugstartdate>
        <drugtreatmentduration>153</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
        <drugdosagetext>DISCUS, 2X50 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLIXOTIDE DISCUS</medicinalproduct>
        <drugdosagetext>DISCUS, 2X500 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOSPIREX 300</medicinalproduct>
        <drugdosagetext>2X300 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146693-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2010135025</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>CELL DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SALAZOPYRINE</medicinalproduct>
        <drugauthorizationnumb>007073</drugauthorizationnumb>
        <drugdosagetext>500 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100918</drugenddate>
        <drugtreatmentduration>51</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEXABRIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100819</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
        <drugdosagetext>15 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APRANAX</medicinalproduct>
        <drugdosagetext>550 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMALINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARDYFERON</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANZOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146694-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2010163494</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CALCULUS BLADDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146695-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010158044</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>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZULFIDINE</medicinalproduct>
        <drugauthorizationnumb>007073</drugauthorizationnumb>
        <drugdosagetext>1500 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZULFIDINE</medicinalproduct>
        <drugauthorizationnumb>007073</drugauthorizationnumb>
        <drugdosagetext>1750 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZULFIDINE</medicinalproduct>
        <drugauthorizationnumb>007073</drugauthorizationnumb>
        <drugdosagetext>2000 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZULFIDINE</medicinalproduct>
        <drugauthorizationnumb>007073</drugauthorizationnumb>
        <drugdosagetext>2250 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100219</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZULFIDINE</medicinalproduct>
        <drugauthorizationnumb>007073</drugauthorizationnumb>
        <drugdosagetext>2500 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZULFIDINE</medicinalproduct>
        <drugauthorizationnumb>007073</drugauthorizationnumb>
        <drugdosagetext>2750 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100225</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZULFIDINE</medicinalproduct>
        <drugauthorizationnumb>007073</drugauthorizationnumb>
        <drugdosagetext>3000 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100428</drugenddate>
        <drugtreatmentduration>59</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugdosagetext>660 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100225</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100225</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUROTROPIN</medicinalproduct>
        <drugdosagetext>4 IU, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100225</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBOFLAVIN TAB</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100225</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100225</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146696-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2010158711</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>55.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GLOMERULONEPHRITIS MEMBRANOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MESANGIOPROLIFERATIVE GLOMERULONEPHRITIS</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>20090203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090927</drugenddate>
        <drugtreatmentduration>237</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIMATIL</medicinalproduct>
        <drugdosagetext>100 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100706</drugenddate>
        <drugtreatmentduration>282</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugdosagetext>5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090821</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugdosagetext>100 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100713</drugenddate>
        <drugtreatmentduration>327</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>YOKUININTO</medicinalproduct>
        <drugdosagetext>2.5 G, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090306</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BOUIOUGITOU</medicinalproduct>
        <drugdosagetext>2.5 G, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090306</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCYRON</medicinalproduct>
        <drugdosagetext>2 TAB, 3X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>1 DF, 1X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>7146697-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20110411</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20101208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-PFIZER INC-2010152512</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugd